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Govt relaxes dossier filing norm for Medical Devices

June 21, 2022

Download Notification No. GSR 450(E) dated 15-06-2022, link is given below: The ministry of health and family welfare has issued a draft notification vide Notification No. GSR 450(E) dated 15-06-2022, relaxing the requirement for submitting Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) certificates during the Device Master Filing for medical devices other than in vitro diagnostic devices, under Medical Devices Rules 2017.