What is the process of setting up a medical device manufacturer?

Development of enterprise (registered products) standards - production license processing - for business registration - product testing -Product clinical trials (the vast majority) - Quality System Assessment - Declaration of registration, the regulations used are, medical device standards management, classification rules, registration methods, production license management, Clinical trial regulations, specification management regulations, etc. Specifically see the State Food and Drug Administration website www.sfda.gov.cn和各地 (Food) Drug Administration website (such as www.bjda.gov.cn). If you need professional advice (fees) can contact me. The plant (site) is run first. There are certain specialized requirements, especially for implantable and sterile products. Establishing a medical device manufacturing company is very complicated. It requires a lot of unexpected costs. Just one product registration clinical registration alone (excluding plant and personnel) costs 20-50 million. So have to weigh their own.