Regulatory News from Across Asia-Pacific

Intense pulsed light therapy device registration in China shall refer to the newly revised technical review guidelines issued in April 2023

China motorcycle rearview mirror and helmet standard requirements - GB 15084-2022 and GB 811-2022 will come into effect on July 1, 2023.

Clinical trials of sodium hyaluronate complex solution have a set of draft guidelines issued by the China CMDE on May 17, 2023.

China registration of ophthalmic optical measurement devices shall refer to the respective technical review guidelines issued by the CMDE

Pre-communication for Hainan medical device clinical RWD applications will be required to follow the CMDE trial measures.

The registration platform for cosmetic raw materials safety information in China helps ensure that businesses fulfill their responsibilit...

Technical guidelines for reporting cosmetics formulas were drafted by the National Institutes for Food and Drug Control.

Submission of safety information for cosmetics raw materials will soon be standardized according to the CSAR and Measures for the Admin...

This webinar provides insights on how to avoid animal testing in China for cosmetics and stay compliant with local regulations.

Guidelines for medical device registration in China have new development plans released in April 2023 - 108 will be implemented and revised

"China DMF of API, Excipient & Packaging Materials: Market & Regulatory" will be an hour webinar session covering the process and trends...

Pre-Phase III drug clinical trial meeting guidelines have been released by the NMPA CDE for trial implementation as of March 22, 2023.

China’s Center for Drug Evaluation has released new Guidelines for Information on China Chemical Drug Instructions and Labels.

China medical device market eRPS data error correction matters will be incorporated into the business scope on April 20, 2023.

China medical device sampling inspection plan for 2023 covers 68 products including electronic endoscopes, medical oxygen concentrators etc.

China radio frequency beauty devices have new technical review guidelines issued to ensure that products are safe and effective

China’s NMPA issues further explanations on how to interpret and implement GB9706.1-2020 standards for medical electrical equipment

China releases a whitepaper on its AI medical device market. The AI medical device industry is becoming a new growth driver.

Oral solid dosage continuous manufacturing technical guidelines have been issued by the China CDE on Mar. 21, 2023, for trial implementation

Ultrasound soft tissue surgical equipment in China have new technical review guidelines amended for registration dossier preparation