The Ministry of Health and Family Welfare Vide Notification dated 16th October 2019 has published the Medical Devices (Fifth Amendment) Rules, 2019 to further amend the Medical Device Rules, 2017. This Notification shall be effect from October 17, 2019.
Highlights of the Amendment:
Under Rule 19 of Medical Device Rules, 2017 related to establishment of Central medical devices testing laboratory, the following proviso has been inserted through this amendment:
“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.”
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