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:

China Medical Device Design and Entrepreneurship Competition(hereinafter referred to as the “competition”) is about to start，overseas people (including Hong Kong, Macao and Taiwan) are welcome to register for the event.

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?

On June 10, CMDE issued the Notice on Soliciting Comments on the Guidelines for the Examination of Registration of Extracorporeal Membrane Oxygenation (ECMO) Cycle packages (Draft for Comments).

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).

In May 2021, NMPA released 11 new draft guidelines regarding the format of electronic medical device registration management (eRPS) system for both medical device, In Vitro Diagnostics reagents, narcotic drugs, psychotropic drugs, and biological products. Manufacturers and the public can submit opinions and feedback on the new draft guidelines to NMPA by the end of June 2021.