Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-13122025-268478
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
NEW DELHI, THURSDAY, DECEMBER 4, 2025/AGRAHAYANA 13, 1947
8160 GI/2025
(1)
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi the 4th December, 2025
G.S.R. 883(E). -The following draft of certain rules to amend Medical Device Rules, 2017, which the
Central Government proposes to make, in exercise of the powers conferred by Sub-section (1) of section 12 and Sub-
section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation
with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby and notice is
hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days
from the date on which copies of the Gazette of India containing these draft rules are made available to public;
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Under
Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 437, C Wing, Nirman
Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
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 | The manufacturer shall environmental requirements standards and norms. adopt as per appropriate
| activity | applicable
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. | Name of | Batch | Name and | Brand | Date of | Date of | Quantity
No.| the | No./Lot No.| address of the | name | (if manufacture) | expiry/use |
| Device | of the device | premises | (if any) | | before |
---|----------|-----------|------------------|--------|----------------|------------|---------
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. | Name of | Batch | Name and | Brand | Date of | Date of | Quantity
No.| the | No./Lot No.| address of the | name | (if manufacture) | expiry/use |
| Device | of the device | premises | (if any) | | before |
---|----------|-----------|------------------|--------|----------------|------------|---------
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. | Name of | Batch | Name and | Brand | Date of | Date of | Quantity
No.| the | No./Lot No.| address of the | name | (if manufacture) | expiry/use |
| Device | of the device | premises | (if any) | | before |
---|----------|-----------|------------------|--------|----------------|------------|---------
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:
с. License no (if any)
d. Batch number/Lot No.
e. Date of manufacture (if any)
f. Date of expiry (if any)
6. Results of test or evaluation with test protocols (detailed report if any may be enclosed with this Form):
a. *Physical/ Physiochemical/Electronics/Electrical/Mechanical test :
b. *Chemical test:
c. *Biological/Microbiological/Biomedical test:
d. *Sensitivity & specificity (in case of in vitro diagnostics):
e. *Other Test specific to the Medical Device:
Based upon the test or evaluation and in the opinion of the undersigned, the sample referred to above is of standard
quality/ not of standard quality, as defined in the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017,
for the reasons given below:
Date.....................
Signature of Person-in-charge of testing
*Delete whichever is not applicable
[F. No. X.11035/112/2024-DRS]
HARSH MANGLA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification number G.S.R. 78(E),
dated 31st January,2017 and last amended vide notification number GSR ........ (E) dated...............
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and Published by the Controller of Publications, Delhi-110054.