1. Regulatory risk: The supervision of implantable medical devices involves many departments, such as National Medical Products Administration and Provincial Drug Administration. Different regulatory requirements and standards of different departments will lead to difficulties and obstacles in the registration and filing of enterprises in different provinces or departments.
2. Market risk: The implantable medical device market is fiercely competitive and the market changes rapidly. Enterprises can't adapt to market changes and update their product lines in time, which will lead to unsalable products or elimination.