MANDATORY REGISTRATION CERTIFICATE TO SELL/ STOCK/ EXHIBIT/ OFFER FOR SALE/ DISTRIBUTE MEDICAL DEVICES

November 09, 2022

Kartika 18, 1944

The Directorate of Food Drugs Administration has informed that the Central Govt. vide Gazette notification GSR 754(E) dated September 30, 2022 , has notified that to sell, stock, exhibit or offer for sale or distribute medical device including in vitro diagnostic medical device, a Registration Certificate in form MD 42 is mandatory if the firm is not holding licence under sub Rule (1) of Rule 87 of Medical Devices Rules 2017.

Copy of above Gazette notification is uploaded on the official website of FDA www.dfda.goa.gov.in .

The list of documents required for application of Registration Certificate is also uploaded on the Website. All the concerned distributors/suppliers are requested to obtain this mandatory Registration Certificate within 15 days from this Directorate.

DI/NB/AXP/CR/ 2022/