Regulatory risk and market risk.
1. Regulatory risk: The supervision of implantable medical devices involves multiple departments, such as the State Drug Administration, provincial drug regulatory bureaus, etc. There are differences in the regulatory requirements and standards of different departments, which will This leads to difficulties and obstacles in the registration and filing of enterprises in different provinces or different departments.
2. Market risk: Competition in the implantable medical device market is fierce and the market changes rapidly. If companies cannot adapt to market changes and update product lines in a timely manner, products will be unsaleable or eliminated.