Medical Devices

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.

GB9706.1-2020 deadlines updated and released by NMPA for compliance, medical device manufacturers must comply with GB9706.1-202 standards.

China’s NMPA has released its medical device sampling inspection plan for 2024. Find out if your medical device is due for inspection this year by reading our article.

China’s NMPA has recently released an update to the recommended clinical evaluation pathways for medical devices that are listed in the China Medical Device Classification Catalogue.

Hong Kong MDACS listing now accepts medical devices approved by Singapore HSA, with online submissions available starting April 15, 2024