Medical Device Rules, 2017: Regulatory Updates India

CDSCO Medical Device Rules, 2017 India

Apply for MD- 15 License on SUGAM

India Medical Device Regulations

The Indian Health Ministry‘s updated draft of medical device regulation in 2017 called “The Medical Device Rules 2017 (MDR 2017, India)” 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 (MDR, 2017) 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.

Risk based classification system in MDR 2017
Application to be made in MD-14 and Import License Obtained in MD-15
Regulations are by CDSCO in India
License is valid for 5 Years and then has to be applied under 'Retention' category
Approvals from GHTF Countries can be leveraged (USA, UK, Europe, Japan, Australia, Canada)
Availability of Substantially Equivalent (Predicate) impacts medical device approval timelines in India
Changes make to the medical devices must be updated via post approval on yhr SUGAM portal online

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. Classification and Regulatory Authorities of India

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. The deadline provided by the CDSCO has passed now, and notified medical devices which were previously marketed in India also need to comply and cannot be sold without a license. Class A non-sterile, non-measuring medical devices manufacturers have to self declare on the SUGAM portal.

If you are manufacturing locally in India a Class A or Class B device, the State Licenscing Authorities (SLAs) are responsible to issue the certificates. However if you are an overseas manufacturer of any Risk Class Device or a local Indian Manufacturer of Class C or Class D device, then the Central Licensing Authority shall be the competent authority for enforcement of the Medical Device Rules, 2017 India.

2. Licensing and Import Requirements

An authorized agent with a valid wholesale drug license can apply on the SUGAM portal to the CDSCO via MD-14 application for to import medical device for obtaining a registration licence or Import License in form MD-15. Further details about a Authorized Agents of CDSCO can be read found in – Indian Authorized Agent for Medical Device Companies.

Have approval from USA, Europe, UK, Canada, Australia or Japan (GHTF Countries) ? There is similar product to yours (Predicate) approved in India?

A licence can be fast tracked 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 GHTF countries (Australia, Canada, Japan, European Union Countries, or United States of America) and a substantial equivalent predicate in the India market.

Don't have GHTF Approval and/ or Predicate - But Your a Class A or Class B?

You can get approval in india without local clinical trials provided you have a FSC from the country of origin and suffecient clinical data, safety and performance data

Don't have GHTF Approval and/ or Predicate - But Your a Class C or Class D?

Clinical Investigation in India is mandatory and the Phase of trials depends on availability of randomised control data and decision of the Special Expert Committee (SEC)

How Long is the license Valid?

A licence shall remain valid for five years from the date of its issue. 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. In case of any change in the intended use or any major change, authorized agent shall obtain prior approval from the Licensing Authority to ensure continuity of the license under Retention category

3. Labelling Requirements

Typically labels which are compliant with EU-MDR or US-FDA are compliant with Indian requirements. In Addition to the standard details Importer Details which contains information of the Authorized Indian Agent. Details which must be included on the labels are:

i) Sterile devices: the sterilization date may be given as the date of the manufacture of the device. if the device is supplied as a sterile product, its sterile state and the sterilization method should be indicated

ii) Expiry date: Raw materials details such as stainless steel/titanium and supplied non-sterile, the expiry date may not be necessary

iii) Unique device identification of the medical device shall contain device identifier and production identifier. (a) Device Identifier is the global trade identifier number; (b) Production Identifier is details about serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date

iv) Clinical Investigation: if the device is intended for clinical investigation: to overprint on the label with the words “FOR CLINICAL INVESTIGATION ONLY

v) Legibility & Sold to Hospitals Mark: 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. 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)

4. Other Important Forms

i) Form MD-27 – Apply for Products without Predicate: 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. The permission holder of Form MD25 shall submit the Periodic Safety Update Report to the Central Licensing Authority every 6month for the first 2 years, followed annually 2 years submission. The permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within 15 days of the awareness of the event to the Central Licensing Authority.

ii) Form MD-23 – Clinical Investigation: Permission to conduct clinical investigation of a new medical device in India either via pilot or pivotal study. Approval from the ethics committee and a detailed study plan with all necessary certification is mandatory for a manufacturer or importer to perform clinical investigation in India.

5. Documents Required

i) Certification documents (ISO 13485, Free Sale Certificate, Declaration of Conformity, etc.)

ii) Manufacturing Site documents (Plant Master File)

iii) Device Technical dossier

6. CDSCO fees

Device Class	Manufacturing Site Fees (Per Legal Site)	Device Family Fees (Per Device Family)
Class A Self-Notified	US $0.00	US $0.00
Class A Notified	US $1000.00	US $50.00
Class B	US $2000.00	US $1000.00
Class C	US $3000.00	US $1500.00
Class D	US $3000.00	US $1500.00

The Below Table Gives the Set of Key Features of Medical Device Rules 2017:

Sl.No	Referred Section of the Notification	Salient features as Observed in the section	Remarks if any	Medical Device Rules 2017
1	Chapter II, p#146 Rule 4 (1 & 2). Click to learn more	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 Rule 4 (4). Click to learn more	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 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 Rule 11 & 13. Click to learn more	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 Rule 37. Click to learn more	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 Rule 37. Click to learn more	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 Rule 34 & Rule 37. Second Schedule p# 172. Click to learn more	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. Click to learn more	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. Click to learn more	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 Rule 46. Click to learn more	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 Rule 40. Click to learn more	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. Click to learn more	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 Rule 44. Click to learn more	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 preceded by the words “Expiry date” or “Shelf Life” (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 (j) Precautions (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 information necessary for product identification and safety such as information covered by clauses (a), (b), (c), (d), (e), (g), and (k), and (m) shall be included.
13	Chapter XII, p#167 Rule 97(i). Click to learn more	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 rules.	– 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]. Click to learn more	Parameters of Classification of Medical Device & In-Vitro Devices		Please refer First Schedule of the notification.
15	p# 172 Second Schedule. Click to learn more	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]. Click to learn more	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. Click to learn more	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.