CDSCO clarification on Registration Certificate for sale of medical devices


The Central Drug Standard Control Organization vide notice dated 21 October, 2022 has clarified that anyone who intends to sell, stock, exhibit, offer for sale or distribute a medical device, including in-vitro diagnostic medical devices must obtain the Registration Certificate.

Application for a Registration Certificate must be made with Form MD-41 to the State Licensing Authority (SLA). The registration certificate shall be issued in Form MD-42.

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