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

China’s NMPA Publishes Classification Catalogue Adjustments for Comment

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

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 to Require All Electromedical Devices Meet Updated Standards

This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

China to Implement New Electrical Safety Standards for Medical Devices

An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.

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 Publishes 9 Draft Guidelines for Registration of Medical Devices

Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.

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.

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 to Accept Foreign Generated Test Reports

This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.