Only need business license, production license (except for a class of products) and product registration certificate, in the process of declaring the product registration, the Drug Administration will be the quality management system assessment of the enterprise or the audit of the implementation rules of production, will issue a report on the assessment, the other certifications (such as CE, FDA, ISO13485) are voluntary. However, medical devices generally do ce certification. If you export to the U.S., you must be fda. If you get the CFDA account. Then, you need to contact the hospital related purchases directly through distributors or yourself to open something like an account. Then it is the salesperson to soak the doctor and beg the other party to use their own company's products in this examination/surgery/treatment process...