Of course you need to register. Manufacturers also need to have the system certification of the place where medical devices are produced. Generally speaking, if you add a new product type, the production system certification needs to be re-checked. Medical devices have their own clinics, which are different from medicines. To go to some hospitals with clinical trial qualifications recognized by the state, there should be clinical articles on the website of the State Food and Drug Administration.
First of all, you have to go to a special institution for product testing. After you get the qualified test report, you can carry out system verification and clinical trials in the production area. Then when you have all these materials ready, you can submit them to the Food and Drug Administration for technical review. After the review, you can get the listing registration certificate.