Recently, the Yangtze River Delta Sub-center for Medical Device Evaluation (“Yangtze River Delta Sub-center”) of the National Medical Products Administration (NMPA) officially launched the review of medical devices. As of June 18, the Yangtze River Delta Sub-center has completed 38 filing review projects and eight review projects.
With the recent Global Conference on Health Industry Cooperation and the China-CEEC Summit on Innovation and Development in Medicine and Health, cooperation between China and CEECs in the fields of bio-pharmaceuticals, medical devices, vaccine research and development, and health services has been further strengthened.
According to the statistics of authoritative departments, the idle rate of equipment in hospitals is as high as more than 20%, and the utilization rate of some medical equipment is too low, resulting in a large number of medical resources being wasted. The reasons come from three aspects, one is the manufacturer of medical equipment, the second is the hospital, the third is the government.
According to the import and export data of key commodities from the General Administration of Customs of China, from January to April 2021, China’s import and export volume of IVD-related products (mainly IVD reagents and IVD instruments) reached 12.488 billion US dollars.Of this, imports amounted to US $6.285 billion and exports to US $6.204 billion.
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The Changes in management methods of class I medical devices
As is known to all, China implements classified management of medical devices according to the level of risk. The 2000 edition of the Regulations carried out unified registration management for all categories of medical devices, and the 2014 revised Regulations has changed class I medical devices to filing management.The original intention of this reform is to implements the concept of risk management and improves the efficiency of supervision.
In recent days, the Guangdong Provincial Drug Administration has issued the “Interim Regulations (Draft) on the Management of Urgently Needed Clinical Imported Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area of Guangdong Province (Draft)” to solicit public opinions. Even if it is clinically urgently needed, there are only three special circumstances that can choose to import.
On June 20, Hainan Free Trade Port issued the White Paper on the Construction of Hainan Free Trade Port (2021) for the first time, showing the achievements of the construction of Hainan Free Trade Port in an all-round way, and comprehensively describing the main policies and major measures in promoting the construction of Hainan Free Trade Port in the past year.
The name of medical device products involves registration/filing, production, circulation, use and other links. In order to connect and coordinate with relevant regulations, the Medical Device Standards Management Center of the State Drug Administration refer to the sub-category of the Medical Device Classification Catalogue released in 2017,and set up a professional domain structure of common name naming guidelines .
On June 21, GPS III® Platelet Concentration System produced by global orthopedic professional brand Zimmer Biomet completed the first treatment in the General Hospital of Hainan Lecheng Medical Tourism Pilot Zone of mainland China. The operation was performed by Professor Lin Jianping, director of the orthopedic medical center.
A few days ago, CFDA issued the Classification and Definition Principles for Recombinant Collagen Medical Products(hereinafter referred to as the Classification and Definition Principles) to further clarify the management attributes and management categories of recombinant collagen medical products, and provided the guidance documents for the classification and definition and the compliance of innovative product research and development.
