The Ministry of Health and Family Welfare vide notification dated 12th October, 2021 has issued the Medical Devices (Amendment) Rules, 2021. 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 31st May, 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, if any, may be sent by email within 7 days of publication of this amendment.
