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4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 14th August, 2026
G.S.R. 743(E).— Whereas a draft of certain rules further to amend Medical Device Rules, 2017,
were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R.
270(E), dated the 10th April, 2026 as required by Sub-section (1) of section 12 and Sub-section (1) of section
33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), inviting objections and suggestions from all person
likely to be affected thereby before the expiry of a period of thirty days from the date which on the copies of
the Official Gazette containing the said notification was published were made available to public;
And whereas, copies of the said Official Gazette were made available to the public on 10 th April,
2026;
And whereas, objections and suggestions received from the public on the said draft rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical
Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017,
namely: ⸻
1. (i) These rules may be called the Medical Devices (Second Amendment) Rules, 2026.
(ii) These rules unless specified otherwise, come into force on the date of their final publication in
the Official Gazette.
2. In the said rules, in clause (j) of rule 3, the word “of a licencee” shall be omitted.
3. In the said rules, after the clause (y)of rule 3, the following clause shall be inserted:
(ya) “Certificate of Registration” means a registration certificate granted by the State Licensing
Authority or the Central Licensing Authority in Form MD-2, Form MD-40 and Form MD-42 as the
case may be.”
4. In the said rules, after clause (o) of Rule 44, the following clause shall be inserted.
(p) In case of medical device manufacturer who outsourced the sterilization activity at the site of
another facility having valid license to carry out sterilization process of medical devices, the license
number of the sterilization site should be mentioned on label of the device. The sterilization site
license number by preceding the words “Sterilization sites Manufacturing License Number” or “Ster.
Mfg. Lic. No.” or “S.M. L.”
5. In the said rules, in the clause (o) of Rule 44, after the words “and (m)”, shall be substituted by the
words, “(m) and (p).”
Provided, the compliance with clause (p) shall be mandatory with effect from six months from the date
of this notification.
6. In the Medical Devices Rules, 2017, (hereinafter referred to as the said rules), after Eighth
Schedule, the Ninth Schedule shall be inserted namely: -
