The Indian Health Ministry‘s newly released draft of medical device regulation in 2016 called “The Medical Device Rules 2016” has taken note of the separate laws of registration for all medical devices, In-vitro diagnostic (IVD) products.
The suggested medical device rules and regulatory updates has several measures to streamline the current standards in the medical device and IVD sector. Through this article, Morulaa HealthTech takes the opportunity to share valuable points of this new medical device rules in India for your reference and next steps. The medical device rules draft covers on all major aspects of medical device regulations in India including device definitions and classification system of medical device by CDSCO, Notified Body roles, validity of licenses and related issues.
Medical Device Rules 2016:
On 17 October, 2016, the Union Health Ministry of India published the new medical device rules draft for comments from stakeholders. The following are the key regulatory updates from the notification on medical device regulation,
1. The manufacturer shall provide evidence of previous sale in India and apply for licence within a period of 180 days (mid of December 2016) from the date may be as ought to be regulated in accordance with these rules.
2. The draft medical device rules proposes a classification of the medical devices licenced in the country based on the severity of the risks associated with them .The class based risk system for medical devices ranging from Class A (low risk) to Class D (high risk) with Class B and C occupying the middle part (low moderate risk and high moderate risk for medical devices other than IVD’s and for IVD medical devices.
3. Already notified medical devices marketed in India before in time to the starting of these rules shall continue to be marketed as before till the expiry of 18 months or the current validity of the licence from the beginning of these rules. Class A medical devices manufacturers shall not required to be licensed and these devices are self regulated in accordance with the applicable standards
4. Under the rules, State Licencing Authorities (SLAs) will hold the powers to licence and regulate the lower-risk medical devices and the Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to import and manufacture of higher-risk devices (Class C and Class D) medical devices.
5. Form MD12: An authorized agent having licence to manufacture for sale or wholesale license shall make an application for import of such medical device to the Central Licensing Authority (CDSCO) through an online portal of the Indian Central Government in Form MD12 for obtaining a registration licence. Further details about a Authorized Agents of CDSCO can be read found in – Indian Authorized Agent for Medical Device Companies.
6. Form MD13: The documents enclosed with the application for the grant the licence of medical device and manufacturing site for import
7. Rules for Granting Regulatory Licence:
i) A licence shall be granted if the medical device is having free sale certificate (FSC) issued from the national regulatory authority or any other competent authority of any of the countries (Australia, Canada, Japan, European Union Countries, or United States of America)
ii) The medical device imported from countries other than those mentioned above and falls under the classification of Class C and Class D medical devices may be granted a license after its safety and effectiveness tested through clinical investigation in India. For medical device of Class A and Class B, the regulatory license is granted through its published safety and performance data or through clinical investigation in the country of origin along with free sale certificate (FSC) from the country of origin is provided.
8. Duration of Licence:
i) A licence shall remain valid for five years from the date of its issue
ii) Before the due date fee along with a late fee calculated at the rate of 2% of the licence retention fee for every month or part of that up to 6 months and after that time the licence shall be deemed to have been cancelled.
9. In case of any change in the intended use or any major change, authorized agent shall obtain prior approval from the Licensing Authority
10. Labeling of Medical Devices:
i) Sterile devices: the sterilization date may be given as the date of the manufacture of the device
ii) Expiry date: Raw materials details such as stainless steel/titanium and supplied non-sterile, the expiry date may not be necessary
iii) Active medical device is of the nature of an instrument, equipment, an apparatus or an appliance which is used for the purpose of diagnosis or therapeutic use, requirement to bear date of expiry on the label is exempted.
iv) if the device is supplied as a sterile product, its sterile state and the sterilization method should be indicated
v) if the device is intended for clinical investigation: to overprint on the label with the words “FOR CLINICAL INVESTIGATION ONLY
vi) Medical Devices or in vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs provide affixing additional label or sticker on outer shelf pack information
vii) Medical devices on which the information cannot be printed legibly due to the small size limitations, shall include the information necessary for product identification and safety viz. information covered by clauses (a), (b)
viii) Unique device identification of the medical device shall contain device identifier and production identifier.
– Device Identifier is the global trade identifier number;
– Production Identifier is details about serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date
11. Shelf life of the medical devices:
The shelf life of the medical devices shall not exceed 60 months from the date of manufacture.
12. Import or manufacture medical device of clinical investigation & new in-vitro diagnostic products
i) Form MD24 :
– Medical device which does not have predicate medical device or has undergone clinical investigation, an application for grant of permission for such medical device after completion of its clinical investigation or clinical performance evaluation covered by in Form by an authorized agent or a manufacturer
– In case of medical device of which drugs are also a part then animal toxicology, reproduction studies, teratogenic studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and marketed in India and supported by sufficient published evidence related to safety of the drug.
ii) Form MD25:
– Permission grant to import or manufacture medical device which does not have predicate medical device or has undergone clinical investigation in Form MD25.
– the permission holder of Form MD25 shall submit the Periodic Safety Update Report to the Central Licensing Authority every 6month for the first 2years, followed annually 2 years submission
– The permission holder of Form MD25 shall submit the suspected unexpected serious adverse event within 15 days of the awareness of the event to the Central Licensing Authority.
iii) Form MD26: An application to grant permission for import or manufacture new in vitro diagnostic medical device by an authorized agent or a manufacturer itself
iv) Form MD27: grant Permission grant to import or manufacture new in vitro diagnostic medical device in Form MD27.
13. Post approval major and minor changes: is mentioned in sixth schedule
In case of injury or death occurring to the clinical investigation subject, the sponsor or his conduct of clinical investigation, shall make payment for medical management of the subject and also provide financial compensation for clinical investigation related injury or death.
14. Fees under Draft Medical Device Rules 2016 :
|License||Class||Fee||In rupees (INR) except where specified in dollars ($)|
|Import Licence for medical device||Class A||(a) one site; and||$1000|
|(b) Each distinct medical device.||$50|
|Class B||(a) one site; and||$1000|
|(b) Each distinct medical device.||$50|
|Class C and Class D||(a) one site; and||$3000|
|(b) Each distinct medical device.||$1500|
|Replacement Licence||Class A or B or C or D||Licence is defaced, damaged or lost.||$300|
|Inspection||Class A or B or C or D||Inspection of the overseas manufacturing site.||$6000|
|Import licence retention fee||Class A, B or C or D||(a) one site; and||$3000|
|Class A or Class B||(b) Each distinct medical device||$50|
|Class C or Class D||(c) Each distinct medical device||$1500|
15. The Central Government of India considered comments on proposed medical device rules update received from any person until mid of November 2016 through which industry and other interested persons submitted feedback regarding the new proposals.
Future Benefits associated with the new Medical Device Rules:
i) The new regulations will balance the system of using medical devices with International standards so as to smoothen the journey of manufacturing and importing of medical devices.
ii) National Medical Device Authority will receive authorization to promote the local medical device sector includes enforcing stringent safety standards, specific price limits, price control policy for devices like surgical instruments.
Authority for the Registration of Medical Devices:
i) Class A: Medical devices belonging to class A need not be licensed and shall remain self-regulated as per applicable standards.
ii)Class B, Class C and Class D:
-The Central Licensing Class A and Class B: The State Licensing Authority is the authority for all matters relating to these devices. It will be entitled to enforce all norms regarding the sale, manufacturer, stock, and any other practice related to Class A and Class B medical devices.
-Authority is responsible for providing the required licenses for the import and manufacture of Class C and Class D products. All queries and applications should be sent to the same.
-For companies intending to manufacture Class C or Class D medical devices along with Class A or Class B product, applications should be sent to the Central Licensing Authority.
The below table gives the set of key features of Medical Device Rules 2017:
Referred Section of the Notification
Salient features as Observed in the section
Remarks if any
Medical Device Rules 2017
|1||Chapter II, p#146 Clause 4 (1 &2).||Risk based classification – Low Risk (Class A) High Risk (Class D)||Ref. to Part II of First Schedule||– under the new medical device rules, the classification is according to patient risk in different classes (Class A, B, C & D): (i) low risk – Class A; (ii) low moderate risk- Class B; (iii) moderate high risk- Class C; (iv) high risk- Class D.|
– The manufacturers of medical devices will be required to meet risk proportionate regulation requirements as specified in the medical device rules.
– The issuance of Class A licences for medical devices on the basis of self-certification connected with a system of checks and balances for ensuring compliance is a departure from the inspection based regulatory of the government.
|2||Chapter II, p#146 Clause 4 (4)||Devices will be notified by the licensing authority CDSCO. Even Addition/deletion will also be notified.||Presently the regulated devices will continue to be regulated. Only classification will be based on the basis of Rule 2. Please refer to First Schedule.||– Based on the classification, class wise list of medical devices shall be published on the website of the CDSCO on condition that, the CLA may from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.|
|3||Chapter III, p#147 Clause 11 & 13||National Accreditation Body & Notified Bodies||Mainly for domestic manufacturing.||– The National Accreditation Body shall not act as a Notified Body. It identifies the conformity assessment activities of Notified Bodies and lay down standards.- The Central Government of India, or the State Governments, may appoint a Government Analyst with appropriate qualification.- The Notified Body approved competent to carry out audit of manufacturing sites of Class A and B medical devices to verify conformance with the Quality Management System.|
– Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices in accordance with sub-rule (2), should register with the Central Licensing Authority.
– Notified Body under sub-rule (3), with an experience of at-least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience.
|4||Chapter V, p#153 Clause 37||License validity: License granted remains valid in perpetuity, unless cancelled or surrendered. Validity issued is for 5 years.||To continue, just keep paying the fee every 5 years.||– It will be for the first time that there will be no requirement of periodic renewal of licences. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered, the registration certificate holder deposits a registration retention fee as specified in the 2nd Schedule every 5 years from the date of its issue.|
|5||Chapter V, p#153 Clause 37||Retention of license fee to be paid every 5 years.||– A licence shall remain valid, unless, it is suspended or cancelled, provided the Indian authorized agent deposits a licence retention fee as specified in the Second Schedule for each manufacturing site and for each device in every 5 years from the date of its issue.|
– If the Registration certificate (RC) holder fails to pay the retention fee on or before due date, the RC holder shall, in addition to the retention fee, be liable to pay a late fee calculated at the rate of 2% of the RC retention fee for every month or part thereof within 90 days, and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.
|6||Chapter V, p#153 Clause 34&37. Second Schedule p# 172||Class C & D Devices. Import License fee to be USD 3000 for the manufacturing site and USD 1500 for each product. For details please refer to Second Schedule.||Same fee for retention as well.||– Authorized agent shall obtain prior approval from the Central Licensing Authority (CLA) in case of any change in the intended use or any major change as specified in the Sixth Schedule of medical devices classified under Class B, Class C or Class D- Grant of licence for additional manufacturing site for the same medical device by the same authorized agent shall be accompanied with a fee and documents as referred in sub-rule (2)- Licence for additional medical device manufactured at the same manufacturing site shall be made by the same authorized agent accompanied with fee as specified in the Second Schedule and respective documents as specified in the Fourth Schedule.|
|7||p# 175 Fourth Schedule||For Import License Regarding Documentation & Information to be submitted, referred in Fourth Schedule.||The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule: Please refer Fourth schedule|
|8||p#201 Sixth Schedule||Post Approval Changes||Prior Approval is required for major changes – Authority to response (Approval/Rejection ) in 60 days. In case no response received in 60 days, it will be deemed to be approved.|| (A) Major changes: 1.material of construction;2.design which shall affect quality in respect of its specifications, indication for use, performance and stability of the medical device;3.the intended use or indication for use;|
4.the method of sterilization;
5.the approved Shelf life;
6.the name or address of,
(i)the domestic manufacturer or its manufacturing site
(ii)overseas manufacturer or its manufacturing site (for import only)
(iii)authorized agent (for import only)
7.label excluding change in font size, font type, color, label design;
8.manufacturing process, equipment or testing which shall affect quality of the device;
9.primary packaging material
(B) Minor changes:
1.design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device;
2.in the manufacturing process, equipment, or testing which shall not affect quality of the device;
3. Packaging specifications excluding primary packaging material.
|9||Chapter p#156 Clause 46||Unique Device Identification of the Medical Devices: effective from 1st Jan, 2022.||-Unique device identification of the medical device. With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.|
|10||Chapter V, p#154 Clause 40||Test License for Testing of Devices, evaluation, clinical investigation will be valid for 3 years||Currently it is for 1 year.||Manufacturing of medical devices for clinical investigation, test, evaluation, examination and demonstration:|
– Small quantity of any class of medical device may be manufactured for the purpose of clinical investigations, test,
evaluation, examination, demonstration or training for which an application shall be made in Form to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule.
– On receipt of an application for test licence in the form and
manner specified in sub-rule (1), the CLA shall, on being satisfied, grant the test licence.
– The licensee shall keep a record of, and shall report to the Central Licensing Authority, the date and quantity of product manufactured under test licence. Duration of licence for clinical investigations, test, analysis, demonstration and training.
|11||Chapter IV, p#148||Loan License Can be obtained under the present Rules||Earlier Loan License in Medical Devices was not permitted.||Application for manufacture for sale or for distribution of Class A or Class B medical device:– Any person who intends to manufacture a Class A or B medical device including in-vitro diagnostic medical device shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority (SLA)- The SLA being satisfied with the requirements will grant a licence to manufacture Class A medical devices or loan licence, as the case may not satisfied, reject the application for reasons to be recorded in writing, within 45 days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of 60 days.|
|12||Chapter VI, p#155 Clause 44||About the Labeling.||Additional Stickering for imported device is permitted. Clause 44(n)||Labeling of medical devices: The following particulars shall be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, namely,|
(a) name of the medical device
(b) the details necessary for the user
(c) the name of manufacturer and address of manufacturing premises
(d) the correct statement about the net quantity
(e) the month and year of manufacture and expiry. and The date of expiry shall be
(f) an indication that the device contains
(g) a distinctive batch number or lot number
(h) storage or handling conditions
(i) Sterile product and sterilization method information
(k) Intended use
(l) to overprint on the label of the device, the words “Physician’s Sample—Not to be sold”,
(m) “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
(n) Way of stickering
(o) in case of small sized medical devices on which information cannot be printed legibly, shall include the
|13||Chapter XII, p#167 Clause 97(i)||The license or the registration certificate, issued under the provisions of Drugs & Cosmetics Act & Rules 1945 prior to the commencement of these rules [GSR 78(E)], shall be deemed to be valid till its expiry or for a period of eighteen months from the date of these rules are notified, whichever is later, under the corresponding provisions of these rules.||Smooth switch over from present license system to the new|
|– the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules,|
1945 prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen months from the date these rules are notified, whichever is later, under the corresponding provisions of the medical device rules
|14||p# 167 First Schedule [See rule 4]||Parameters of Classification|
of Medical Device & In-Vitro Devices
|Please refer First Schedule of the notification|
|15||p# 172 Second Schedule||Fees payable for various license applications||Please refer notification Second Schedule (Fee payable for licence, permission and registration certificate)|
|16||p#221 Eighth Schedule [See Rule 90]||Exemptions||Custom made devices|
E22D24 Medicated D21 dressings D21 to be used in First Aid Kits.
|Class of medical devices:– Custom made device- Medicated dressings and bandages for first aid.- Medical devices supplied by a registered medical practitioner to his own patient or any medical device supplied by a registered medical practitioner at the request of another such practitioner.|
Please refer notification Eighth Schedule
|17||p# 223 Various Forms||Newly introduced Forms applicable for application other activities.|
Only one import license for each Manufacturer.
|Simplified administrative documents.|
Can’t have multiple importers as presently multiple Form 10’s
can be obtained for import, while Registration was held in Form 41 by one single Indian Agent issuing Form 9 for the other distributors to import.
|Please refer Forms section|