New Delhi: The Central government recently released the draft notification vide GSR 104(E) dt 09-02-2022, of the Medical Devices (Amendment) Rules, 2022, in consultation with the Drugs Technical Advisory Board.

The amendments made in the Medical Devices Rules, 2017 mandate obtaining an online registration certificate if any person/company intends to sell medical devices exclusively.

Download notification no. GSR 104(E) dt 09-02-2022

To grant registration certificates, the state authorities have been asked to appoint licensing authorities to issue the registration certificates for the medical device seller.

The registration certificate will be required to sell, stock, exhibit, offer for sale or distribute a medical device including in vitro diagnostic medical devices.

The application for online registration has to be accompanied by a fee prescribed in the second schedule, self–certificate of compliance, details of the applicant with ID proof, documentary evidence of ownership/rental occupancy of premises being used, details of competent technical staff monitoring sales activity of the medical devices, a description on other activities being carried within the said premises, and undertaking that the applicant fulfils the storage requirements to handle medical devices.

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https://thehealthmaster.com/2022/02/12/govt-issues-draft-notification-on-amendment-on-sale-of-medical-devices/