Medical Devices (Amendment) Rules, 2022

The Department of Health and Family Welfare vide notification dated the 18th January, 2022 has issued the Medical Devices (Amendment) Rules, 2022. The amendment provides that a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 if the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance.

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