Medical Devices

China medical device adverse event monitoring report for 2021 shows 21% increase over the previous year with over 650 000 events reported...

NMPA clinical trial pathway for medical device categories cover ophthalmic, radiation therapy, medical imaging, cardio-vascular surgical, etc.

Medical device naming rules for China have been added from 16 to 22 guidelines by the NMPA on June 2, 2022.

China’s NMPA has issued draft guidelines on medical device QMS audit for product registration, and open for comments until June 27, 2022.

China’s NMPA is now accepting comments on the draft of "QMS requirements for 3PL for Medical Devices in China" until June 20, 2022.

NMPA solicits comments on the revised draft of China's medical device classification for sodium hyaluronate products until June 16, 2022.

Interested in the recommended paths for China medical device clinical evaluation? Contact Cisema regulatory affairs consultancy & CRO

China YY Standards 2022 Implementation and Amendment Plan covers 59 new YY/T standards and 57 existing industry standards to be amended.

"China GMP Medical Device 2022 Edition for sterile and implantable devices" by Beijing MPA replaces the 2016 edition with immediate effect.

The Communication SOP for Medical Device Clinical RWD Applications (Trial) was jointly issued by the CMDE and the Hainan MPA in April 2022.

China clinical application management is an important part of the modern hospital management system to standardize medical technologies.

OEM prohibited medical devices means original equipment manufacturers (OEM) are banned from production in China for certain medical devices.