Medical Devices (..Amendment) Rules, 2022 with insertion of Provision and Explanation to ISO 13485 certification requirements.

18th January, 2022
Medical Devices (..Amendment) Rules, 2022 with insertion of Provision and Explanation to ISO 13485 certification requirements.
Regulatory BodyCDSCO Product CategoryMedical Device, IVD for Importer & Manufacturer
The new Medical Devices Amendment includes a series of changes in the Medical Devices Act of 2017. It states that the applicants have to submit an undertaking that he will receive the certificate on or before 31st May, 2022 if the application for Registration has been made on or before 28th February, 2022. If any manufacturer cannot get the ISO Certification before 31st May 2022, the Central Government will cancel the license of medical devices.

Notable Products:IVD, Medical Devices
Applicable For:Importer & Manufacturer
Reference Number:CG-DL-E-19012022-232729
The Medical Devices Rule, 2017 was updated on the 18th of January, 2022, as G.S.R 19(E) with new amendments and provisions related to their ISO certication. The Central Government made the changes by consulting the Drug Technical Advisory Board. The Central Government updated the provisions concerning the ISO certication approval for the medical devices with considering their provisional registration number. If the application for the Registration has been submitted on or before 28th February, 2022, then an undertaking must be provided by the application that the ISO 13485 certicate will be obtained before the 31st of May 2022 concerning clause (iii) of sub-rule (2) of rules 19 B and 19D. In lieu of certicate of compliance, 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 certicate whichever is earlier. The said generated provisional registration number shall be valid for all purposes and in case of such ISO 13485 certicate not obtained before the 31st May, 2022 as per undertaking by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice. As per rule 19C and 19E, Its mandatory for all the registration holders to mention the registration number or provisional registration number for a period up to the 31st May, 2022 on the label of the Medical Device