Innovative medical device industry needs clear topics

In order to encourage the research and innovation of medical devices, the relevant state departments have issued the "Special Approval Procedures for Innovative Medical Devices" and the "Regulations on Simplifying the Application for Re-registration of Medical Devices." It can be seen that the innovation of medical devices has become a general trend.

The development of the medical and mechanical industry needs innovation, and national policies also support innovation. The state food and drug regulatory agency stated that in the future, priority will be given to the approval of innovative medical devices and a green channel will be opened.

Medical device industry innovation requires clear definitions and themes

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

However, at present, the polarization of China's ethnic medical device industry is serious, and the gap between domestic medical devices and foreign devices has made domestic enterprises fully aware that only by strengthening innovation can they gain room for survival in the future medical device market, and the status quo will eventually be eliminated by the market.

It is necessary to consider the value of innovative technologies when pricing and charging medical devices. Considering that independent innovation brands must invest a great deal of manpower, material resources, and financial resources in R&D and marketing, they must be scientifically priced, instead of simply following the same as before. The principle of origin (imported and domestic) carries out price classification, pricing and charges.

In the face of vast development prospects and favorable supporting policies, related medical and mechanical enterprises must make full use of their horsepower and accelerate the high-end construction of domestic medical devices.

However, it is worth noting that the definition and theme of “innovation” should be further defined in the medical device regulations, and that domestic innovation, world innovation, and emergency innovation should be distinguished. In terms of the approval process and regulatory model, domestic innovation and the world should also be followed. Different characteristics of innovation and emergency innovation formulate different regulations.