In recent years, with the national policy and the continuous adjustment and optimization of the industrial structure around the country, the medical device industry, as high technology, high growth, high value-added industry, and both low pollution, low energy consumption, low carbon emissions, fits perfectly with China’s current “carbon peak,” “carbon neutral The development concept of “carbon peak” and “carbon neutral” has been strongly supported by local governments. With the booming development of the medical device industry, the regulatory means in the field of medical devices around the world are becoming more and more complete, the scale of law enforcement is becoming more and more stringent, and the importance of regulatory compliance is increasingly prominent for all kinds of market players in the field of medical devices.
The territory of China engaged in the field of medical devices related to production and business activities must be subject to the supervision of drug supervision and management departments at all levels. The primary basis for the implementation of regulatory actions at all levels of government is the State Council’s “Regulations on Supervision and
