Medical Devices

China’s NMPA has issued the requirements for the Temporary Import of Class II and Class III Medical Device for Urgent Clinical Need.

New Greater Bay Area regulations for importing Hong Kong drugs and medical devices starting December 1, 2024 will reduce review time

China’s NMPA has approved Shanghai Wicresoft’s Bioabsorbable Rapamycin Eluting Coronary Stent System through the Innovative Medical Device Green Pathway Programme.

China’s NMPA has announced a suspension of import, sale and use of two medical devices manufactured by SAMO S.p.A. because they failed to comply with regulatory requirements.

MDACS listing is more crucial now for Hong Kong public procurement, especially for MedTech companies looking into entering the GBA market

China’s CMDE has issued a Draft for Comments on its latest update to the Clinical Trial Exemption List. The deadline is August 30, 2024.

China Medical Device Registration for June 2024 were on trend with 2023 overall approvals. Here are some charts to summarize this.

China’s NMPA has issued an update to Radio Frequency Device Requirements in China on July 8, 2024 to ensure the safety.

China’s NMPA introduces Measures for the Supervision and Inspection of Medical Device CROs. They come into effect on October 1, 2024.

China has released an IVD reagent classification catalogue. It was issued by the NMPA and includes all IVDS except those used for blood screening and those labeled with radionuclides.

China’s NMPA is introducing new supervision measures for the medical device entrusted production. This will come into effect on June 1, 2024.

Usability engineering for medical devices registration in China Guidelines were released by the CMDE on March 19, 2024.