Medical Devices

Human factors design for medical devices in China has draft guidelines revised and issued by the CMDE on October 10, 2023.

Clinical evaluation of laser therapy devices has new guidelines issued by the China Center for Medical Device Evaluation in July 2023.

Clinical evaluation of dental implant systems has new guidelines issued by the China CMDE on August 14, 2023.

China Medical Device Webinar will be featuring speakers from U.S. Embassy Beijing, U.S. Patent and Trademark Office (PTO), IQVIA, and Cisema

China's generative AI interim measures came into effect on August 15, 2023, after National Internet Information Office's approval in May 2023.

China medical device classification catalogue updates pertain to 58 categories of medical devices and encompass changes in product descrip...

The catalogue of medical devices exempted from clinical evaluation was recently revised by China NMPA and came into effect on July 24, 2023.

Third batch of illegal and non-compliant medical device online sales with 6 cases in total reported in China by the NMPA on August 4, 2023.

China medical device benefit-risk assessment guidelines have been revised and released by the CMDE on July 18, 2023.

Hong Kong medical device listing now attains full prominence in public tenders with measures effective from June 21, 2023, onwards.

Inspection report of Jiangxi Meilin Kangda Pharmaceutical in China was issued by the NMPA on July 19, 2023 with QMS concerns being reported.

Ultrasound AI and AI analysis software in China have four guidance documents released by the CMDE on July 10, 2023.