Medical Devices

The NMPA issued a list of common violations committed by medical beauty service providers in China throughout 2020 and 2021.

Cisema presented on the topic of registration and approval of medical devices in China to 94 participants, and held a Q&A session after.

The NMPA published various technical guidelines covering specific topics on clinical trials, clinical evaluation, and animal testing.

Regulatory Measures for Self-testing finalized by National Medical Products Administration on October 22, 2022.

On October 29, 2021, the NMPA published the In Vitro Diagnostic Reagents Classification Rules for the first time as an individual document.

CMDE Drafted regulations for metallic implants using additive manufacturing and for dental implants and dentistry products

Technical review guideline for the clinical evaluation of Intravascular Catheters products in comparison with predicate devices was announced

On September 18, 2021, the China NMPA announced the implementation of a work plan to ensure product quality and safety for medical devices.

The CMDE released the draft of technical review guidelines for submission requirements of medical device clinical trial data.

Drug release studies may be required for combination products in China that intend to release drug components to certain parts of the body.

The NMPA announced the plan for the implementation of UDI for the remaining class III products which do not yet require UDI.

This is the first set of guidelines in China published specifically for nanomaterials used in medical devices in China.