Under the background of the reform and upgrading of the medical system, the problem of compliance management in the production/management of medical devices has become increasingly prominent. In the process of dynamic inspection, the focus of the supervision of the drug regulatory department on the enterprise will penetrate into all links of the life cycle, strengthen the supervision during and after the event, NMPA establishes a team of full-time inspectors to carry out daily follow-up inspection of the enterprise, and “flight inspection” has become the norm.

Factors driving the rapid growth of medical device technology in China

The rapid growth of Chinese medical device companies has been driven by a number of factors, including strong domestic demand, technology diffusion and government support, as well as a boost from the pandemic.

At present, there are still some problems in China’s medical information system, such as regional closure, non-mutual recognition of data and non-uniform standards. Such “chimney-type” information system is an important factor hindering the development of China’s medical level. With the continuous advancement of policy and technology, the old information islands are being broken by links.

I. Market scale

According to EvaluateMedtech, the market size of Chinese medical equipment has been growing rapidly in recent years, the market size increased from 370 billion yuan in 2016 to 765.5 billion yuan in 2020, with an average annual compound growth rate of 19.9%. It is estimated that the market size of Chinese medical equipment will reach 125.29 billion yuan in 2022.