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.
On July 23, 2020, the General Office of the State Council of China issued the “Key Task of Deepening the Reform of the Medical and Health System in the Second Half Year of 2020”, which clearly required “the implementation of the unique identification of medical devices for key varieties”. Bradynuoen has sorted out and answer the common questions in the implementation process for your reference.
On June 16, 2021, the National Health Commission issued the Notice on Printing and Distributing Opinions on Accelerating the Development of Rehabilitation Medical Work (hereinafter referred to as the “notice”).
On-site inspection points for clinical trials of IVD are formulated according to the Regulations on the Supervision and Administration of Medical Devices, Measures for the Registration and Administration of IVD, Technical Guiding Principles for Clinical Trials (Research) of IVD and other relevant requirements. The specific inspection points are as follows:
On June 10, the Hainan Free Trade Port Law of the people’s Republic of China (hereinafter referred to as the Hainan Free Trade Port Law) was officially promulgated. What benefits will it bring to the import of medical devices?
The Pilot Zone at a Glance
The Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) was established with the approval of the State Council on February 28, 2013. Granted by preferential policies, the Pilot Zone develops the related industries of international medical tourism such as licensed medical treatment, health management, care rehabilitation, medical cosmetology, and anti-aging.
In order to further standardize the registration, application and technical review of the research data on shelf validity of passive implanted medical devices,on June 10, 2021, NMPA issued the Guidelines for Application of Materials for Registration of Shelf Validity of Passive Implantable Medical Devices (Revised in 2021) (Draft for Comments)，which is now open for comment.
On June 9, 2021, the Medical Device Standards Management Center (NMPA) issued a notice to the industry on soliciting opinions on the Guiding Principles for Classification and Definition of Medical Decision-assisted Software (Draft for Soliciting Opinions).
