New Delhi, the 16th October, 2019 G.S.R.787(E).— Whereas a 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. 87 (E), dated the 4 th February, 2019 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 said Official Gazette were made available to the public on 5 th February, 2019; 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:
Paragraph 1
1. (1) These rules may be called the Medical Devices (Fifth Amendment) Rules, 2019. (2) They shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. In the Medical Devices Rules, 2017, in rule 19, after the proviso, the following proviso shall be inserted, namely: ― “Provided further that the testing laboratories of State Governments and Central Government shall be exempted from the requirement of the accreditation by the National Accreditation Board for Testing and Calibration Laboratories for a period of two years from the date of coming into force of the Medical Devices (Fifth Amendment) Rules, 2019.”.
[F.No.X.11014/1/2019-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note:- The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number G.S.R. 78(E), dated the 31 st January, 2017 and last amended vide notification number G.S.R. 652(E), dated the 13 th September, 2019.