Medical Devices

The NMPA issued guidelines to address the standard procedure of submitting risk evaluation reports after the occurrence of adverse events.

The CMDE shared a timeline of events for establishing regulatory control on AI medical devices and shared the latest status of their upcoming plans.

The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.

China’s NMPA issues technical guidelines (trial) for utilizing real-world data (RWD) in the medical device clinical evaluation process.

Following the launch of the China’s national UDI system, the Hainan MPA has announced a pilot plan for the UDI system in Hainan with a larger product scope.

The draft guidelines cover real-time fluorescent PCR analyzers, disposable non-absorbent closure clamps, nanomaterials, and intravascular catheters

Industry requirements, evaluation methods and testing guidelines cover bone implants, medical imaging devices, SaMDs, surgical equipment, test kits, etc.

The NMPA announced 6 principles to strengthen the market surveillance of coronary stents following the centralized procurement process

The CMDE prepared a brief analysis as reference for manufacturers planning to register their drug-device combination products in China

During the past month, the NMPA and CMDE were actively involved in facilitating the fast-track approvals for medical devices in the Chinese market.

Once the sampling inspection procedures in the recent draft amendment is finalized, the NMPA Legal Agents will play a more important role.

NMPA’s recent release of the updated product information of 29 IVD reagents, primarily to down-classify from class III to class II, was long overdue.