Deepening the Reform of Medical Device Approval, and setting up an Efficient and Smooth Consultation and Communication Platform by Information Means

  • 2018-07-04

Medical equipment is an important foundation for the construction of a health protection system and an important indicator of a country’s scientific and technological progress and national health protection capacity. In the past two years, China has also attached great importance to the rapid and healthy development of the medical device industry, and has issued a number of policies to encourage and support the innovation and development of the medical device industry.

At the on-site investigation meeting of China Food and Drug Administration's medical device approval review held on the 2nd, Sun Lei, Director of the Medical Device Technology Evaluation Center of China Food and Drug Administration, said: “Under the principle of delegating power, strengthening regulation and improving service, we optimized the review process, so that data are more available. Thus it is more convenient for applicants. We allocated resources reasonably according to the product risk level and management category, assigned specific person to manage innovative products and perform early intervention, and under the premise of no reduction in standards and procedures, we gave priority to innovative medical devices and projects with approval priority in the process of technical approval. ”

In addition, according to the reform requirements of the review system, the center simultaneously carried out optimization and rebuilt review information system to meet the needs of review work, study and formulate the content, format and coding requirements of filing materials for China’s electronic Regulated Product Submission (eRPS) in combination with actual working condition and electronic filing requirements for international relevant registration in the Regulated Product Submission (RPS) agreed on International Medical Device Regulators Forum (IMDRF), established a unified online reporting platform for acceptance review and approval of medical devices, and realized electronic submission, review and approval of medical device registration applications.

“Next year, we will launch the electronic submission system, and manage medical devices with higher management concepts. Maybe at that time, some companies may not dare to apply. At the same time, there will be more medical device mergers and acquisitions, and SMEs will be merged in a continuous manner. “Sun Lei said.

At present, there are 15,343 medical device manufacturers in the country, but half of the enterprises have an output value of less than 20 million. The medical device reform will further aggravate the merger and reorganization of the medical device industry. Industry experts predict that in the next 5 to 10 years, the "aircraft carrier" of China’s medical device industry will likely be born in the Pearl River Delta, the Yangtze River Delta, or the Circum-Bohai Sea Region.