Central Government published draft rules to amend the Medical Devices Rules, 2017, and invited objections and suggestions within thirty days from the date of availability of the Gazette to the public.

The draft proposes omission in rule 3(j), insertion of definition of “Certificate of Registration” in rule 3, insertion of clause (p) in rule 44 regarding labelling requirement for outsourced sterilization, and consequential substitution in rule 44. It also proposes insertion of Ninth Schedule specifying fees for test or evaluation and amendments in rules 19 and 69 to link fees with the Ninth Schedule.

1. (i)These rules may be called the Medical Devices (………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)”.
6. In the said rules, in Chapter III, in rule 19, after sub-rule (2), the following sub-rule shall be inserted namely: –
   “(3) The fees for test or evaluation shall be those specified in ninth Schedule.”
7. In the said rules, in Chapter IX, in rule 69, after the words “in Form MD-33”, the words “accompanied with a fee specified in the Ninth Schedule” shall be inserted.