File No.: MED/48/2024-eoffice
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
FDA Bhawan, New Delhi
Date 29th May, 2024
CIRCULAR
Subject: Testing and evaluation of Medical Devices(MD)/ In vitro diagnostics(IVDs) by Medical Devices Testing Laboratories in the country – Reg. In order to ensure the quality, safety and performance of Medical Devices(MD)/ In vitro diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India has granted registration of Laboratory for carrying out Test or Evaluation of a Medical Device on behalf of a manufacturer, under Chapter X of Medical Device Rules 2017 to strengthen the testing facility in the country It is pertinent to mention that consequent to the implementation of MDR 2017 with effect from 01/01/2018, the Drug Rules 1945 are no longer applicable for MDs/lVDs. Also, the product standards of Medical Devices as prescribed under Rule 7 of the Medical Device Rules (MDR) are mandatory as under.
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