Producers: look at the type of product to determine whether you need to obtain a medical device production license
Specifically divided into: Class 1 medical devices can be produced directly without a production license, Class 2 Class 3 need to have a production license to produce. The prerequisite for obtaining a production license is to have the equipment and personnel system corresponding to the product and through the Drug Administration review. How to categorize the product you can go on the Drug Administration website to check
Product sales: the product needs to have a registration certificate, all 1.2.3 types of products need to be registered. If it is a trade type of company then you need to have a medical device license, product registration application time depends on the product, specific search for yourself
The third point is also the most important you asked: OEM way to produce your products, the conditions required are: your company and help you OEM companies need to obtain a medical device manufacturing license, (of course there are exceptions to this need to) (Of course, there are exceptions, this needs to depend on the product, mainly in terms of accessories, and sometimes also depends on the relationship between you and the Drug Administration within the relationship, but also you involved in the financial aspects of the skills, not much explanation)
The next point that may be used by you: if you're this kind of outside the processing of the way the production and sale of medical devices, it may be difficult to pass the medical device GMP system certification, and will be considered by the Drug Administration as a key target of supervision and management, the risk of a relatively large number of people. Large, it is recommended that you operate with caution
The above purely hand-typed, I hope to help you, of course, please do not begrudge you points, and finally, I wish you success in business