Notification No.: G.S.R. 744(E) dated August 14, 2026
Applicable Act/Rules: Drugs and Cosmetics Act, 1940 | Medical Devices Rules, 2017
Applicable Section/Rule: Rule 19H, Rule 19J, Rule 19 and Rule 63
Effective Date: August 19, 2026
The Ministry of Health and Family Welfare issued the Medical Devices (Third Amendment) Rules, 2026, further amending the Medical Devices Rules, 2017.
The amendments insert “and Quality Management System” after “standards” in Rule 19H(2)(v) and Rule 19J(2)(v), substitute the marginal heading of Rule 19 with “Government Medical Device Testing laboratories”, and insert “or European Union countries” after “or Japan” in Rule 63(1), Proviso (iv).
(i) These rules may be called the Medical Devices (Third Amendment) Rules, 2026.
(ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette.
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.
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.
In the said rules, in rule 19, for the marginal heading, the following marginal heading shall be substituted, namely: –
“Government Medical Device Testing laboratories”
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.
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