The draft rules are issued under the Drugs and Cosmetics Act, 1940 for further amendment to the Medical Devices Rules, 2017. The draft has been published for information of persons likely to be affected, and objections or suggestions may be submitted within thirty days from the date of availability of the Gazette to the public.

The provisions apply to entities governed under the Medical Devices Rules, 2017, including those dealing with standards, quality management systems, testing laboratories, and specified import provisions.

Rule 19H is proposed to be amended to insert additional wording relating to “Quality Management System” after the word “standards” in sub-rule (2), clause (v).

Rule 19J is proposed to be amended to insert additional wording relating to “Quality Management System” after the word “standards” in sub-rule (2), clause (v).

Rule 19 is proposed to be amended by substitution of the marginal heading.

Rule 63 is proposed to be amended to insert additional countries in proviso (iv) of sub-rule (1).

“2. In the Medical Devices Rules, 2017 (hereinafter referred to as said rules), in rule 19H, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted.

3. In the said rules, in rule 19J, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted.

4. In the said rules, in rule 19, for the marginal heading, the following marginal heading shall be substituted, namely: –

“Government Medical Device Testing laboratories”

5. In the said rules, in rule 63, in sub-rule (1), in Proviso (iv), after the words “or Japan”, the words, “or European Union countries,” shall be inserted.”