Medical Devices

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

NMPA overseas factory inspection results have seen at least three medical device manufacturers notified by the authorities this week alone...

GB9706 series standards status update has been released by the National Institutes for Food and Drug Control (NIFDC) on January 19, 2024.

China medical device industry standards have a new list released on February 19, 2024, with some being revised for implementation as well.

China Greater Bay Area demand for medical products surges as Guangzhou customs supervised over 101 batches of imported products in 2023...

China’s NMPA has released its annual report for medical device standards management for 2023. There are now 1,974 standards.

China medical device registrations 2023 annual report has been issued by the NMPA.

Cisema will give a presentation with Forum to talk about the medical device Market Potential and Product Approval in China on June 4-5, 2024.

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.