Regulatory News from Across Asia-Pacific

OEM prohibited medical devices means original equipment manufacturers (OEM) are banned from production in China for certain medical devices.

Medical device classification catalogue changes to non-sterile liquid/paste dressings, neurological/cardiovascular surgical instruments

Supervision of medical device distribution in China will be strengthened when the new regulatory measures take effect on May 1, 2022.

Supervision of medical device manufacturing in China will be strengthened when the new regulatory measures comes into effect on May 1, 2022.

The China Clinical Trials GCP (Good Clinical Practice) 2022 amended version will come into effect on May 1, 2022.

China GB 16897 for brake hoses and tubes of vehicles (automobile, motorcycle and trailer) was proposed for implementation on July 1, 2023.

China NHC announced the approval of 2 new food ingredients, 11 new food additives, and 19 new food-related product varieties.

Measures for Cosmetics Adverse Reaction Monitoring consists of 7 chapters covering general provisions, adverse reaction investigation, etc.

Importing drugs and medical devices from Hong Kong have been approved and amounted up to 15 products into the GBA as of March 2022.

2022 sampling inspection plan covers 60 products mainly targeting IVD reagents, anti-epidemic medical supplies, etc.

The NMPA report on China medical device standards management provided a comprehensive overview of the past year’s developments.

China issued digital health regulatory guidelines for registration of medical device software including AI, and for cyber security.

China general cosmetics urgent deadline is 31 March every year as part of CSAR's framework to file an annual report to the NMPA

Cisema Webinar on Cosmetics Registration explains ins and outs of filing/registering cosmetics products as the CSAR takes over the old CHSR

Clinical trials GMP management specification first issued its draft in July 2018. The appendix draft was issued on January 18, 2022.

Acceptance and examination of chemical APIs trial guidelines have had its first draft issued in April 2020.

Medical device product technical requirements have new guideline issued by the China NMPA on February 9, 2022.

The NMPA reported a total number of 12,255 applications and 11,314 approvals for medical device and IVD registrations in 2021.

In order to restrain the illegal use of drug ingredients in medical dressing patches, the China NMPA approved the testing methods propose....

China Medical Device Standards have been recorded with a total of 1,849 as of December 2021, whilst 181 standards were newly issued in 2021.