The Medical Devices (Fifth Amendment) Rules, 2019

Oct 18, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on October 16, 2019, after consultation with the Drugs Technical Advisory Board has published the Medical Devices (Fifth Amendment) Rules, 2019 to further amend the Medical Device Rules, 2017.

The amendments made in the Medical Devices Rules, 2017 are:

 In Rule 19 related to “Central medical device testing laboratory”, 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.”

This Notification shall come into effect from October 17, 2019.

[Notification No. G.S.R.787(E)]


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