Health Ministry Proposes Perpetual Validity for Medical Device Licences
New Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare (Department of Health and Family Welfare) has issued a draft notification proposing amendments to the Medical Devices Rules, 2017, introducing a series of regulatory changes relating to registration, licensing, documentation, testing, and validity provisions for medical devices, including in vitro diagnostic medical devices.
The draft notification, published in the Gazette of India (G.S.R. 883(E)) on December 4, 2025, has been issued under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB). The Central Government has invited objections and suggestions from all persons likely to be affected by the proposed amendments.
According to the notification, the draft rules will be taken into consideration after the expiry of 30 days from the date on which copies of the Gazette are made available to the public. Objections or suggestions, if any, may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Room No. 437, C-Wing, Nirman Bhavan, New Delhi – 110011, or emailed to drugsdiv-mohfw@gov.in
The proposed amendments, titled the Medical Devices (Amendment) Rules, 2024, seek to introduce changes across multiple provisions of the Medical Devices Rules, 2017. Among the key proposals are amendments to Rules 44 and 45, allowing the use of registration numbers for Class A (Non-Sterile and Non-Measuring) medical devices in specified cases.
The draft also proposes the omission of the words “AND NOTIFIED BODY” from the heading of Chapter IX and introduces a new compliance requirement under Rule 85, mandating that holders of registration certificates furnish reports of test or evaluation results of medical devices in Form MD-44. Corresponding changes have been proposed in Form MD-11 to align inspection and documentation requirements.
The Gazette notification finally declared:
1. (i) These rules may be called the Medical Devices (......Amendment) Rules, 2024.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.
2. In the Medical Devices Rules, 2017 (hereinafter referred to as said rules), In the said rules, in rule 44, clause (m), after the word or “M. L”; the word “or “Registration number” or “Reg. No.” in case of Class A (Non-Sterile and Non-Measuring) Medical Devices” shall be inserted.
3. In the said rules, in rule 44, clause (n), after the word “import licence number”, the word “or “Registration number” or “Reg. No.” in case of Class A (Non-Sterile and Non-Measuring) Medical Devices” shall be inserted.
4. In the said rules, in rule 45, clause (e) after the word “Lic. No.”; the word “or “Registration number” or “Reg. No.” in case of Class A (Non-Sterile and Non-Measuring) Medical Devices” shall be inserted.
5. In the said rules, in rule 45, in first proviso, after the word “manufacturing licence number” the word “or Registration number in case of Class A (Non-Sterile and Non-Measuring) Medical Devices” shall be inserted.
6. In the said rules, in Chapter IX, in heading, the word “AND NOTIFIED BODY” shall be omitted.
7. In the said rules, in rule 85, after sub-rule (x), the following rule shall be inserted, namely:
“(xi) The person holding registration certificate shall furnish reports of the results of tests or evaluation of a medical device in Form MD-44.”,
8. In the said rules, in rule 85, in sub rule (ix), after the words “inspection book”, the words “in Form MD-11” shall be inserted.
9. In the said rules, in Second Schedule, at Sr no. 39(h), the following shall be substituted, namely:
“(h) One overseas site manufacturing Class C or Class D in vitro diagnostic medical device”
10. In the said rules, in Fifth Schedule, under the clause 2 Applicability may be substituted as under:
“The provisions of this Schedule shall be applicable to manufacturers of Medical devices including In-vitro diagnostic medical devices.”
11. In the said rules, in Fifth Schedule, in the Annexure „A‟ after the word “In vitro diagnostic medical devices (Kit/Reagents)”, the following shall be inserted:
Name of Device | Type of Operation | ISO Class (At rest) |
Other medical devices | All the manufacturing activity | The manufacturer shall environmental adopt as per appropriate applicable requirements standards and norms. |
12. In the said rules, in Appendix, in “Form MD-2 and Form MD-40,
i. after the point no. 3, the following shall be inserted.
“4. The registration certificate shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the registration certificate holder deposits a registration retention fee as per the provisions of Medical Devices Rules, 2017.”
13. In the said rules, in Appendix, in “Form MD-5,
i. after the point no. 3, the following shall be inserted.
“4. The licence shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.
14. In the said rules, in Appendix, in “Form MD-6
i. after the point no. 3, the following shall be inserted.
“4. The licence shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.
15. In the said rules, in Appendix, in “Form MD-9,
i. after the point no. 4, the following shall be inserted.
“5. The licence shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the
licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.
16. In the said rules, in Appendix, in “Form MD-10,
ii. after the point no. 4, the following shall be inserted.
“5. The licence shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.
17. In the said rules, in Appendix, in “Form MD-11”,
i.After the word “See clause (vii) of rule 26” the word “and sub-rule (ix) of rule 85” shall be inserted.
ii. At (A) (1), after the word “licensee”, the word “ or Registration holder” shall be inserted.
iii. At (A) (2), after the word “licence Number”, the word “or Registration number” shall be inserted iv. At
(B) (i), after the word “serially numbered”, the word “and duly stamped by the Central Licensing Authority/State Licensing Authority” shall be omitted.
v. At (B) (ii), after the word “licence Number”, the word “or Registration number” shall be inserted vi. Below the word “*State Licensing Authority”, the word “[To be signed digitally]” shall be omitted and the word “Signature, Seal or Stamp” shall be inserted.
vii. At Notes (i), (ii), (iii), after the word “licensee”, the word “or Registration holder” shall be inserted.
18. In the said rules, in Appendix, in “Form MD-15,
i. after the point no. 5, the following shall be inserted.
“6. The licence shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.
19. In the said rules, in Appendix, in “Form MD-34”,
ii. In the heading after the words “sub-section (1) of section”, the number “22” shall be inserted. iii. Below the marginal heading, the word “To……….” shall be inserted
20. In the said rules, in Appendix, in “Form MD-35”,
i. Below the marginal heading, the word “To………” shall be inserted.
21. In the said rules, in Appendix, in “Form MD-36”,
i. Below the word “Details of sample of medical devices”, the following table shall be inserted
S. No. | Name of the Device | Batch No./Lot No. of the device | Name and address of the premises | Brand name (if any) | Date of manufacture | Date of expiry/use before | Quantity |
22. In the said rules, in Appendix, in “Form MD-37”,
i. Below the word “Details of samples”, the following table shall be inserted
S. No. | Name of the Device | Batch No./Lot No. of the device | Name and address of the premises | Brand name (if any) | Date of manufacture | Date of expiry/use before | Quantity |
23. In the said rules, in Appendix, in “Form MD-38”,
i. After the word “Details of sample of medical device”, the word “with name of medical device which is
purports to contain” shall be omitted.
ii. Below the word “Details of sample of medical device”, the following table shall be inserted.
iii.
S. No. | Name of the Device | Batch No./Lot No. of the device | Name and address of the premises | Brand name (if any) | Date of manufacture | Date of expiry/use before | Quantity |
24. In said rules, in Appendix, after the “Form MD-43”, the following form shall be inserted, namely:
Form MD-44
[See sub-rule (xi) of rule 85]
Report of Test or Evaluation by registered Medical Device Testing Laboratory
1. Name of individual or organization from whom sample received.
2. Reference number and date of the senders request.
3. Number of samples:
4. Date of receipt of the sample.
5. Details of Medical Device / Raw material / Components as obtained from the manufacturer:
a. Name of Medical Device / Raw material / Components:
b. Manufacturer's name:
c. License no (if any)
d. Batch number/Lot No.
e. Date of manufacture (if any)
f.Date of expiry (if any)
