A list of recently published articles regarding medical device regulatory updates from the NMPA and other governing bodies in China.

China NMPA Updates Compulsory Standards for Medical Devices

On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.

China NMPA Updates Classification of Sodium Hyaluronate Products

On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.

China Releases Draft Clinical Evaluation Exemption List for 2022

On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

China’s NMPA Publishes Classification Catalogue Adjustments for Comment

On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.

Medical Device Advertising Requirements in Asia

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

How New EU MDR Requirements Will Affect Registrations in Asia

As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

China’s NMPA Begins Issuing Registration Certificates Electronically

On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.

China Fully Implements UDI Requirements for Class 3 Medical Devices

Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.

China Issues Recommendation for Medical Device Clinical Data

For medical device registration in China, one of the most important documents to be provided is  clinical data.