Regulatory News from Across Asia-Pacific

China special equipment production unit responsibilities for quality and safety shall be fulfilled once the SAMR provision is in effect

China medical device quality and safety responsibilities have seen new proposals issued by the NMPA recently

China food production licensing rules and principles have been updated by the SAMR and took effect on November 1, 2022.

China's digital health regulatory framework for SaMD has been evolving with several key legislations implemented over the years by the NMPA.

Changes during China drug registration shall refer to the working procedures issued by the Center for Drug Evaluation on November 11, 2022.

China medical device registration electronic certificates have the same legal effect as the paper version of the registration certificate.

China IVD Reagent Registration and Review Guidelines have been recently updated. Six guidelines came into effect on September 28, 2022.

China cosmetics registrations FAQS October 2022 covers raw materials, labelling, DRA powers of attorney etc.

China medical electrical equipment will be subject to the new standard GB9706.1 from May 1, 2023, onwards.

China drug registration electronic certificates will be issued by the NMPA from Nov. 1, 2022, onwards, for various drug-related applications

Medical device QMS verification guidelines have been updated to assist with the China medical device registration process.

China personalized cosmetics services pilot run will be carried out by the Beijing, Shanghai, Zhejiang, Shandong and Guangdong MPAs

The China medical device mandatory standards list is updated and the CMDE addresses the medical device certificate holders's responsibilities

CMDE Platform for AI Medical Device in China carried out a closed-door meeting and 17 working groups presented their 2022 3rd quarter reports

China medical device classification results for 388 applications have been announced; Latest catalogue amendment draft proposed 57 changes...

China Compulsory Certification list update in October 2022 means CCC is no longer mandatory for 9 product categories

As part of its supervision and administration of medical devices, China undertakes sampling inspections - 12 products failed recently.

China has introduced a new Catalogue on the Import and Export of Endangered Species to implement its commitment to CITES.

China’s SAMR issued new measures regulating the safety supervision and inspection of special equipment in China

A Cosmetics Adverse Reaction Monitoring System has been launched in China to strengthen & improve the efficiency of monitoring nationwide