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G.S.R. 318(E) — Medical Devices (Third Amendment) Rules, 2019

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New Delhi, the 18th April, 2019 G.S.R. 318 (E).— The following draft of certain rules further to amend the Medical Device Rules,

2017, was published 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) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 1187 (E), dated the th December, 2018, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas copies of the Official Gazette were made available to the public on 8 th December, 2018; And whereas objections and suggestions received from the public on the said 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 the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:―

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1. (1) These rules may be called the Medical Devices (Third Amendment) Rules, 2019. (2) They shall come into force on the date of their publication in the Official Gazette.

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2. In the Medical Devices Rules, 2017(hereinafter referred to as the said rules), in rule 91, after the words “may apply to the Central Licensing Authority”, the words “for Class C and Class D medical devices and State Licensing Authority for Class A and Class B medical devices” shall be inserted.

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3. In the said rules, in the Second Schedule, in the Table relating to “Fee payable for licence, permission and registration certificate”, against serial number 51, in column (3) for the word “distinct”, the words “category of” shall be substituted.

[F.No. X.11014/29/2018-DR] Dr. MANDEEP K BHANDARI, Jt. Secy. Note:― The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 78 (E), dated 31 st January, 2017 and last amended vide notification number G.S.R 224(E), dated the th March, 2019.