If you want to start a medical device trading business in India, you may need to obtain a registration certificate to legally sell, stock, exhibit, offer for sale, or distribute medical devices. Under the Medical Devices Rules, 2017, Form MD-41 is used to apply for registration, while Form MD-42 is the registration certificate granted by the concerned State Licensing Authority.
This registration is important for eligible medical device dealers, distributors, and businesses that want to sell medical devices or in vitro diagnostic (IVD) devices in India.
Whether you are starting a new medical equipment shop, becoming a medical device distributor, or expanding your existing business, understanding the MD-41 application process and MD-42 registration requirements can help you prepare your application correctly.