Specifically, it is divided into: 1 class medical devices can be directly produced without a production license, and Class 2 and Class 3 can be produced only with a production license. The premise of obtaining the production license is to have the equipment, site and personnel system corresponding to the product, and to pass the examination of the Food and Drug Administration. How to classify products? You can find it on the website of the Food and Drug Administration.
Product sales: products need a registration certificate, and all 1.2.3 products need to be registered. If it is a trading company, it needs a medical device business license. The application time for product registration depends on the product. Please search by yourself.
The third point is also the most important one you asked: To produce your products by OEM, you need to meet the following conditions: both your company and the enterprises that help you to OEM need to obtain medical device production licenses (there are exceptions, of course, this depends on the products, mainly on the accessories, sometimes on your internal relationship with the Food and Drug Administration, and you need financial skills, so I don't need to explain more).
Next, you may need this: if you produce and sell medical devices in this way of external processing, it may be difficult for you to pass the GMP system certification of medical devices, and you will be regarded as a key regulatory object by the Food and Drug Administration, with greater risks. I suggest you operate with caution.
I hope I can help you with the above hand. Of course, please don't be stingy with your score. Finally, I wish you success in your career.