Medical Devices

Real-world evidence research design and statistical analyses guideline has been released by China’s Center for Medical Device Evaluation.

China’s NMPA has released revised guidelines on preparing IVD IFU (Instructions for Use) by CMDE on January 3, 2024.

China’s NMPA has released an update of the Medical Device Standards Catalogue on January 15, 2024. It includes 1974 medical device standards.

China’s NMPA has issued revised medical device business standards which will come into effect on July 1, 2024.

NMPA conducted China medical device supervision inspections on 11 different categories and announced the sampling results.

CMDE has been exploring the use of Real-World Evidence to support clinical evaluation since 2018 and is of increasing importance.

China’s NMPA has released draft guidelines for writing medical device IFU and seek for Industry stakeholders' comment until December 1, 2023.

Breakfast seminar on health technology in Hong Kong and GBA will be carried out on November 27, 2023, at the Finland Chamber of Commerce.

Medical devices urgently needed for clinical use in China have new draft requirements announced by the CMDE for temporary importation.

China medical device sampling inspection results have recently been announced by the NMPA on September 28, 2023

China medical device master filing aims to protect confidential information from being disclosed during the NMPA registration process

China launches an Expert Consultation Mechanism to solve interpretation issues of the updated GB9706 Medical Electrical Equipment Standards.