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 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 list of medical devices along with their risk class

Class A Medical Devices:

S.NoNotified Device Category/DrugDevice NameRisk ClassGeneral Intended Use
1CathetersNasopharyngeal Catheter / NasopharyngealClass AA catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
2Disposable Perfusion SetsY-Connector as an accessory to perfusion setsClass AIt can be used to connect to a perfusion  sets  or catheter  for infusion of contrast media etc.
3Surgical DressingsSurgical DressingsClass ADressing aerosol,  non-adherent, dressing, periodontal, kit, dressing pad, dressing.
4Surgical DressingsUmbilical occlusion deviceClass AThese devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
5Surgical DressingsBolster SutureClass ANon-latex plastic bolsters are used to hinder  pressure of any temporary suture against the body during surgery.
6Surgical DressingsAlcohol SwabsClass AIt is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing and allowing drying and will disinfect needless access sites prior to use.

Class B Medical Devices:

S.NoNotified Device Category/DrugDevice NameRisk ClassGeneral Intended Use
1CathetersFiberoptic Oximeter CatheterClass BIntended for monitoring the balance between oxygen  delivery and consumption at the bedside
2CathetersA-V  Shunt or Fistula AdapterClass BA blood access device and accessories is a device intended to provide access to a patient’s blood for haemodialysis or other chronic uses.
3CathetersTranscervical(Aminoscope) Endoscope and accessoriesClass BIt 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.
4CathetersForceps, endoscopicClass BGrasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
5CathetersVessel Dialator for percutaneous CatheterizationClass BA  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.
6CathetersTracheobronchial Suction CatheterClass BClearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
7CathetersCervical DrainClass BThe  device  is  used  to  avoid postoperative wound and respiratory complications such as excessive edema,  hematoma,  infection, re-intubation, delayed extubation, or respiratory distress
8CathetersRectal BalloonClass BReducing 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.
9CathetersBiliary Stone Retrieval BasketClass BIntend to extract stones in an antegrade fashion through an ampullary previously treated sphincterotomy or less commonly with balloon dilation
10CathetersTracheostomy Tube/Tracheal TubeClass BA breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation
11CathetersVial AdapterClass BIt  is  indicated  to  allow  multiple needleless access to  injection medication  vials  for  transfer  or withdrawal of fluids from the vial.
12CathetersSuprapubic, non -disposable CannulaClass Ban emergency measure for the relief of acute urinary retention or condition which require  temporary and permanent drainage of bladder.
13CathetersEsophageal obturatorClass BInserted 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.
14CathetersBalloon Catheter for Retinal ReattachmentClass BAn instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball.
15CathetersGastric, Colonic, etc.) Irrigation and Aspiration CatheterClass BUsed  for  instilling  fluids  into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
16CathetersSuction Tip  and CatheterClass BSuction Catheters feature a whistle tip and a thumb  control port  for precise and accurate suctioning.
17CathetersAngiographic CatheterClass BDesigned to provide a  pathway for delivering contrast  media  to selected sites in  the device vascular system including the carotid arteries.
18CathetersArterial CatheterClass BIntended to be used in conjunction with steerable guidewires in order to access discrete regions  of the  coronary and peripheral arterial vasculature.
19CathetersBalloon Type CatheterClass B“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.
20CathetersBalloon Dialation Vessel CatheterClass BIntended  for  use  in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
21CathetersBartholin Gland CatheterClass BCatheter is used for the treatmenti of abscesses and cysts of the Hartholin gland.
22CathetersBronchography CatheterClass BIntended to  deliver  therapeutic  and diagnostic agents that are indicated or labeled for airway, tracheal or
23CathetersCholangiography CatheterClass BDiagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures.
24CathetersAnesthetic Conduction CatheterClass BAn anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia
25CathetersContinuous Flush CatheterClass BIntended for the controlled and selective infusion of
26CathetersContinous Irrigation CatheterClass BIntended to be used to introduce fluids into body cavities other  than blood vessels, drain fluids from body cavities, or evaluate certain   physiologic conditions.
27CathetersCoude CathetersClass BIt is a urinary catheter, It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
28CathetersDepezzer CatheterClass BA tubular, flexible instrument, passed through body channels for withdrawal of fluids from a body cavity.
29CathetersDouble Female Urethrographic CatheterClass BIntended 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.
30CathetersEpidural CatheterClass BEpidural catheter is a very thin, flexible tube that is implanted into spine
31CathetersEsophageal Balloon CatheterClass Bintended for use in adult and adolescent populations
32CathetersEustachian CatheterClass BIt is used to test Eustachian tube patency
33CathetersGuiding CatheterClass BThe guide catheter provides support for device advancement .
34CathetersHaemodialysis CatheterClass BA catheter used for exchanging blood to and from the haemodialysis machine from the patient.
35CathetersIntramuscular Pressure Monitoring CatheterClass BA modified fibre optic  transducer-tipped catheter system for measuring intramuscular pressures during exercise was determined.
36CathetersIntravenous CatheterClass BA 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
37CathetersJejunostomy CatheterClass BUsed for intraoperative feeding jejunostomy
38CathetersMultiple Lumen CatheterClass BIntended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.
39CathetersNasal Oxygen CatheterClass BIt is a device used to deliver supplemental  oxygen or increased airflow to a patient or person in need of respiratory help.
40CathetersNephrostomy CatheterClass BA nephrostomy is a tube that’s used to drain urine from a kidney into a bag outside the body.
41CathetersPeritoneal Dialysis CatheterClass BThat allows dialysis fluid to enter the abdominal cavity, dwell  inside for a while, and then drain back out again
42CathetersRadiographic (Non Vascular) CatheterClass BInterventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
43CathetersRectal CatheterClass BIt is inserted into the rectum in order to relieve flatulence which has been chronic  and  which  has  not  been alleviated by other methods.
44CathetersRetention Type CatheterClass BThis type of catheter is placed into the bladder and secured there for a period of time.
45CathetersRetention Type Balloon CatheterClass BIt 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
46CathetersSalpngography CatheterClass BUsed for injection of contrast medium into the fallopian tube(s) for selective salpingography.
47CathetersSingle Needle Hemodialysis Catheter/Blood linesClass BThe single-needle dialysis, in which case only one  cannula  or a single-lumen catheter is used  to access the blood
48CathetersStraight CatheterClass BIt is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection
49CathetersSubclavian CatheterClass BCatheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein)
50CathetersSuprapubic  CatheterClass BA suprapubic catheter is a thin, sterile tube used to drain urine from bladder.
51CathetersUmblical Artery CatheterClass BUmbilical 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
52CathetersUpper Urinary Tract CatheterClass BThe  catheter to  the bladder and subsequently to the upper urinary tract
53CathetersUrethral Catheter/Nelaton Catheter/ Foley CatheterClass BA long, small gauge catheter designed for insertion directly into a ureter, either through the urethra andbladder or posteriorly via the kidney.
54CathetersUrethrographic Male CatheterClass BA catheter used to pass into a man’s bladder.
55CathetersChorionic Villus Sampling CatheterClass BAn ultrasound guides  a thin catheter through the cervix to your placenta. The chorionic villi cells are gently suctioned into the catheter.
56CathetersSclerotherapy Needle/ CatheterClass BSclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR)
57CathetersWater  Jet Renal CatheterClass BA 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.
58CathetersOximetry catheters, Oximetry Paceport catheterClass BIt is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring,  cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions.
59CathetersFlow Directed CatheterClass BUsed for venous sampling and pressure monitoring.
60CathetersUltrasonic maging CatheterClass Bintended for ultrasound examination of peripheral pathology only
61CathetersEndoscopic Ligation DevicesClass BIt is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
62CathetersDialysate Tubing and ConnectorClass BA tubing connector adapted  for peritoneal dialysis  connections between tubing sets and containers of dialysate
63CathetersUrinary Drainage UnitClass BA closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag
64CathetersIn-Vitro Fertilization/ Embryo Transfer CatheterClass BA cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient
65CathetersSclerotherapy Needle/ CatheterClass BIt is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
66CathetersFluid Delivery tubingClass BTube used to deliver fluid in body
67CathetersColon TubeClass BColon 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).
68CathetersConnecting TubeClass BUsed to provide connection to a drainage bag.
69CathetersDecompression TubeClass BDecompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
70CathetersDouble Lumen for intestinal Decompression and/or Intubation TubeClass BTracheal 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.
71CathetersClosed Wound Drainage Tube or SystemClass BA 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.
72CathetersOesophageal Blakemore TubeClass BIt is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
73CathetersOesophageal Sengtaken TubeClass BIt is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone
74CathetersFeeding TubeClass BA 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
75CathetersGastro- Enterostomy TubeClass BTube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
76CathetersGastrointestinal TubeClass BA gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach
77CathetersHeart-Lung Bypass Unit TubeClass BA tube will be placed in your heart to drain blood to the machine.
78CathetersLevine TubeClass BUsed for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
79CathetersNasoGastric Tube/ Ryles TubeClass BIt 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
80CathetersNephrostomy TubeClass BThe nephrostomy tube drains  urine from kidney into a collecting bag outside the body.
81CathetersOrthodontic TubeClass BAn orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bumpers, facebows and other devices used to move the teeth.
82CathetersRectal TubeClass BA rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence .
83CathetersStomach Evaculator(Gastric Lavage) TubeClass BPassage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
84CathetersTonsil Suction TubeClass BUsed to suck out stones in tonsils
85CathetersTracheal (Endotracheal) TubeClass BInserts 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.
86CathetersClosed Suction SystemClass BIt  is  intended  for  endotracheal suctioning to provide a patient airway by removing excess fluids, secretions, exudates and transudate  through the artificial airway.
87CathetersEndolymphatic Shunt TubeClass BDuring a surgical procedure in which it is placed in   the membranous labyrinth of the inner ear to drain excess fluid.
88CathetersOrthodontic Guide WireClass BA 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.
89DisinfectantsDisinfectantsClass BAn 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.
90Disposable Hypodermic NeedlesAspiration NeedleClass BUsed for either laparoscopic aspiration or injection
91Disposable Hypodermic NeedlesAspiration and Injection NeedleClass BA 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.
92Disposable Hypodermic NeedlesInsulin Needles/Pen Needles for insulinClass BUsed to inject insulin for the treatment of diabetes.
93Disposable Hypodermic NeedlesMedication InjectorClass BA subcutaneous injection is a method of administering medication.
94Disposable Hypodermic NeedlesBiopsy Needle KitClass BA set of neurosurgical instruments designed  to allow multiple biopsies from one or more targets in one trajectory
95Disposable Hypodermic NeedlesAngiographic NeedleClass BAngiographic needle has a unique hub design with an ergonomic feel and a black  triangle indicator to orient the bevel.
96Disposable Hypodermic NeedlesMammary Biopsy NeedleClass BThe growth sample is suctioned out through  a needle or cut out using a surgical procedure
97Disposable Hypodermic NeedlesBlood  Collecting NeedleClass BIntended to be used with evacuated blood collection tube for collection of
venous blood.
98Disposable Hypodermic NeedlesBone Marrow NeedleClass BNeedle inserted in Bone Marrow to collect sample
99Disposable Hypodermic NeedlesGynaecological Cerclage NeedleClass BIt is a loop like instrument used to suture the cervix.
100Disposable Hypodermic NeedlesCholangiography NeedleClass BThe aspirating needle is passed through the patient’s skin and liver tissue until the tippenetrates one of the hepatic ducts
101Disposable Hypodermic NeedlesAnaesthetic Conduction NeedleClass BAn anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia
102Disposable Hypodermic NeedlesEmergency Airway NeedleClass BEmergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
103Disposable Hypodermic NeedlesEndoscopic NeedleClass BUsed to  sample  targeted submucosal gastrointestinal lesions through the accessory  channel of an ultrasound endoscope.
104Disposable Hypodermic NeedlesFistula NeedleClass BTo connect blood lines with the blood vessels through needles when dialysis is carried out
105Disposable Hypodermic NeedlesEpidural NeedleClass BIntended  for transient delivery of anasthetics  to  provide  regional anesthesia or to facilitate placement of an epidural catheter
106Disposable Hypodermic NeedlesGastro-Urology NeedleClass BIntended for gastroenterology biopsy
107Disposable Hypodermic NeedlesSingle Lumen Hypodermic NeedleClass BA 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.
108Disposable Hypodermic NeedlesNeurosurgical Suture NeedleClass BA needle  used in suturing during neurosurgical procedures or in the repair of nervous tissue.
109Disposable Hypodermic NeedlesOocyte Aspiration NeedleClass BMission  to collect the  maximum amount of undamaged oocytes in  a short time as possible.
110Disposable Hypodermic NeedlesPneumoperitoneum Simple NeedleClass BInserting a Veress needle through the abdominal wall inside the  peritoneal cavity.
111Disposable Hypodermic NeedlesPrefillable Glass Barrel with needleClass BIntended   for  the  automatic self-administration of drugs and biologics from standard Glass Barrel.
112Disposable Hypodermic SyringesAspiration SyringeClass BUsed for either laparoscopic aspiration or injection
113Disposable Hypodermic SyringesIrrigating SyringesClass Bcleaning debris away from the area the dentist is working on
114Disposable Hypodermic SyringesInsulin SyringesClass BUsed to inject insulin for the treatment of diabetes.
115Disposable Hypodermic SyringesAuto  Disable Syringe for single useClass BIntend to inject fluids into or withdraw fluids from the body.
116Disposable Hypodermic SyringesTraditional single use syringe without safety  feature (Sterile hypodermic syringes for single use)Class BIntend to inject fluids into or withdraw fluids from the body.
117Disposable Hypodermic SyringesAuto-disable (AD) syringes   for immunizationClass BIntend to inject fluids into or withdraw fluids from the body.
118Disposable Hypodermic SyringesRe use Prevention (RUP)  syringes for therapeutic injections (Syringes with   re-use prevention feature)Class BIntend to inject fluids into or withdraw fluids from the body.
119Disposable Hypodermic SyringesSharps  Injury Protection (SIP) Plastic needle shield to be added to a syringeClass BIntend to inject fluids into or withdraw fluids from the body.
120Disposable Perfusion SetsSharps  Injury Blood Administration kitsClass BIt is used to administer blood from a container to a patient’s vascular system through  a needle or catheter inserted into a vein
121Disposable Perfusion SetsMeasured Volume IV SetClass BIt  is  intended  for  use  in  the administration  of fluids  from  a container into the patient’s vascular system  through  a  vascular  access device.
122Disposable Perfusion SetsTransfusion or Perfusion sets for single useClass BTransfusion Set is used to administer blood/drugs to  a patient’s vascular system through a needle or catheter inserted into a vein.
123Disposable Perfusion SetsManifoldsClass BIndicated for fluid flow  directional control and for providing access port/ports  for  administration  of  a solution.
124Disposable Perfusion Sets3 way stop cock as an accessory to perfusion setsClass BIt is indicated for fluid flow directional control and for providing access port for  administration of solution, withdrawal of fluid and pressure monitoring
125Disposable Perfusion SetsI V Flow regulatorClass BAn IV system and administration device offering precision care and consistent delivery.
126Disposable Perfusion SetsExtension SetsClass BExtension sets are sterile  devices for single use only. They are intended to be used as part of a system for the infusion of fluids/medications in medical applications.
127IV CannulaeIntravenous CannulaClass BThe 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.
128IV CannulaeArterial CannulaClass BInserted 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.
129IV CannulaeCoronary Artery CannulaClass BCannulation technique for left-sided coronary artery surgery.
130IV CannulaeHemodialysis CannulaClass BAllowing 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.
131IV CannulaeVena Cava CannulaClass BInserted into Vena Cava, taking deoxygenated blood to heart.
132IV CannulaeVenous CannulaClass BIt 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.
133IV CannulaeVentricular CannulaClass BFor use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
134IV CannulaeCannulact or Lymph DuctClass BA lymph  duct is a great lymphatic vessel that empties lymph into one of the subclavian veins
135Orthopaedic ImplantsIntra Osseous Fixation WireClass BStabilization of fractured bony parts by direct fixation to one another with surgical wires
136Orthopaedic ImplantsBone WireClass BIntended to be used for bone stabilization in the hand and wrist.
137Orthopaedic ImplantsBone capClass BIntended to be implanted to cover the end of a bone.
138Orthopaedic ImplantsPlates, clipersScrewsClass Brigid, limb brace, lumbar, lumbo-sacral, rib fracture, sacroiliac, thoracic oethosis.
139Scalp Vein SetScalp Vein SetClass BIntended to be used for insertion into the patient’s vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
140Surgical DressingsSurgical StaplesClass BSurgical       staples are specialized staples used  in  surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
141Surgical DressingsSurgical DressingsClass BDressing-gel,  dressing-  permeable, moisture  dressing, tracheostomy tube dressing,  wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
142Surgical DressingsCotton Grudges and bandagesClass BAdhesive bandages, Gauge  bandages, Pressure bandages, Traction bandages, Medical Absorbent (fiber) bandages.
143Surgical DressingsSterile DrapesClass BIt is intended for use  during various surgeries.
144Surgical DressingsCasting tapes/Splint Rolls.Class BA prosthetic and orthotic accessory, intended  for  medical  purposes  to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
145Surgical DressingsLigature WireClass Boffer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire.
146Surgical DressingsSurgical SealantClass BFor use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
147Surgical DressingsWound Closure DeviceClass BWound Closure Devices are indicated for soft tissue approximation.

Class C Medical Device:

S.NoNotified Device Category/DrugDevice NameRisk Class                                      General Intended Use
1Ablation DeviceVein Ablation DeviceClass CIt 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
2Ablation DeviceThermal Ablation DeviceClass CDestruction 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.
3Ablation DeviceUterine balloon therapy devicesClass CSystem is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal  women  with menorrhagia (excessive bleeding) due to benign  causes for whom childbearing is complete.
4Ablation DeviceRF Conducte MR steerable electrode catheterClass CIt is intended for intracardiac ablation
5Bone CementsBone cementClass CIntended  for  use  in  arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
6Cardiac StentsBifurcation StentClass CIntended for improving the side branch luminal diameter of arterial bifurcation liaisons.
7CathetersTransabdominal (Fetoscope) Aminoscope and AccessoriesClass CIt is a device designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities
8CathetersAnaesthetic Conduction KitClass CAn 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.
9CathetersVena Cava Filter SetsClass CIt is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
10CathetersAnesthesia  conduction filterClass CA  microporous  filter  used  while administering to a patient injections of local anesthetics to  minimize particulate  (foreign   material) contamination of the injected fluid
11CathetersCentral Venous CathetersClass CIt is indicated  for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and  injection of contrast media.
12CathetersIntroducer SheathClass CIntended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
13CathetersCarotid Filter SystemClass CUsed while performing angioplasty and stenting procedures in carotid arteries.
14CathetersRETRIEVAL SNAREClass Cintended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
15CathetersHemodialysis Catheter (Long Term )Class CA 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
16CathetersPercuataneous Intravascular Long Term CatheterClass CThe device 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;
17CathetersPercutaneous Long Term   Intraspinal CatheterClass CTo conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump
18CathetersImplanted Subcutaneous Intravascular Portn& CatheterClass CThe device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood
19CathetersSubcutaneous Intraspinal Port & CatheterClass CCatheters  used  for  both  epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue
20CathetersPeripheral, Transluminal Angioplasty CatheterClass CA   catheter for treating peripheral vascular diseases
21CathetersCoronary Dilation CatheterClass CIt is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft  stenosis in patients evidencing coronary ischemia for   the   purpose   of   improving myocardial perfusion.
22CathetersDiagnostic Radiology CathetersClass CAngiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction  with routine diagnostic procedures.
23CathetersVentrricular CatheterClass CIt is used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
24CathetersBalloon Repair Kit CatheterClass CA device 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.
25CathetersMicro-catheterClass CIt 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
26CathetersImaging CatheterClass CIntended for use  with the various medical imaging consoles.
27CathetersTympanostomy TubeClass CIt 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
28CathetersAnastomosis Bypass TubeClass CIt  is  anchored  to  mucosa  and submucosa 3 centimetres proximal to a site of colocolonic anastomosis   and later spontaneously evacuated by way of the rectum.
29CathetersWireClass CAn 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
30CathetersBiliary stentsClass Cthe duodenum in conditions such as ascending cholangitis due to obstructing gallstones
31CathetersDuodenal stentsClass CDuodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions
32CathetersColonic stentClass CA 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.
33CathetersPancreatic stentClass CPancreatic duct stents are often placed in patients who have chronic pancreatitis
34CathetersPeripheral Stent SystemClass CA Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
35ContraceptivesTubal  Rings/Fallopian RingsClass CContraception devices for female sterilization
36ContraceptivesMale / Female CondomsClass CCondom with nonoxynol-9, micro- condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intra vaginal condoms etc.
37Disposable Hypodermic SyringesInjector Type actuator syringeClass CA 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.
38Disposable Perfusion SetsCustom Perfusion SystemClass CIndicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure.
39Disposable Perfusion SetsInfusion Pump or Elastomeric Infusion DeviceClass CThe Infusion Pumps intended for slow, continuous  delivery   through clinically acceptable  routes of administration such as intravenous (IV), intra-arterial (IA),  and  subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management.
40Internal Prosthetic eplacementsTissue ExpandersClass CIntended  to  be  used  in  breast reconstruction or treatment of soft tissue deformities   such as used following mastectomy or for treatment of underdeveloped breasts.
41Internal Prosthetic eplacementsBio PatchesClass CIntended for reconstruction and repair of defects of pericardium.
42Internal Prosthetic eplacementsVoice / laryngeal ProthesisClass CThe device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
43Internal Prosthetic eplacementsHearing Prosthesis SystemClass CThe prostheses are intended for partial ossicular replacement to  restore functionality to the middle ear.
44Internal Prosthetic eplacementsAnnuloplasty ringClass CAn annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment.
45Internal Prosthetic eplacementsEar, nose, and throat and facial synthetic polymer material or implantClass CIt 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.
46Internal Prosthetic eplacementsMandibular implant facial prosthesisClass CIntended to be implanted for use in the functional reconstruction of mandibular deficits.
47Internal Prosthetic eplacementsSacculotomy tack (Cody tack)Class CIntended to be implanted to relieve the symptoms of vertigo.
48Internal Prosthetic eplacementsEndolymphatic shuntClass CIntended to be implanted to relieve the symptoms of vertigo.
49Internal Prosthetic eplacementsAn endolymphatic shunt tube with valveClass CIt is a 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.
50Internal Prosthetic eplacementsFallopian tube prosthesisClass CA device designed to maintain the patency  (openness)  of the fallopian tube and is  used after  reconstructive surgery.
51Internal Prosthetic eplacementsVaginal stentClass CA device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
52Internal Prosthetic eplacementsIntramedullary fixation rodClass CIntended to  be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
53Internal Prosthetic eplacementsEndosseous dental implantClass CIntended to be surgically placed in the bone of jaw arches to provide support
for prosthetic devices, such as artificial teeth.
54Internal Prosthetic eplacementsDental implantClass CA dental implant is a surgical component that interfaces with thebone of the jaw or skull to support a dental   prosthesis such as crown, bridge, denture, facial prosthesis  or to act as an orthodontic anchor.
55Internal Prosthetic eplacementsBone grafting materialClass CIntended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
56Internal Prosthetic eplacementsPenile rigidity implantClass CA device 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
57Internal Prosthetic eplacementsArtificial Urinary Sphincters implantsClass CIt is used to prevent incontinence by occluding the urethra.
58Internal Prosthetic eplacementsImplanted mechanical/hydrau lic urinary continence deviceClass CAn implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the  application  of  continuous  or intermittent pressure to  occlude the urethra.
59Internal Prosthetic eplacementsBreast implantClass CBreast implant is used to increase the breast size.
60Internal Prosthetic eplacementsTracheal prosthesisClass CIt is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree
61Internal Prosthetic eplacementsPolymeric  Surgical MeshClass CThe  polymeric  mesh  comprises  an absorbable polymeric fibre and a non-absorbable polymeric fibre knitted together to form an interdependent, co-knit  mesh structure.
62Internal Prosthetic eplacementsEndosseous dental implant abutmentClass CIntended for use as  an aid in prosthetic rehabilitation.
63Intra Ocular LensesIntraocular lensClass CIntraocular  lens (IOL) are lens implanted in the eye used to treat cataracts or myopia
64IV CannulaeA-V Shunt CannulaClass CIt is inserted into one of  the client’s blood vessels to facilitator  repeated hemodialysis.
65Orthopaedic ImplantsCortical Fixation Implant / rigidloop Adjustable Cortical Fixation SystemClass CCortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
66Orthopaedic ImplantsIntervertebral Body Fusion Device / Fuse Spinal SystemClass CIt is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels.
67Orthopaedic ImplantsOrthopedic implant & accessoriesClass CIntended to replace a missing joint or bone or to support a damaged bone.
68Orthopaedic ImplantsPedicle screw spinal systemClass CIt is used to intended   to provide immobilization and stabilization of spinal segments
69Orthopaedic ImplantsAnkle joint metal/composite semi-constrained cemented prosthesisClass CAn ankle joint metal/composite semi-constrained cemented prosthesis  is a device intended to be implanted to replace an ankle joint.
70Orthopaedic ImplantsAnkle joint metal/polymer non-constrained cemented prosthesisClass CA device 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.
71Orthopaedic ImplantsElbow joint metal/polymer constrained cemented prosthesisClass CAn elbow joint  metal/polymer constrained cemented prosthesis  is a device intended to be implanted to replace an elbow joint.
72Orthopaedic ImplantsElbow joint metal/polymer semi-constrained cemented prosthesisClass CAn elbow joint  metal/polymer   semi-constrained cemented prosthesis  is a device intended to be implanted to replace an elbow joint
73Orthopaedic Implantselbow joint radial (hemi-elbow) polymerClass CAn 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.
74Orthopaedic ImplantsElbow joint humeral (hemi-elbow) metallic uncemented prosthesisClass CA device 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 capitulumhumeri.
75Orthopaedic Implantselbow joint humeral (hemi-elbow) metallic uncemented prosthesisClass CA device 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 capitulumhumeri.
76Orthopaedic ImplantsFinger joint metal/metal constrained uncemented prosthesis.Class CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint.
77Orthopaedic ImplantsFinger joint metal/metal
constrained cemented prosthesis.
Class CA finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint.
78Orthopaedic ImplantsFinger joint polymer constrained prosthesisClass CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
79Orthopaedic Implantship joint metal/composite semi-constrained cemented prosthesisClass CA hip joint metal/composite semi-constrained cemented prosthesis  is a two-part device  intended to be implanted to replace a hip joint.
80Orthopaedic ImplantsHip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis
Class CIntended to be implanted to replace a hip joint
81Orthopaedic ImplantsHip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.Class CIntended to be implanted to replace a hip joint
82Orthopaedic ImplantsA knee joint  femorotibial
metallic constrained cemented prosthesis is a
device intended to be implanted to replace part of a knee joint
Class CIntended to be implanted to replace part of a knee joint
83Orthopaedic ImplantsShoulder joint metal/metal or metal/polymer constrained cemented prosthesisClass CIntended to be implanted to replace a shoulder joint
84Orthopaedic ImplantsWrist joint carpal lunate polymer prosthesisClass CIntended to be implanted to replace the carpal lunate bone of the wrist.
85Orthopaedic ImplantsWrist joint metal/polymer semi-constrained cemented prosthesisClass CIntended to be implanted to replace a wrist joint.
86Orthopaedic ImplantsWrist joint metal constrained cemented prosthesis.Class CIntended to be implanted to replace a wrist joint.
87Orthopaedic ImplantsWrist joint polymer constrained prosthesisClass CIntended to be implanted to replace a wrist joint
88Orthopaedic ImplantsWrist joint carpal trapezium polymer prosthesis.Class CIntended to be implanted to replace the carpal trapezium bone of the wrist.
89Orthopaedic ImplantsWrist joint carpal scaphoid polymer prosthesis.Class CIntended to be implanted to replace the carpal scaphoid bone of the wrist.
90Orthopaedic ImplantsToe joint phalangeal (hemi-toe) polymer prosthesis.Class CIntended to be implanted to replace the base of the proximal phalanx of the toe.
91Orthopaedic ImplantsToe joint polymer constrained prosthesisClass CIntended to be implanted to replace the first metatarsophalangeal (big toe) joint.
92Orthopaedic ImplantsShoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.Class CA  shoulder joint  humeral (hemi-shoulder) metallic uncemented prosthesis.
93Orthopaedic ImplantsShoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.Class CA  shoulder joint  humeral (hemi-shoulder) metallic uncemented prosthesis.
94Orthopaedic ImplantsShoulder joint glenoid (hemi-shoulder) metallic cemented prosthesisClass CIt is intended to be implanted to replace part of a shoulder joint
95Orthopaedic ImplantsShoulder joint metal/polymer/metal nonconstrained or semi- constrained porous-coated uncemented
prosthesis
Class CIt is a device intended to be implanted to replace a shoulder joint.
96Orthopaedic ImplantsShoulder joint metal/polymer semi-constrained cemented prosthesisClass CIntended to be implanted to replace a shoulder joint
97Orthopaedic Implantsshoulder joint metal/polymer non-constrained cemented prosthesis.Class CIntended to be implanted to replace a shoulder joint.
98Orthopaedic ImplantsKnee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.Class CIntended to be implanted to replace part of a knee joint.
99Orthopaedic ImplantsKnee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.Class CIntended to be implanted to replace the retropatellar articular surface of the patellofemoral joint .
100Orthopaedic Implantsknee joint femoral (hemi-knee) metallic uncemented prosthesisClass CIntended to be implanted to replace part of a knee joint.
101Orthopaedic Implantsknee joint patellofemorotibial metal/polymer.Class CIntended to be implanted to replace a knee joint.
102Orthopaedic ImplantsKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.Class CIntended to be implanted to replace a knee joint
103Orthopaedic ImplantsKnee joint patellofemorotibial polymer/metal/metal constrained cemented
prosthesis
Class CIntended to be implanted to replace a knee join
104Orthopaedic Implantsknee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis
Class CIt is intended to be implanted to replace part of a knee joint in the treatment of primary  patellofemoral  arthritis  or chondromalacia.
105Orthopaedic ImplantsKnee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.Class CIntended to be implanted to replace part of a knee joint.
106Orthopaedic ImplantsKnee joint femorotibial metal/polymer semi-constrained cemented
prosthesis.
Class CIntended to be implanted to replace part of a knee joint.
107Orthopaedic ImplantsKnee joint femorotibial metal/polymer non-constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint.
108Orthopaedic ImplantsKnee joint femorotibial metal/polymer constrained cemented prosthesis.Class CKnee joint femorotibial metal/polymer constrained cemented prosthesis.
109Orthopaedic ImplantsKnee joint femorotibial metal/polymer constrained cemented
prosthesis.
Class CIntended to be implanted to replace part of a knee joint.
110Orthopaedic ImplantsKnee joint femorotibial
metal/composite semi-constrained cemented prosthesis.
Class CIntended to be implanted to replace part of a knee joint.
111Orthopaedic ImplantsKnee joint femorotibial metal/composite non-constrained cemented prosthesis.Class CIntended to be implanted to replace part of a knee joint.
112Orthopaedic ImplantsHip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented
prosthesis.
Class CIntended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
113Orthopaedic ImplantsSpinal intervertebral body fixation orthosisClass CThe device is used to apply force to a series of vertebrae to correct  “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
114Orthopaedic ImplantsSpinal interlaminal
fixation orthosis
Class CA device intended to  be implanted made of an  alloy, that  consists  of various hooks and a posteriorly placed compression or distraction rod. The device  is  used  primarily  in  the treatment of scoliosis.
115Orthopaedic ImplantsResorbable calcium salt bone void filler deviceClass CA resorbable calcium  saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
116Orthopaedic ImplantsSmooth or threaded metallic bone fixation fastenerClass CIt 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.
117Orthopaedic ImplantsSacroiliac joint fixationClass CThe sacroiliac joints fixation may serve as protective mechanism  for the lumbosacral region.
118Surgical DressingsWound Dressings/Bacterio static Wound DressingsClass CIncludes Beads, Hydrophilics For Wound Exudate Absorption for wound care.
119Surgical DressingsHaemostatic  Gelatine Sponge /HaemostatClass CIntended for the control  of surface bleeding from vascular access sites and percutaneous catheters or tubes
120Surgical DressingsSurgical DressingsClass CAn absorbable haemostatic agent or dressing is  a device intended to produce haemostasis by accelerating the clotting process of  blood.  It is absorbable.
121Surgical DressingsSuture Non Absorable Synthetic.Class CNon-absorbable suture is comprised of surgical steel as well as synthetic non- absorbable sutures for use in general soft tissue approximation and ligation.
122Surgical DressingsSuture AbsorableClass CThe device is intended  for use in general soft tissue approximation and ligation.
123Surgical DressingsEndovascular suturing systemClass CIt is a medical device  intended to provide fixation and sealing between an endovascular  graft and the native artery.
124Surgical DressingsFixation, non-absorbable for pelvic use.Class CAttaching suture or stapling ligaments of the pelvic floor.
125Surgical DressingsTissue adhesive for the topical useClass CIntended for topical closure of surgical incisions including  laparoscopic incisions and simple traumatic lacerations.

Class D Medical Devices

S.NoNotified Device Category/DrugDevice NameRisk ClassGeneral Intended Use
1Ablation DeviceRadiofrequency Ablation DeviceClass DA medical procedure in which 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
2Ablation DevicePercutaneous Conduction Tissue AblationClass DClinical  applications using hollow needles  (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
3Ablation DeviceSuction Ablation Catheter SystemClass DIntended  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.
4Cardiac StentsCoronary stentClass DA coronary stent is  a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
5Cardiac StentsBioresorbable Vascular Scaffold (BVS) SystemClass DAn absorbable stent which   is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
6CathetersAngiographic Guide  WireClass DIt 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.
7CathetersCardiac Catherization KitClass DCardiac catheterization  is a general term for a group of procedures that are performed using this method, such as coronary  angiography and left ventricle angiography
8CathetersBalloon for Cerebrovascular OcclusionClass DBalloon used to treat Blockage closing  of  Cerebrovascular vessels/carotid arteries
9CathetersIntra-Aortic System Balloon and ControlClass DIt is a mechanical device that increases myocardial oxygen perfusion while at the same time increasing cardiac output
10CathetersEmbolic Filter systemClass DIt is indicated for general use as a guidewire and embolic protection system during angioplasty and  stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
11CathetersRETRIEVAL SNAREClass Dintended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral system and the extra cranial neurovascular anatomy.
12CathetersCardiac Thermodilution CatheterClass DA catheter used in thermodilution for in troduction of the cold liquid indicator into thecardiovascular system or for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or  wedge  pressure monitoring, cardiac output  determination, and for infusing solutions.
13CathetersCardiovascular CatheterClass DA thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
14CathetersCerebrospinal CatheterClass DFor treatment or prevention of cranial/spinal cerebrospinal fluid fistula.
15CathetersAtherectomy  Coronary CatheterClass DA catheter containing a rotating cutter and a collecting chamber for debris, used   for  atherectomy and
endarterectomy.
16CathetersElectrode Recording Probe, Electrode Recording CatheterClass DA cardiac catheter  containing one or more electrodes; it may be used to pace the heart or to deliver  high energy shocks.
17CathetersEmbolectomy CatheterClass Dindicated for the removal of fresh, soft emboli and
18CathetersIntraaortic Balloon CatheterClass DIt is indicated for use in patients undergoing cardiopulmonary bypass.
19CathetersIntracardiac Mapping, High Density Array CatheterClass DA high density array catheter once used in the   right atrium to map and diagnosis complexarrhythmias and assess the effectiveness of ablation treatment.
20CathetersIntravascular Occluding CatheterClass DIt 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
21CathetersIntravascular Diagnostic CatheterClass DUsed to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels
22CathetersOcclusion CatheterClass DInsertion of a device or develop at any time during the course of intravenous (IV) therapy.
23CathetersPercutaneous CatheterClass DA needle catheter getting access to a blood  vessel, followed by  the introduction of a wire through the lumen (pathway) of the needle.
24CathetersPerfusion CatheterClass DPerfusion 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.
25CathetersPericardium Drainage CatheterClass DCatheter drainage of the pericardium
26CathetersAtherectomy Peripheral CatheterClass DIntended for use in atherectomy of the peripheral vasculature.
27CathetersSeptostomy CatheterClass DUsed to enlarge interatrial openings
28CathetersThrombectomy CatheterClass DThrombectomy catheter is specifically designed to treat deep vein thrombosis (DVT) in large-diameter upper and lower peripheral veins.
29CathetersTransluminal, Coronary Angioplasty, Percutaneous CatheterClass DThe catheter is placed in the opening or ostium of one the coronary arteries
30CathetersCentral Nervous System Shunt including Neurological catheters and other ComponentsClass DIt is a device or combination of 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.
31CathetersIntra-aortic balloon and control systemClass DIt is a medical device which is placed in the aorta to improve cardiovascular functioningduringcertain   life-threatening emergencies.
32CathetersVentricular bypass (assistive)Class DA ventricular bypass (assistive) device is a device that assists the left or right ventricle in maintaining circulatory blood flow.
33CathetersCatheter Guide WireClass DIt is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal  coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel
34CathetersCatheter GuideClass DIt is intended to facilitate the placement of balloon ilatation catheters during percutaneous transluminal coronary
angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel.
35CathetersCarotid Stent SystemClass DIndicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
36ContraceptivesCu-TClass DIndicated for intrauterine contraception for up to 10 years.
37Drug Eluting StentsDrug eluting stentClass DStent, 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.
38Heart ValvesHeart valveClass DA device intended to perform the function of any of the heart’s natural valves.
39Internal Prosthetic eplacementsVascular graft/occluders/Car diac PatchesClass DIntended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature,  and to provide vascular access.
40Internal Prosthetic eplacementsVascular embolization deviceClass DIt is an intravascular implant intended to control  hemorrhaging due to aneurysms, certain types of tumors.
41Internal Prosthetic eplacementsCardiovascular prosthetic devicesClass DAn intra-cardiac patch  or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch  grafting, to repair tissue, and to buttress sutures.
42Internal Prosthetic eplacementsTotal ossicular replacement prosthesisClass DIt is a device intended to be implanted 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.
43Internal Prosthetic eplacementsEye sphere implantClass DAn 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.
44Internal Prosthetic eplacementsKeratoprosthesisClass DIt is a device intended  to provide a transparent optical pathway through an opacified  cornea, either intraoperatively or permanently, in an eye.
45Internal Prosthetic eplacementsBone heterograftClass DIntended to be implanted that is made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
46Internal Prosthetic eplacementsTotal temporomandibular joint prosthesisClass DIntended to be implanted in the human jaw to replace the mandibular condyle and augment the  glenoid fossa to functionally reconstruct  the temporomandibular joint.
47Internal Prosthetic eplacementsGlenoid fossa prosthesisClass DIntended  to  be  implanted  in  the temporomandibular joint to augment a glenoid fossa or to  provide an articulation surface for the head of a mandibular condyle.
48Internal Prosthetic eplacementsMandibular condyle prosthesisClass DIntended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
49Internal Prosthetic eplacementsAn interarticular disc prosthesisClass DIntended to be an interface between the natural  articulating surface of the mandibular condyle and glenoid fossa.
50Internal Prosthetic eplacementsPenile inflatable
implant
Class DA penile inflatable implant is a 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.
51Internal Prosthetic eplacementsCochlear implantClass DA cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
52Internal Prosthetic eplacementsRetinal implantClass DThe retinal implant is meant to partially restore useful vision to people who have  lost  their  vision  due  to degenerative eye conditions
53Internal Prosthetic eplacementsIntendedClass DA testicular  prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
54Internal Prosthetic eplacementsAneurysm Implant (detachable coils/clips)Class DIt is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
55Orthopaedic ImplantsIntervertebral body fusion deviceClass DThe  device  is  inserted  into  the intervertebral  body space of the cervical or lumbosacral  spine, and is intended for intervertebral body fusion
56Orthopaedic Implantship joint metal constrained cemented or uncemented prosthesisClass DA hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
57Orthopaedic ImplantsHip joint metal/polymer constrained cemented or uncemented  prosthesisClass DA hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint.
58Orthopaedic ImplantsHip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.Class DIt is a prosthesis  intended to be implanted to replace a hip joint
59Orthopaedic Implantship joint metal/metal semi-constrained, with an uncemented acetabular component,
prosthesis
Class DIntended to be implanted to replace a hip joint.
60Orthopaedic ImplantsHip joint metal/metal semi-constrained, with a
cemented acetabular component, prosthesis
Class DIntended to be implanted to replace a hip joint.
61Orthopaedic Implantship joint metal constrained cemented or
uncemented prosthesis
Class DIntended to be implanted to replace a hip joint
62Orthopaedic ImplantsHip joint metal/polymer constrained cemented or uncemented prosthesis.Class DIntended to be implanted to replace a hip joint
63Orthopaedic ImplantsHip joint femoral (hemi-hip) metallic resurfacing
prosthesis
Class DIntended to be implanted to replace a portion of the hip joint.
64Orthopaedic ImplantsA hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesisClass DIntended to be implanted to replace the head and neck of the femur
65Orthopaedic ImplantsA hip joint femoral (hemi-hip) trunnion bearing metal/polyacetal
cemented prosthesis
Class DIntended to be implanted to replace the head and neck of the femur
66Orthopaedic ImplantsHip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis.
Class DIntended to be implanted to replace the head and neck of the femur.
67Orthopaedic ImplantsA hip joint (hemi-hip) acetabular metal cemented prosthesis.Class DIntended to be implanted to replace a portion of the hip joint.
68Orthopaedic ImplantsHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.Class DIntended to be implanted to replace a portion of the hip joint.
69Orthopaedic ImplantsCervical Artificial DiscClass DCervical Artificial Disc is indicated for reconstruction of the disc.
70Surgical DressingsAbsorable Hemostatic
Based.
Class DAn absorbable haemostatic agent or dressing is  a device intended to produce haemostasis by accelerating the clotting process of  blood.  It is absorbable.
71Surgical DressingsTissue adhesive for non-topical useClass DIntended for use in adhesion of internal tissues and  vessels, for example; adhesives used in the embolization of brain arteriovenous malformation for use in ophthalmic surgery.
72Surgical DressingsIntracardiac patchClass Dintracardiac patch or pledget made of polypropylene, polyethylene terephthalate,  or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.