Medical Device Regulations in India under the India Medical Device Rules 2017

Medical device regulations in India are primarily defined by the India medical device rules 2017 (MDR-2017), notified as G.S.R. 78(E). The Drugs and Cosmetics Act, 1940, and the CDSCO (Central Drugs Standard Control Organization) administer the rules. The Drugs Controller General of India is the Central Licensing Authority. For MD-14/MD-15 form submission, dossier related activities, and licence maintenance, see Morulaa's CDSCO medical device registration service. For your Indian license holder, see Indian Authorized Agent (IAA).

How Medical Device Regulations In India Work Under CDSCO Medical Device Rules 2017

Under the India medical device rules 2017, teams familiar with traditional Indian drug law would most likely reflexively turn to the Drugs Rules 1945. The position of the CDSCO’s FAQ is quite different in that the MDR-2017 has primacy under Rule 96 if there is any inconsistency between the two rules and the latter is only supplementary where the former is silent.

From the date of operation of S.O. 648(E), February 11, 2020, all medical devices are covered by the India medical device rules 2017 (MDR-2017) and G.S.R. 102(E) has shifted the industry towards a licensing system, excluding class A non sterile and non measuring devices.

1. Carve out example: Class A (self notifying) devices in India.

2. Class List & Category reasoning:

3. Ref. to CDSCO classification guidelines.

4. Map of System (abridged version)

5. Central Licensing Authority under CDSCO medical device rules 2017 (CDSCO / DCGI)

6. Import of all classes; manufacture of Classes C and D; device classification; clinical investigations and approvals if no predicate exists.

7. State Licensing Authority – manufacture of Classes A and B (refer to alignment of CLA classification);

8. Sale and distribution controls.

9. Overseas manufacturers – import through authorized agents designated through power of attorney (IAA).

10. Regular trade import: Usually MD-14 logic → MD-15 

11. No Predicate / Investigational pathway: Different formats and evidentiary threshold (MD-26 & MD-27).

MDR Rules 2017: Grouping India's Fee And Licence Architecture

The Rule 5 of MDR rules 2017 states that applicants can group the devices on the basis of the “Ministry of Health & Family Welfare Grouping Guidelines”. According to CDSCO FAQs, grouping shall be made as per the guidelines published and not as per the product tree (ERP) of the applicant. Such a grouping could have the following types: single, family, system and group/kit.

Where Indian Grouping Becomes Unforgiving

• Devices which have a different intended use, material used, or other features that fall outside of permissible limits cannot be included in one grouping category (CDSCO July 2025 FAQ). 

• Accessories must be listed on the application if they are in the DMF and IFU (DMF guide).

• If you got permission for a System and afterwards needed some more devices, FAQ addenda suggest the system change to Family and then addition of new models as post approval change.

• Morulaa’s review experience: Group according to intended use, material and shelf life considerations; separate different brands to separate families; don’t merge instruments, accessories and devices for saving fees.

Predicate: Licence Track Vs Investigational Track

 Devices which do not have a predicate in India, a subject to an investigational medical device. They are different pathways which depend on a JTF approval and the presence of a predicate or similar device in the market to the table on the India Registration page helps summarise the Fastrack pathway as well as a pathway which require clinical trial as per the medical device regulations of IndA

Therefore, a “first of its kind in India” device is not just a stricter MD-15. It may even move you to the category of Rule 63 approval system (MD-26/MD-27). Procedure for filing of this route: MD-26 and MD-27 forms of CDSCO.

Medical Device Regulations in India: India Only Landmines Beside Grouping And Predicate

• Conflicts in classification may be resolved. Under CDSCO medical device rules 2017, if IMDRF/GHTF classification and Indian classification are different, CDSCO FAQ procedure permits India to take the higher classification (classification guide).

• Centralised Classification Enforcement. State Licensing Authorities (SLAs) can license neither unclassified nor unlisted devices before receiving their classification from Central Licensing Authority (CLA) (October 2025 Directive).

• Perpetual licence must be renewed every five years. Trial licences are valid for a certain period only.

• India specific labelling (including labelling at warehouse pursuant to rule 44(n) in FAQ procedure and sterilization license number in packaging of sterile products): labelling requirement.

• Import ports are controlled by the ADC who verifies all documents are clearance

Which Morulaa Page To Use

Sources

• Medical Devices Rules, 2017 (G.S.R. 78(E)) Rule 5, investigational device definition, Rule 63, Rule 96

• Draft Medical Devices (Amendment) Rules, 2026 (G.S.R. 515(E), 23 June 2026)

• CDSCO October 23, 2025 Circular on Mandatory Central Classification First

• CDSCO 2026 Sterilization Loan License Exemption and Labelling Directive

• S.O. 648(E); G.S.R. 102(E) (as applied in CDSCO FAQ practice)

• CDSCO FAQ MD_01-2024; Addendum 09.07.2025; Addendum-03 03.11.2025

• MoHFW/CDSCO Grouping Guidelines

• Morulaa India Detailed Regulatory Pathway CDSCO (2025–2026)

• FAQs create awareness; filings follow the Act, Rules, current circulars, and portal requirements.