22 July 2019


Notifications & Circulars

Ministry of Health and Family Welfare

01.08.2018

Law of Evidence

Medical Devices (Amendment) Rules, 2018

MANU/HFAM/0099/2018

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.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Medical Devices Rules, 2017, in the Fourth Schedule, in Part II, in paragraph (ii), for clause (h), the following clause shall be substituted, namely:-

"(h) In case of in-vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant:

Provided that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority".

Tags : Medical Devices Amendment Rules

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