MANU/HFAM/0099/2018

Ministry : Ministry of Health and Family Welfare

Department/Board : Health and Family Welfare

Notification No. : GSR729(E)

Date of Notification : 01.08.2018

Date of Publication : 01.08.2018

Notification/ Circulars Referred : Number G.S.R 412(E) dated 27.04.2018 MANU/HFAM/0053/2018;Notification number G.S.R 78(E), dated the 31st January, 2017 MANU/HFAM/0017/2017

Industry: Health Care

Citing Reference:
Number G.S.R 412(E) dated 27.04.2018 MANU/HFAM/0053/2018  Referred

Notification number G.S.R 78(E), dated the 31st January, 2017 MANU/HFAM/0017/2017  Modified

Medical Devices (Amendment) Rules, 2018

G.S.R.729(E).--Whereas a draft of certain rules to amend the Medical Device Rules, 2017 was published as required under sections 12 and 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 412(E) dated 27.04.2018 in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) by the Central Government, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Official Gazette containing the said notification were made available to the public;

And whereas, copies of the Official Gazette containing the said notification were made available to the public on the 27th April, 2018;

And whereas, all objections and suggestions received in response to the said draft notification have been duly 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, namely:-

1.       (1) These rules may be called the Medical Devices (Amendment) Rules, 2018.