Whether it is the development situation of the domestic medical device industry or the development status of the global medical device industry, it shows that the current medical device companies can only gain survival space in the future medical device market by strengthening innovation, and the status quo will gradually be eliminated by the market.

 

In order to encourage research and innovation in medical devices, in March this year, the State Food and Drug Administration issued the “Special Approval Process for Innovative Medical Devices” and the “Regulations on Simplifying the Re-registration of Medical Devices”, and stated that it will be innovative medical devices in the future. Implement priority approval and open a green channel.

 

According to relevant policies, innovative medical devices will be given priority. However, the declared product must have the independent intellectual property rights of the core technology of the product. The main mechanism of the product is the first in China. The product performance or safety is fundamentally improved compared with similar products. The technology is at the international leading level and has significant Clinical application value, etc.

 

Some experts said that in the medical device regulations, the definition and theme of "innovation" should be further clarified, and domestic innovation, world innovation and emergency innovation should be distinguished. In the approval process and supervision mode, we must also follow domestic innovation, world innovation and Different characteristics of emergency innovation are formulated with different regulations.

 

For innovative medical devices, the food and drug supervision and management departments at all levels and related technical institutions will, in accordance with the principles of early intervention, special person responsibility, and scientific examination and approval, conduct examination and approval without premature reduction of standards and procedures. All kinds of requirements indicate the promotion of China. Confidence in the development of medical device innovation.