Regulatory News from Across Asia-Pacific

China’s NIFDC issued guidelines for the submission of cosmetics safety assessment information on April 30, 2024.

China’s NMPA has released the rules concerning Cosmetics Inspections in China. They come into effect on November 1, 2024.

China low voltage components CCC certification reinstated by the CQC and came into effect on May 1, 2024.

China Circuit Breakers for Equipment standard GB/T 17701-2023 has been released by SAMR and came into effect from April 2024.

China has released an IVD reagent classification catalogue. It was issued by the NMPA and includes all IVDS except those used for blood screening and those labeled with radionuclides.

China veterinary drug comparative test requirements have been revised by the MOA and this regulation will come into effect from December 1, 2024.

China’s SAMR issued technical requirements for the notification of Ginseng, American Ginseng, and Ganoderma lucidum.

China is making it easier to transfer registrations of drugs initially manufactured abroad to Made-in-China status to improve availability and accessibility to medicines.

China’s NMPA is introducing new supervision measures for the medical device entrusted production. This will come into effect on June 1, 2024.

Cosmetic Adverse Event Reporting guidelines for China have been released by the National Center for Drug Adverse Event Monitoring.

Regulatory Science for Pharmaceutical Innovation and Internationalization Conference took place on April 28, 2024, sharing GBA market insights

China CCAP Electric Vehicle Supply Equipment (CCAP-GZ-464230:2024) revised rules released by CCAP on March 27, 2024.

Measures to optimize cosmetic safety assessment management in China have been released by NMPA and come into effect on May 1, 2024.

China RF Therapy Device classification clarification has been published by the NMPA. This notice is subject to medical device legislation.

Usability engineering for medical devices registration in China Guidelines were released by the CMDE on March 19, 2024.

GB9706.1-2020 deadlines updated and released by NMPA for compliance, medical device manufacturers must comply with GB9706.1-202 standards.

China gas appliance CCC certification and other products have been announced and implemented by the SAMR on April 7, 2024.

China cosmetics stability evaluation and other 3 technical guidelines have been drafted for public comments by the NIFDC on April 10,2024.

China’s NMPA has released its medical device sampling inspection plan for 2024. Find out if your medical device is due for inspection this year by reading our article.

China’s NMPA released 15 toothpaste testing methods on March 21, 2024. These testing methods are required for the notification all toothpaste products in China from December 1, 2024.