News

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

China medical device registration review requirements have been updated by the NMPA and have undergone a comprehensive revision.

China medical device registration review guidelines were issued on September 15, 2022, for registrations, renewals, etc. for 27 products.

China’s vaccine regulator receiving the WHO recognition indicates that vaccines produced from the country ensures quality, safety and effe...

NMPA medical device standard modifications were issued and came into effect on September 7, 2022, with 92 recommended standards transformed

The medtech, cosmetics and pharmaceutical webinars will cover important China regulatory updates presented by our Cisema regulatory experts.

ICH Q13 guidelines were referred by China’s Center for Drug Evaluation to draft guidelines on continuous manufacturing for oral solid dosages

The Real-World Evidence draft guideline aims to improve the communication between applicants and the reviewer for drug registrations in China.