The classification of medical devices rules along with regulatory approval and registration by the CDSCO is under the control of Drug Controller General of India (DCGI). All medical devices in India follow a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945).

The Health Ministry of India has published new Medical Device and IVD regulations to enhance the country’s Drugs and Cosmetics Act for creating effective regulations. The government has notified Medical Devices Rules, 2017 on 31.01.2017 and it will come into force on January 1, 2018. The suggested medical device rules necessary for regulatory approval impact of the Medical device and IVD sector.

New Medical Devices Rules India, 2017 -Key Features for Regulatory approvals and Registrations:

  • It will be for the first time that there will be no requirement of periodic renewal of licenses/registrations. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered.
  • Further, the entire process starting from submission of application to grant of permission/licence will be processed through online electronic platform.
  • The registration document review, submission & tracking have become much simpler, efficient & transparent with the SUGAM system.
  • Timelines have been defined for most activities at the regulators end.
  • The new Rules “Medical Devices Rules, 2017”will help in developing quality standardization in the regulations of framework at par with international standards.
  • It has been made easier to apply for change notifications once the registrations certificate is obtained. This can be done in the section “Post Approval Change”.

Regulatory approvals mechanism: 

The new regulations will balance the usage of medical devices rules with International standards so as to smoothen manufacturing & importing of medical devices. National Medical Device Authority will receive authorization to promote the local medical device sector which includes safety standards, specific price limits, price control policy for surgical instruments.

At present there are 22 notified Medical devices under the Drugs & Cosmetics Act, 1940, and need to be registered with the CDSCO (Regulatory Body of India).

Sl: NoName of the Devices
1Disposable Hypodermic Syringes
2Disposable Hypodermic Needles
3Disposable Perfusion Sets
4In vitro Diagnostic Devices for HIV, HbsAg and HCV
5Cardiac Stents
6Drug Eluting Stents
7Catheters
8Intra Ocular Lenses
9I.V. Cannulae
10Bone Cements
11Heart Valves
12Scalp Vein Set
13Orthopaedic Implants
14Internal Prosthetic Replacements
15Ablation Device

Medical devices under the new Rules “Medical Devices Rules, 2017”are classified as per Global Harmonization Task Force (GHTF) based on associated risks,

  • Class A (low risk)
  • Class B (low moderate risk)
  • Class C (moderate high risk)
  • Class D (high risk)

 Authority for Regulatory approval along with Registration of Medical Devices:

Class B, Class C and Class D: The Central Licensing Class A and Class B: The State Licensing Authority is for registrations matters relating to these devices. Authority is responsible for providing the required licenses for the import and manufacture of Class C and Class D products. Companies those want to manufacture Class C and Class D along with Class A and Class B can send applications.

The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules.

As per the guidelines in the “The Medical Devices Rules, 2017” the list of Medical Devices and IVDs along with their risk based classification is announced in CDSCO Notice dated 29th June 2017.

LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS

The new draft for medical devices classification has larger groups of devices such as cannulas and stents into more specific sub groups such as ureteral stents, coronary stents. CDSCO have the classification of new sub groups using risk analysis methods required by the Medical Devices Rules 2017.

The below table is the draft list of medical devices along with their risk class.

A – LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS
Sl: NoRisk AnalysisDevices Name Intended Use
1Class ABolster SutureNon-latex plastic bolsters are used to hinder pressure of any temporary suture against the body during surgery.
2Cyclodialysis eye CannulaIt is a medical device used in the treatment of glaucoma where it creates a channel between the anterior chamber of the eye and the subarachnoidal space.
3Nasopharyngeal Catheter/NasopharyngealA catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction and Resuscitator by its registration
4Incontinence Urosheath DeviceA urine collector and accessories is a medical device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection.
5Umbilical occlusion deviceThese devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a new born infant.
6Urinary Drainage UnitA closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag
7PharynscopeInstrument used for inspecting the pharynx.
8Myringotomy Tube InserterRegulations for the registration of medical devices in india, which is used for grasping securely an aural ventilation tube whilst simultaneously presenting the device at the correct angle for the insertion of an aural ventilation tube
9Sacculotomy Tack InserterRegulations for the registration of medical devices in india, which is used repetitively ruptures the utricular membrane as the membrane expands under increased endolymphatic pressure
10Surgical StaplesSurgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
11Collection bagsBags intended for bile collecting, drainage purpose, stoma collection, and urinary collection or for other external collection use.
12Surgical DressingsDressing aerosol, non-adherent, dressing, periodontal, kit, dressing pad, dressing
13Orthodontic Bands/BraketBand or belt intended to provide support.
14AdhesiveAdhesive strip for minor skin cut, adhesive gel used on measuring electrodes or any similar use which does not comes with the body fluids.
1Class BA-V Shunt or Fistula AdapterA blood access device and accessories is a device intended to provide access to a patient’s blood for hemodialysis or other chronic uses.
2Eternal infusion PumpRegulations for the registration of medical devices in india, which is designed to provide nutrition to patients who are unable to ingest food, either because of recent surgery or because of the inability of various digestive organs to function properly
3Transcervical(Aminoscope) Endoscope and accessoriesRegulations for the registration of medical devices in india is designed for direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
4Forceps, endoscopicGrasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
5Anastomotic Micro vascular DeviceIt is used in anastomosis of veins and arteries normally encountered in microsurgical procedures
6Angiographic Guide Wire and AccessoriesIt delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
7Vessel Dilator for percutaneous CatheterizationA vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
8AngioscopeRegulations for the registration of medical devices in india, which is used to visually examine the interior of a blood vessel.
9Aspiration Needle and SyringeUsed for either laparoscopic aspiration or injection
10Tracheobronchial Suction CatheterClearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
11Cervical DrainRegulations for the registration of medical devices in india, which is used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress
12Rectal BalloonReducing the intrafraction motion and improving the sparing of rectal wall by reducing the rectal volume in the high-dose region, resulting in significant reduction in rectal toxicity.
13Biliary Stone Retrieval BasketIntend to extract stones in an antegrade fashion through an ampullary orifice previously treated by endoscopic sphincterotomy or less commonly with balloon dilation
14Contact Lens Bifola and DailyWorn to correct vision, or for cosmetic or therapeutic reasons
15Blood Administration kitsIt is used to administer blood from a container to a patient’s vascular system through a needle or catheter inserted into a vein
16Biopsy KitInvolving sampling of cells or tissues for examination.
17Tracheostomy Tube/Tracheal TubeA breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation
18Irrigating Syringescleaning debris away from the area the dentist is working on
19Intravenous CannulaThe IV Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices.
20Vial AdapterThe Regulations of medical devices in india is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
21Suprapubic, non-disposable Cannula and TrocarAn emergency measure for the relief of acute urinary retention or condition which require temporary and permanent drainage of bladder.
22Aortic CannulaThe Aortic Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components or to provide access to the Aorta.
23Arterial CannulaInserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples.
24Coronary Artery CannulaCannulation technique for left-sided coronary artery surgery
25Arthroscopy Drainage CannulaRegulations for the registration of medical devices in india, that is designed to provide maximized outflow, without interruption, during arthroscopic procedures (surgical procedure on a joint )
26Lacrimal CannulaUsed for probing and irrigating the lachrymal passages.
27Hemodialysis CannulaAllowing the arterial blood to flow to the dialyzer and the dialyzed blood to return from the dialyzer to the circulation through the cannula in the vein.
28Cannula InjectionIt is a small tube with an edge that is not sharp and an extrusion port or pore near the tip which is designed for a traumatic sub dermal injections of fluids or gels
29Uterine Insufflation CannulaAn Injection of radiopaque medium is given to visualize the interior of the uterus and fallopian tubes and air is used for insufflations of fallopian tubes with carbon di oxide to test their patency.
30Continuous Positive Airway Pressure Nasal Oxygen CannulaIt is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a person who is able to breathe spontaneously on their own
31Nasal Oxygen CannulaA medical device is used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
32General & Plastic Surgery CannulaUsed for general surgery and cosmetic surgery
33Vena Cava CannulaInserted into Vena Cava, taking deoxygenated blood to heart
34Venous CannulaRegulations for the registration of medical devices in india, that is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
35Venous CannulaRegulations for the registration of medical devices in india, which is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
36Ventricular CannulaFor use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
37Bronchial CannulaeA cannula used for holding the suction tube during the aspiration of bronchial secretions through a specific diameter bronchoscope
38Endoscopic/ Laparoscopic Surgical InstrumentAn electrosurgical cutting and coagulation device and accessories is a medical device intended to remove tissue and control bleeding by use of high-frequency electrical current.
39Intrafallopian System CannulaCannula inserted inside Fallopian tube.
40Cannulact or Lymph DuctA lymph duct is a great lymphatic vessel that empties lymph into one of the subclavian veins
41Esophageal obturatorInserted through a patient’s mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea.
42OropharyngealMedical devices in which it is inserted into a patient’s pharynx through the mouth to provide a patent airway.
43Cricothyrotomy KitIndicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed
44Balloon Catheter for Retinal ReattachmentAn instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball
45Gastric, Colonic, etc.) Irrigation and Aspiration CatheterUsed for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
46Suction Tip and CatheterSuction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.
47Angiographic CatheterDesigned to provide a pathway for delivering contrast media to selected sites in the device vascular system including the carotid arteries
48Arterial CatheterMedical devices is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to
facilitate placement and exchange of guidewires and other interventional devices.
49Balloon Type Catheter“Soft” catheter with an inflatable “balloon” at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
50Balloon Dialation Vessel CatheterRegulations for the registration of medical devices in india, which is intended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
51Bartholin Gland CatheterCatheter is used for the treatment of abscesses and cysts of the Hartholin gland.
52Bronchography CatheterRegulations for the registration of medical devices in india, which is intended to deliver therapeutic and diagnostic agents that are indicated or labelled for airway, tracheal or
bronchial delivery into selected and sub-selected regions of the airway tree
53Cholangiography CatheterDiagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures
54Anaesthetic Conduction CatheterAn anaesthesia conduction catheter is a flexible tubular device used to inject local anaesthetics into a patient and to provide continuous regional anaesthesia
55Continuous Flush CatheterRegulations for the registration of medical devices in India, which is intended for the controlled and selective infusion of
physician-specified fluids, including thrombolytics, into the peripheral vasculature.
56Continous Irrigation CatheterRegulations for the registration of medical devices in India, which is intended to be used to introduce fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
57Coude CathetersIt is a urinary catheter; It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
58Depezzer CatheterA tubular, flexible instrument, passed through body channels for withdrawal of fluids from a body cavity.
59Double lumen Female Urethrographic CatheterIntended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
60Epidural CatheterEpidural catheter is a very thin, flexible tube that is implanted into spine
61Esophageal Balloon CatheterRegulations for the registration of medical devices in india, which is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
62Eustachian CatheterIt is used to test Eustachian tube patency
63Guiding CatheterThe guide catheter provides support for device advancement.
64Haemodialysis CatheterA catheter used for exchanging blood to and from the haemodialysis machine from the patient.
65Intramuscular Pressure Monitoring CatheterA modified fibre optic transducer-tipped catheter system for measuring intramuscular pressures during exercise was determined.
66Intravenous CatheterA catheter that is inserted into a vein for supplying medications or nutrients directly into the bloodstream or for diagnostic purposes such as studying blood pressure
67Jejunostomy CatheterUsed for intraoperative feeding jejunostomy
68Multiple Lumen CatheterIntended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.
69Nasal Oxygen CatheterMedical devices used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
70Radiographic (Non Vascular) CatheterInterventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
71Rectal CatheterIt is inserted into the rectum in order to relieve flatulence which has been chronic and which has not been alleviated by other methods.
72Retention Type CatheterThis type of catheter is placed into the bladder and secured there for a period of time.
73Retention Type Balloon CatheterIt has a balloon at the distal end, which is inflated with sterile water or saline to prevent the catheter from slipping out of the bladder
74Salpngography CatheterUsed for injection of contrast medium into the fallopian tube(s) for selective salpingography
75Single Needle Hemodialysis Catheter/Blood linesThe single-needle dialysis, in which case only one cannula or a single-lumen catheter is used to access the blood
76Straight CatheterIt is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection
77Subclavian CatheterCatheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein),
78Suprapubic CatheterA suprapubic catheter is a thin, sterile tube used to drain urine from bladder
79Umblical Artery CatheterUmbilical artery catheterization provides direct access to the arterial blood supply and allows accurate measurement of arterial blood pressure, a source of arterial blood sampling, and intravascular access for fluids and medications
80Upper Urinary Tract CatheterThe catheter to the bladder and subsequently to the upper urinary tract
81Urethral Catheter/Nelaton Catheter/ Foley CatheterA long, small gauge catheter designed for insertion directly into a ureter, either through the urethra and bladder or posteriorly via the kidney.
82Urethrographic Male CatheterA catheter used to pass into a man’s bladder.
83Chorionic Villus Sampling CatheterAn ultrasound guides a thin catheter through the cervix to your placenta. The chorionic villi cells are gently suctioned into the catheter.
84Percutaneous Retrieval DeviceEmbolization of the occlusion device after percutaneous closure of atrial septal defect (ASD) is a potential disastrous complication.
85Sclerotherapy Needle/ CatheterSclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR)
86Water Jet Renal CatheterA medical device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit.
87Angiographic Injector and SyringeMedical devices used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography
88Auto transfusion ApparatusMedical devices used to collect and reinfuse the blood lost by a patient due to surgery or trauma
89Colonoscope (Gastro-Urology )The endoscopic examination of the large bowel and the distal part of the small bowel with a CCD camera or a fibre optic camera on a flexible tube passed through the anus.
90Disposable Hypodermic SyringesIntend to inject fluids into or withdraw fluids from the body.
91Transfusion or Perfusion sets for single useTransfusion Set is used to administer blood/drugs to a patient’s vascular system through a needle or catheter inserted into a vein.
92Dialysate Tubing and ConnectorA tubing connector adapted for peritoneal dialysis connections between tubing sets and containers of dialysate
93Peritoneal Dialysis UnitPeritoneal dialysis (PD) is a treatment for patients with severe chronic kidney disease.
94Penrose DrainA Penrose drain is a surgical device, placed in a wound to drain fluid.
95Sump DrainA drain consisting of an outer tube vented to the outside with a smaller tube within it that is attached to a suction pump; both have multiple perforations that allow fluid and air to be carried away through the suction tube.
96Vent DrainTo release or discharge (steam, for example) through an opening.
97Wound Drainage and closed drainage systemIntended for evacuation of biological fluid from wound or body cavity during surgical procedure or in wound care management.
98AnoscopeIt is inserted a few inches into the anus in order to evaluate problems of the anal canal
99CholedochoscopeUsed to see into the central bile duct which is a narrow channel.
100CystourethroscopeAn endoscope used for the visual examination of the posterior urethra and bladder
101Endoscope and AccessoriesAn endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
102Fiber optic EndoscopeAn endoscope can consist of: a rigid or flexible tube. A light delivery system to illuminate the organ or object under inspection. The light source is normally outside the body and the light is typically directed via an optical fibre system
103Neurological EndoscopeA neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain
104Transcervical (Amnioscope) and AccessoriesA transcervical endoscope is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
105Oesophagus Gastro SuodenoscopeTo examine the lining of oesophagus, stomach, and duodenum. The oesophagus is the muscular tube that connects your throat to stomach and the duodenum, which is the upper part of small intestine
106EsophagoscopeAn endoscope for inspecting the interior of the oesophagus
107gastro scopeAn endoscope for inspecting the interior of the stomach
108HysteroscopeAn endoscope used for the visual examination of the cervix and interior of the uterus
109LaparoscopeA usually rigid endoscope that is inserted through an incision in the abdominal wall and is used to examine visually the interior of the peritoneal cavity—called also peritoneoscope
110MediastinoscopeAn endoscope used in mediastinoscopy
111PanendoscopeA cystoscope that gives a wide- angle view of the bladder.
112PeritoneoscopeA usually rigid endoscope that is inserted through an incision in the abdominal wall and is used to examine visually the interior of the peritoneal cavity—called also peritoneoscope
113ProctoscopeAn instrument used for dilating and visually inspecting the rectum and lower portion of the sigmoid colon
114ResectoscopeAn instrument consisting of a tubular fenestrated sheath with a sliding knife within it that is used for surgery within cavities
115Fiberoptic Intubation ScopeFiberoptic intubation involves threading an endotracheal tube over the shaft of a flexible fiberoptic scope.
116NephroscopeAn endoscope used for inspecting and passing instruments into the interior of the kidney
117SigmoidscopeAn endoscope designed to be passed through the anus in order to permit inspection, diagnosis, treatment, and photography especially of the sigmoid colon—called also proctosigmoidoscope
118SphyncteroscopeAn endoscope and accessories is a device used to provide access, illumination, and allowobservation or manipulation of body cavities, hollow organs, and canals
119OpthalmoscopeThe Ophthalmoscope allows easy entry into the eye, and a 5X larger field of view of the fundus in an undilated eye, providing better images of the retinal changes caused by hypertension, diabetic retinopathy, glaucoma, and papilledema.
120Aspiration and Injection NeedleA thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer.
121Insulin Injector/Insulin Syringes/Insulin Needles/Pen Needles for insulinUsed to inject insulin for the treatment of diabetes
122Medication InjectorA subcutaneous injection is a method of administering medication.
123In-Vitro Fertilization/ Embryo Transfer CatheterA cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient
124Dry Eye InsertIt is indicated in patients with moderate to severe dry eye syndromes, including kerato conjunctivitis sicca
125laryngoscopeThe conventional laryngoscope consists of a handle containing batteries with a light source, and a set of interchangeable blades.
126Biopsy Needle KitA set of neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory
127Angiographic NeedleAngiographic needle has a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel.
128Mammary Biopsy NeedleThe growth sample is suctioned out through a needle or cut out using a surgical procedure
129Blood Collecting NeedleNeedle used to collect blood through syringe
130Bone Marrow NeedleNeedle inserted in Bone Marrow to collect sample
131Gynaecological Cerclage NeedleIt is a loop like instrument used to suture the cervix.
132Cholangiography NeedleThe aspirating needle is passed through the patient’s skin and liver tissue until the tip penetrates one of the hepatic ducts
133Anaesthetic Conduction NeedleAn anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia
134Dental NeedleDental Needles have the ultra-sharp bevel design with triple faceting, which minimises patient trauma
135Emergency Airway NeedleEmergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
136Endoscopic NeedleUsed to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
137Fistula NeedleTo connect blood lines with the blood vessels through needles when dialysis is carried out
138Epidural NeedleRegulations for the registration of medical devices in india, which is Intended for transient delivery of anaesthetics to provide regional anaesthesia or to facilitate placement of an epidural catheter
139Vacutainer Flashback needlesMedical devices used with evacuated blood collection tube for collection of venous blood.
1403 way stop cock as an accessoryIt is indicated for fluid flow directional control and for providing access port for administration of solution, withdrawal of fluid and pressure monitoring
141Gastro-Urology NeedleIntended for gastroenterology biopsy
142Single Lumen Hypodermic NeedleA hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
143Neurosurgical Suture NeedleA needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
144Oocyte Aspiration NeedleMission to collect the maximum amount of undamaged oocytes in a short time as possible.
145Opthalmic NeedleNeedle used for Ophthalmic Surgery
146Pneumoperitoneum Simple NeedleInserting a Veress needle through the abdominal wall inside the peritoneal cavity.
147Radiographic NeedleIdentifying lost surgical needles
148Sclerotherapy Needle/ CatheterIt is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
149Oxygen administration KitAdministered for various cardiac and respiratory emergencies, emergency oxygen kits and supplies are available without a prescription for first aid
150Passer wire OrthopaedicTo fit through a small incision on the clavicle and curve around the coracoids
151Fluid Delivery tubingTube used to deliver fluid in body
152Fluid Delivery tubingTube used to deliver fluid in body
153Gastro-Urology Probe and DirectorGuiding probe, in particular for an endoscope for surgical endoscopy with laser light.
154Common duct ProbeGuiding probe, in particular for an endoscope for surgical endoscopy with laser light.
155ENT ProbeGuiding probe, in particular for an endoscope for surgical endoscopy with laser light.
156Periodontic ProbeA periodontal probe is an instrument in dentistry commonly used in the dental armamentarium.
157Trabeculotomy ProbeTrabeculotomy Probes are a commonly used tool in glaucoma surgeries
158Laproscope Heating tissue ProbeA heater probe can achieve extreme temperatures that conduct heat to the tissue
159Laser ProbeIt is a laser-based voltage and timing waveform acquisition system which is used to perform failure analysis on flip-chip integrated
160Radiofrequency Lesion ProbeA radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired
161Temperature ProbeUsed to measure core body temperature via placement in the oesophagus,
162Nuclear Uptake ProbeA nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region.
163Bronchoscope Rigid TubeIt is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiber optic light source and carrier to provide illumination.
164Grastroplasty Calibration TubeIs used in silastic ring gastroplasty and is based on a tube of the desired size in the lumen.
165Colon TubeColon Tubes also called “Tips” or even Catheters are inserted from the anus, through the rectum to deliver your enema solution into the colon (large intestine).
166Connecting TubeUsed to provide connection to a drainage bag.
167Decompression TubeDecompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
168Double Lumen for intestinal Decompression and/or Intubation TubeTracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs.
169Drainage TubeA surgical drain is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists.
170Oesophageal Blakemore TubeIt is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
171Oesophageal Sengtaken TubeIt is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone
172Gastro-Enterostomy TubeTube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
173Gastrointestinal TubeA gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach
174Heart-Lung Bypass Unit TubeA tube will be placed in your heart to drain blood to the machine.
175Laryngectomy TubeIt is a hollow tube made of metal or plastic. It is put into the breathing tube in your neck called the trachea so you can breathe
176Levine TubeUsed for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
177NasoGastric Tube/ Ryles TubeIt is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories
178Nephrostomy TubeThe nephrostomy tube drains urine from kidney into a collecting bag outside the body.
179Orthodontic TubeAn orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bumpers, face bows and other devices used to move the teeth.
180Rectal TubeA rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence.
181Stomach Evaculator(Gastric Lavage) TubePassage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
182Tonsil Suction TubeUsed to suck out stones in tonsils.
183Tracheal (Endotracheal) TubeInserts the tube with the help of a laryngoscope, an instrument that permits to see the upper portion of the trachea, just below the vocal cords.
184Endolymphatic Shunt TubeDuring a surgical procedure in which it is placed in the membranous labyrinth of the inner ear to drain excess fluid.
185Orthodontic Guide WireA wire conforming to the alveolar or dental arch that can be used with dental braces as a source of force in correcting irregularities in the position of the teeth
186Bone WireIntended to be used for bone stabilization in the hand and wrist.
187Intra Osseous Fixation WireStabilization of fractured bony parts by direct fixation to one another with surgical wires
188Ligature Wireoffer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire
189Collection BagsIntended for breathing, , enteral feeding, haemostatic (blood collection), I.V. container and accessories
190Surgical DressingsDressing-gel, dressing- permeable, moisture dressing, tracheostomy tube dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
191Cotton Grudges and bandagesAdhesive bandages, Gauge bandages, Pressure bandages, Traction bandages, Medical Absorbent (fiber) bandages
192Sterile DrapesIt is intended for use during various surgeries.
193Casting tapes/Splint RollsA prosthetic and orthotic accessory, intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
194Disinfectants and insecticidesAn agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device.
195Anticoagulant SolutionsFor pre-storage leukocyte reduction of whole blood or whole blood or blood component initiated between 4 and 7 hours after collection if whole blood is stored at ambient temperature
196ManifoldsIndicated for fluid flow directional control and for providing access port/ports for administration of a solution
197Surgical WireIt is a medical device used to hold body tissues together after an injury or surgery.
198Pacemaker polymeric mesh bagA pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator.
199Bone capRegulations for the registration of medical devices in india, which is intended to be implanted to cover the end of a bone.
200Orthopaedic Plates, clipersScrewsCervical orthosis, cervical -thoracic, rigid, limb brace, lumbar, lumbo-sacral, rib fracture, sacroiliac, thoracic oethosis.
201NebulizerMedical devices intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing includes heated, ultrasonic, gas, venturi, and refillable nebulizers.
1Class CVein Ablation DeviceIt is a non-thermal, minimally-invasive choice for treating the source of varicose veins, providing patients with immediate recovery and a return to normal daily routines
2Thermal Ablation DeviceDestruction of tissue by application of heat. Ablation of the endometrium as a treatment for menorrhagia is performed by placing a balloon filled with hot water in the uterine cavity.
3Injector Type actuator syringeA syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal
4Transabdominal (Fetoscope) Aminoscope and AccessoriesIt is a medical device in which is designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities
5Anastomosis Device for Microvascular SurgerySuitable in microvascular surgery for repairing severed blood vessels and inserting vein grafts.
6Anastomosis Device for Gastroenterology Urology UseIt is a surgical procedure to establish communication between two formerly distant portions of the intestine
7Anaesthetic Conduction KitAn anaesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anaesthesia. The device may contain syringes, needles, and drugs.
8Ophthalmic Laser and AccessoriesAn ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam
9Embolic Particles SystemEmbolization particles are small and irregular flakes of polyvinyl alcohol, which are used for permanent occlusion within a blood vessel
10A-V Shunt CannulaIt is inserted into one of the client’s blood vessels to facilitator repeated hemodialysis.
11Anaesthesia conduction filterA micro porous filter used while administering to a patient injections of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid
12Anaesthesia conduction kitMedical devices that are intended for use in the administration of anaesthetic agents into the epidural space.
13Introducer SheathRegulations for the registration of medical devices in india, which is intended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
14Hemodialysis Catheter (Long Term )A dialysis catheter is a catheter used for exchanging blood to and from the hemodialysis machine from the patient. The dialysis catheter contains two lumens: Venous. Arterial
15Percuataneous Intravascular Long Term CatheterThe medical devices allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood;
16Percutaneous Long Term Intraspinal CatheterTo conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump
17Implanted Subcutaneous Intravascular Port & CatheterThe device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood
18Subcutaneous Intraspinal Port & CatheterCatheters used for both epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue
19Ventricular CatheterMedical devices used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
20Balloon Repair Kit CatheterMedical devices used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to affect the repair or replacement
21Micro-catheterRegulations for the registration of medical devices in india, which is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media
22Imaging CatheterIntended for use with the various medical imaging consoles.
23Custom Perfusion SystemIndicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure.
24Sealant, pit and FissureSealant is a protective plastic coating, which is applied to the biting surfaces of the back teeth.
25Contraceptive Occlusion Tubal DeviceA contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure. The devices are used to prevent pregnancy
26Suture Non Absorbable SyntheticNon-absorbable suture is comprised of surgical steel as well as synthetic non-absorbable sutures for use in general soft tissue approximation and ligation.
27Suture AbsorbableRegulations for the registration of medical devices in india, which is intended for use in general soft tissue approximation and ligation.
28Semi-Automatic Peritoneal Dialysate Delivery SystemThe source of dialysate may be sterile pre-packaged dialysate or dialysate prepared from dialysate concentrate and sterile purified water.
29Peritoneal Automatic Delivery SystemControls and monitors the dialysate circulating through the dialysate compartment of the dialyzer
30Hollow Fiber Capillary DialyzerRegulations for the registration of medical devices in india, which is intended for single use acute and chronic haemodialysis.
31Tympanostomy TubeIt is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear
32Surgical Polymeric MeshThe polymeric mesh comprises an absorbable polymeric fibre and a non-absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure
33Contrast Medium Automatic InjectorContrast material are inserted, piston plungers that deliver the contrast from the syringes, and pressure tubing that connects the syringe and vascular system of the patient.
34Thermal Dilution InjectorA thermo dilution injector is presented in which a pneumatically powered piston operates the plunger of a syringe to deliver a measured amount of injectate in an accurately predetermined time period.
35Y-ConnectorIt can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
36Retrieval BasketTo entrap and remove stones from biliary system
37Polymeric Surgical MeshThe polymeric mesh comprises an absorbable polymeric fibre and a non-absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure.
38Extra vascular Blood Flow ProbeAn extra vascular blood flow probe is an extra vascular ultrasonic or electromagnetic probe used in conjunction with a blood flow meter to measure blood flow in a chamber or vessel.
39Ultrasonic ProbeUltrasonic probe is a very important sensor which generate acoustic signals and also detect returned signals
40Feeding TubeA feeding tube is a device that’s inserted into your stomach through your abdomen. It’s used to supply nutrition when you have trouble eating
41Anastomosis Bypass TubeIt is anchored to mucosa and submucosa 3 centimetres proximal to a site of colocolonic anastomosis and later spontaneously evacuated by way of the rectum.
42Scalp Vein SetTo administer parental fluid/medication into patient’s vascular system.
43Wound Dressings/Bacteriostatic Wound DressingsIncludes Beads, Hydrophilic For Wound Exudate Absorption for wound care.
44Tissue ExpandersRegulations for the registration of medical devices are intended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
45Bio PatchesRegulations for the registration of medical devices are Intended for reconstruction and repair of defects of pericardium
46Haemostatic Gelatine Sponge /HaemostatRegulations for the registration of medical devices are Intended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes
47Surgical DressingsMaterial dressing, surgical, polylactic acid dressings.
48Male / Female CondomsCondom with nonoxynol-9, micro-condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intra vaginal condoms.
49Intra Uterine devicesIntrauterine device, contraceptive (iud), introducer, uterine balloon therapy devices
50Tubal Rings / Fallopian RingsContraception devices for female sterilization
51Endovascular suturing systemIt is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery.
52Pacemaker repair or replacement materialA pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, a battery or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.
53Annuloplasty ringAn annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment.
54Middle ear moldIt is a registration of the regulatory approval for medical devices that that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane.
55Ear, nose, and throat synthetic polymer materialIt is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck.
56Mandibular implant facial prosthesisIt is a registration of the regulatory approval for medical devices that Intended to be implanted for use in the functional reconstruction of mandibular deficits.
57Sacculotomy tack (Cody tack)It is a registration of the regulatory approval for medical devices that Intended to be implanted to relieve the symptoms of vertigo.
58Endolymphatic shunt It is a registration of the regulatory approval for medical devices that Intended to be implanted to relieve the symptoms of vertigo.
59An endolymphatic shunt tube with valveIt is a medical device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss.
60Tympanostomy tube it is a  registrations of the regulatory approval for medical devices that Intended to be implanted for ventilation or drainage of the middle ear.
61Hearing aidsIt is a wearable sound-amplifying medical device intended to compensate for impaired hearing.
62Vaginal pessaryit is a registrations of the regulatory approval for medical devices that is placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse, uterine retroposition) or gynecologic hernia.
63Fallopian tube prosthesisit is a registrations of the regulatory approval for medical devices that designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
64Vaginal stentIt is a registration of the regulatory approval for medical devices that used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
65Aqueous shuntIt is a registration of the regulatory approval for medical devices that intended to reduce intraocular pressure in the anterior chamber of the eye.
66Bone fixation cerclageIt is a registration of the regulatory approval for medical devices that Intended to use in the fixation of fractures.
67Intramedullary fixation rodIt is a registration of the regulatory approval for medical devices that Intended to be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
68bone fixation appliances and accessoriesUsed for fixation of fractures of the proximal or distal end of bones, for fusion of a joint; or for surgical procedures.
69Dental fillersit is a  registration of the regulatory approval for medical devices that Intended for the purpose of repairing a tooth.
70Orthopedic implant & accessoriesmedical devices Intended to replace a missing joint or bone or to support a damaged bone.
71Endosseous dental implantit is a  registrations of the regulatory approval for medical devices rules that Intended to be surgically placed in the bone of jaw arches to provide support for prosthetic devices, such as artificial teeth.
72Endosseous dental implant abutmentit is a  registrations of the regulatory approval for medical devices that that is Intended for use as an aid in prosthetic rehabilitation.
73Dental implant & accessoriesA dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
74Bone grafting materialIntended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
75Pacemaker lead adaptorit is a registrations of the regulatory approval for medical devices rules that used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.
76Cardiovascular intravascular filterIt is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli from flowing into the right side of the heart and the pulmonary circulation.
77Permanent Pacemaker electrodeA medical devices consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart.
78Penile inflatable implantA penile inflatable implant is a medical device which is implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. This device is used in the treatment of erectile impotence.
79Penile rigidity implantIt is a registration of the regulatory approval for medical devices rules that is implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be  used in men diagnosed as having erectile dysfunction
80Artificial Urinary Sphincters implantsIt is used to prevent incontinence by occluding the urethra.
81Ureteral stentAn ureteral stent is a tube-like implanted medical devices that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine
82Implanted mechanical/hydraulic urinary continence deviceAn implanted mechanical/hydraulic urinary continence device is a medical devices used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra.
83Implantable transprostatic tissue retractor systemIt is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate
84External Infusion PumpMedical devices which are Intended for drug delivery to the patient’s body.
85Intraocular lensIntraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia
86Breast implantBreast implant is used to increase the breast size.
87Hernia Surgical mesh
Implant
Hernia surgical mesh implant is a medical devices that is used to provide additional support to weakened or damaged tissue
88Esophageal stentAn esophageal stent is a stent (tube) placed in the oesophagus to keep a blocked area open so the patient can swallow soft food and liquids
89Biliary stentsBiliary stents provide bile drainage from the gallbladder, pancreas and bile ducts to the duodenum in conditions such as ascending cholangitis due to obstructing gallstones
90Glaucoma drainage stentsGlaucoma drainage stents are recent developments and are awaiting approval in some countries. They are used to reduce intraocular pressure by providing a drainage channel.
91Duodenal stentsDuodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions
92Colonic stentA colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has become blocked (obstructed). This blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall.
93Pancreatic stentPancreatic duct stents are often placed in patients who have chronic pancreatitis
94Bifurcation StentIt is a registration of the regulatory approval for medical devices rules that Intended for improving the side branch luminal diameter of arterial bifurca tion liaisons.
95Carotid Stent SystemIt is a registration of the regulatory approval for medical device rules that Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
96Peripheral Stent SystemA Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
97Pedicle screw spinal systemIt is a registration of the regulatory approval for medical devices rules that are intended to provide immobilization and stabilization of spinal segments
98Ankle joint metal/composite semi-constrained cemented prosthesisAn ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
99Ankle joint metal/polymer non-constrained cemented prosthesisIt is a registration of the regulatory approval for medical devices that intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across-the-joint.
100Ankle joint metal/polymer non-constrained cemented prosthesisit is a  registrations of the regulatory approval for medical devices that intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across-the-joint.
101Elbow joint metal/polymer constrained cemented prosthesisAn elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.
102Elbow joint metal/polymer semi-constrained cemented prosthesisAn elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint
103elbow joint radial (hemi-elbow) polymerAn elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
104Elbow joint humeral (hemi-elbow) metallic uncemented prosthesisit is a  registrations of the regulatory approval for medical devices rules that intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri
105elbow joint humeral (hemi-elbow) metallic uncemented prosthesisit is a  registrations of the regulatory approval for medical devices rules that intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri
106Finger joint metal/metal constrained uncemented prosthesisA medical devices intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
107Finger joint metal/metal constrained cemented prosthesisA finger joint metal/metal constrained cemented prosthesis is a medical devices intended to be implanted to replace a metacarpophalangeal (finger) joint
108Finger joint polymer constrained prosthesisit is a registrations of the regulatory approval for medical devices that intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
109hip joint metal/composite semi-constrained cemented prosthesisA hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint
110Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousit is a  registration of the regulatory approval for medical devices rules that Intended to be implanted to replace a hip joint
111Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.it is a  regulatory approval for the medical devices rules in india that Intended to be implanted to replace a hip joint
112A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee jointIntended to be implanted to replace part of a knee joint
113Shoulder joint metal/metal or metal/polymer constrainedIntended to be implanted to replace a shoulder joint
114Wrist joint carpal lunate polymer prosthesisIntended to be implanted to replace the carpal lunate bone of the wrist.
115Wrist joint metal/polymer semi-constrained cemented prosthesisIntended to be implanted to replace a wrist joint.
116Wrist joint metal constrained cemented prosthesisIntended to be implanted to replace a wrist joint
117Wrist joint polymer constrained prosthesisIntended to be implanted to replace a wrist joint
118Wrist joint carpal trapezium polymer prosthesisIntended to be implanted to replace the carpal trapezium bone of the wrist
119Wrist joint carpal scaphoid medical devices polymer prosthesisImplanted to replace the carpal scaphoid bone of the wrist.
120Toe joint phalangeal (hemi-toe) polymer prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace the base of the proximal phalanx of the toe.
121Toe joint polymer constrained prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace the first metatarsophalangeal (big toe) joint
122Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
123Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a shoulder joint
124Shoulder joint metal/polymer/metal non constrained or semi-constrained porous-coated uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace a shoulder joint
125Shoulder joint metal/polymer semi-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace a shoulder joint
126shoulder joint metal/polymer non-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is to replace a shoulder joint
127Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
128Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace the retropatellar articular surface of the patellofemoral joint
129knee joint femoral (hemi-knee) metallic uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
130knee joint patellofemorotibial metal/polymerRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace regulatory approval for the medical devices rules a knee joint
131Knee joint patello femorotibial polymer/metal/polymer semi-constrained cemented prosthesis.Regulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace a knee joint
132Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace a knee join
133knee joint patellofemoral polymer/metal semi-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia
134Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
135Knee joint femorotibial metal/polymer semi-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
136Knee joint femorotibial metal/polymer non-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
137Knee joint femorotibial metal/polymer constrained cemented prosthesisKnee joint femorotibial metal/polymer constrained cemented prosthesis
138Knee joint femorotibial metal/polymer constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
139Knee joint femorotibial metal/composite semi-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint.
140Knee joint femorotibial metal/composite non-constrained cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace part of a knee joint
141Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.Regulations for the registration and regulatory approval of medical devices rules in india, which is implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
142Spinal intervertebral body fixation orthosisThe device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
143Spinal interlaminal fixation orthosisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted made of an alloy, which consists of various hooks and a posteriorly placed compression or distraction rod. The device is used primarily in the treatment of scoliosis
144Resorbable calcium salt bone void filler deviceA resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
145Smooth or threaded metallic bone fixation fastenerIt may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
146Intrastromal corneal ringA small device implanted in the eye to correct vision.
147Injectable fillersInjectable filler (injectable cosmetic filler, injectable facial filler) is a soft tissue filler injected into the skin to help fill in facial wrinkles, restoring a smoother appearance
148Tracheal prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to restore the structure and/or function of the trachea or tracheal bronchial tree
149Polytetrafluoroethylene with carbon fibers composite implant materialRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear.
150Chin prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended implanted to augment or reconstruct the chin
151Ear prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is implanted to reconstruct the external ear
152Nose prosthesis Regulations for the registration and regulatory approval of medical devices rules in india, which is implanted to augment or reconstruct the nasal dorsum.
153Esophageal prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to restore the structure and/or function of the esophagus
154Fixation, non-absorbable for pelvic useAttaching suture or stapling ligaments of the pelvic floor.
155Sacroiliac joint fixationThe sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region.
156Tissue adhesive for the topical useMedical devices that are intended for topical closure of surgical incisions including laparoscopic incisions and simple traumatic lacerations.
157Dental adhesive systemRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to use as dental cement, etchant, primer
1Class DRadiofrequency Ablation DeviceRegulations for the registration and regulatory approval of medical devices rules in india, which is a part of the electrical conduction system of the heart, tumour or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current
2Percutaneous Conduction Tissue AblationClinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
3Suction Ablation Catheter SystemRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for use in inactivating portions of the heart’s conduction system to prevent abnormal heartbeat rates, comprises a tubular body having an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.
4Fiberoptic Oximeter CatheterRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for monitoring the balance between oxygen delivery and consumption at the bedside
5Cardiac Catherization KitCardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography
6Balloon for Cerebrovascular OcclusionBalloon used to treat Blockage or closing of Cerebrovascular vessels/carotid arteries
7Intra-Aortic System Balloon and ControlIt is a mechanical medical devices that increases myocardial oxygen perfusion while at the same time increasing cardiac output
8Peripheral, Transluminal Angioplasty CatheterA catheter for treating peripheral vascular diseases
9Cardiac Thermodilution CatheterA catheter used in thermodilution for introduction of the cold liquid indicator into the cardiovascular system.
10Cardiovascular CatheterIt is a medical device in which a thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
11Cerebrospinal CatheterA medical devices used for treatment or prevention of cranial/spinal cerebrospinal fluid fistula
12Atherectomy Coronary CatheterRegulations for the registration and regulatory approval of medical devices rules in india, which is intended a catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and endarterectomy
13Electrode Recording Probe, Electrode Recording CatheterA cardiac catheter containing one or more electrodes; it may be used to pace the heart or to deliver high energy shocks.
14Embolectomy Catheterindicated for the removal of fresh, soft emboli and
thrombi from vessels in the arterial system
15Flow Directed CatheterUsed for venous sampling and pressure monitoring.
16Ultrasonic imaging CatheterRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for ultrasound examination of peripheral pathology only
17Intraaortic Balloon CatheterRegulations for the registration and regulatory approval of medical devices rules in india, which is indicated for use in patients undergoing cardiopulmonary bypass.
18Intracardiac Mapping, High Density Array CatheterA high density array catheter once used in the right atrium to map and diagnosis complex arrhythmias and assess the effectiveness of ablation treatment.
19Intravascular Occluding CatheterRegulations for the registration and regulatory approval of medical devices rules in india, which is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms of intracranial blood vessels
20Intravascular Diagnostic CatheterUsed to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
21Occlusion CatheterInsertion of a device or develop at any time during the course of intravenous (IV) therapy.
22Percutaneous CatheterA needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen (pathway) of the needle.
23Perfusion CatheterPerfusion catheter allowing localised perfusion of drugs not only into the vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention. –
24Pericardium Drainage CatheterCatheter drainage of the pericardium
25Atherectomy Peripheral Catheter Regulations for the registration and regulatory approval of medical devices rules in india, which is intended for use in atherectomy of the peripheral vasculature.
26Septostomy CatheterUsed to enlarge interatrial openings
27Thrombectomy CatheterThrombectomy catheter is specifically designed to treat deep vein thrombosis (DVT) in large-diameter upper and lower peripheral veins.
28Transluminal, Coronary Angioplasty, Percutaneous CatheterThe catheter is placed in the opening or ostium of one the coronary arteries
29Pacemaker Lead
(Catheter)
A catheter that is inserted near your collarbone or through your leg (groin) artery.
30Central Nervous System Shunt including Neurological catheters and other ComponentsIt is a medical devices or combination of medical devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume.
31Embolic Protection DeviceEmbolic protection devices are used to capture and remove debris that becomes dislodged during an interventional procedure
32Artificial Embolization DeviceUsed for the treatment of unresectable/inoperable hypervascularized tumours.
33Absorable Hemostatic Collagen BasedAn absorbable haemostatic agent or dressing of medical devices is intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
34Detachable coilsRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for endovascular embolization of the intracranial aneurysms. Also intended for the embolization of other neurovascular abnormalities
35Pulmonary Artery BandRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to reduce excessive pulmonary blood flow and protect the pulmonary vasculature from hypertrophy and irreversible (fixed) pulmonary hypertension
36Vascular clipA small titanium or polyglycolic acid vessel clamp used to occlude blood vessels or to perform vascular anastomoses.
37Vena cava clipImplanted extravascular medical devices are designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.
38Vascular graft/occluders/Cardiac PatchesIntended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
39Vascular embolization deviceIt is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
40Cardiovascular prosthetic devicesAn intra-cardiac patch or pledgete which is a medical devices  placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
41Intra-aortic balloon and control systemRegulations for the registration and regulatory approval of medical devices rules in india, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies.
42Ventricular bypass (assistive)A ventricular bypass (assistive) device is a medical device that assists the left or right ventricle in maintaining circulatory blood flow.
43Heart valveRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to perform the function of any of the heart’s natural valves.
44Total ossicular replacement prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.
45Eye sphere implantAn eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
46KeratoprosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye.
47Bone heterograftRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
48Total temporomandibular joint registration of the prosthesis Regulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
49Glenoid fossa prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
50Mandibular condyle prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
51An interarticular disc prosthesisThe registration and regulatory approval of the medical devices in india are Intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
52Implantable cardiac pacemaker including accessoriesAn implantable pacemaker pulse generator is a medical device that generates a periodic electrical pulse to stimulate the heart.
53Implantable cardioverter defibrillatorAn implantable cardioverter defibrillator (ICD) is used to treat irregular heartbeats called arrhythmias.
54Implantable cerebral stimulatorsAn implanted cerebellar stimulator is a medical devices used to stimulate electrically a patient’s cerebellar cortex related disorders.
55Implanted intracerebral/subcortical stimulator for pain reliefAn implanted intracerebral/subcortical stimulator used to subsurface areas of a patient’s brain to treat severe intractable pain.
56Implanted spinal cord stimulator for bladder evacuationIt is used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters.
57Implanted neuromuscular stimulatorIt provides electrical stimulation to a patient’s nerve to cause muscles in the affecting area of the body to contract, thus improving condition of a patient with a paralyzed organ.
58Implantable Diaphragmatic stimulatorRegulations for the registration and regulatory approval of medical devices rules in india, which provides electrical stimulation of  a patient’s phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease.
59Implanted peripheral nerve stimulator for pain reliefIt is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain.
60Implanted spinal cord stimulatorRegulations for the registration and regulatory approval of medical devices rules in india, which is used to stimulate electrically a patient’s spinal cord to relieve severe intractable pain.
61A carotid sinus nerve stimulatorImplantable medical devices used to decrease arterial pressure by stimulating Hering’s nerve at the carotid sinus.
62A testicular prosthesisA testicular prosthesis is an implanted medical device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
63Implantable Infusion pumpAn implantable infusion pump (IIP) is intended to provide long-term continuous or intermittent drug infusion
64Coronary stentA coronary stent is a tube-shaped medical devices placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
65Drug eluting stentStent, coronary, drug-eluting – a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
66Bioresorbable Vascular Scaffold (BVS) SystemAn absorbable stent which is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
67Implanted electrical urinary continence deviceRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.
68Haemo-Dialyzer SystemThe dialyzer is a medical device intended for the treatment of chronic and acute renal failure by hemodialysis.
69Cochlear implantA cochlear implant is an implanted electronic hearing medical device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
70Retinal implantThe retinal implant is meant to partially restore useful vision to people who have lost their vision due to degenerative eye conditions
71Intervertebral body fusion deviceRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion
72hip joint metal constrained cemented or uncemented prosthesisA hip joint metal constrained cemented or uncemented prosthesis is a medical devices intended to be implanted to replace a hip joint
73Hip joint metal/polymer constrained cemented or uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to have a hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
74Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.Regulations for the registration and regulatory approval of medical devices rules in india, that is a prosthesis intended to be implanted to replace a hip joint
75hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a hip joint
76Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a hip joint
77hip joint metal constrained cemented or uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a hip joint
78Hip joint metal/polymer constrained cemented or uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a hip joint
79Hip joint femoral (hemi-hip) metallic resurfacing prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a portion of the hip joint
80A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace the head and neck of the femur
81A hip joint femoral (hemi-hip) trunnion-bearing Regulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace the head and neck of the femur
82Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.Regulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace the head and neck of the femur
83A hip joint (hemi-hip) acetabular metal cemented prosthesisRegulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a portion of the hip joint
84Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.Regulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace a portion of the hip joint
85Intra Ocular lenses (IOL)Regulations for the registration and regulatory approval of medical devices rules in india, which is intended to be implanted to replace the natural lens of an eye.
86IOL multifocal
87IOL tori optic
88IOL accommodative
89IOL iris reconstruction
90Tissue adhesive for non-topical usForeRegulations for the registration and regulatory approval of medical devices rules in india, which is intended for use in adhesion of internal tissues and vessels, for example; adhesives used in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery.