Recently, the CMDE of the NMPA has issued the Guidelines for the Examination of Medical Device Software Registration (revised in 2022). The new version has revised its content and requirements regarding the concept, survival cycle, validation, testing, validation and functional use of the medical device software. more…
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.
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.
On June 1st, 2021, the newly revised Regulation on the Supervision and Administration of Medical Devices (Order 739 issued by the State Council) entered into force in China. Order 739 is the fundamental of all medical device/IVD regulations & guidelines in China. Manufacturers shall comply with Order 739 for all regulatory, clinical, manufacturing, and commercialization activities in China. more…
