Applicant shall submit an undertaking for registration of medical device vide Draft Medical Devices (Amendment) Rules, 2021

The Ministry of Health and Family Welfare has notified the Draft Medical Devices (Amendment) Rules, 2021 vide notification dated October 12, 2021. The Draft Rules amend the Medical Devices Rules, 2017 in the following manner:

  • The amendment provides that a person making an application for registration shall on or before the 30th November, 2021, submit an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022.
  • A provisional registration number shall be generated which will remain valid up to the May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Objections and suggestions, received from any person within 7 days will be considered by the Central Government.


*Tanvi Singh, Editorial Assistant has reported this brief.

One comment

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