Regulatory News from Across Asia-Pacific

China medical device standards February 2023 updates cover 33 mandatory and recommended standards for specific medical electrical equipment

Gas cylinder manufacturer digital code (three-digit number) will also be required for overseas (non-Chinese) gas cylinder manufacturers.

China medical device sampling inspection results no. 4 of 2022: Ten varieties of medical devices were sampled and inspected for quality...

NMPA Cosmetic Sampling Inspection will be standardized upon March 1, 2023 as the measures strengthen the supervision of cosmetics in China

China cosmetics quality and safety responsibilities have been introduced with new regulations by the NMPA coming into force on March 1, 2023.

China cosmetics efficacy claims FAQ is available to help answer cosmetics manufacturers and ingredient suppliers’ questions.

China cosmetics GMP inspection points and judgment principles came into force on December 1, 2023, to provide guidance to the industry.

China medical device quality safety responsibility regulations were issued by NMPA and will come into force on March 1, 2023.

China drug standards draft measures help ensure the safety, effectiveness and quality controllability of drugs in China

China special equipment safety supervision regulations are undergoing review by the State Administration for Market Regulation (SAMR).

China special equipment quality and safety responsibilities for production entities have draft provisions released by the SAMR.

Cisema 2023 events cover seminars, webinars, trainings, etc., to help manufacturers stay ahead of China regulatory developments

Cosmetics enterprises quality and safety responsibilities have been addressed in the draft regulation issued by the NMPA on Nov. 29, 2022.

Cosmetics adverse reactions collection and reporting draft guidelines for registrants and filers (trial) are formulated according to the CSAR

China cosmetics filing FAQs is a publication first issued by the Beijing Municipal Medical Products Administration (MPA) in November 2021.

Drug recalls in China now designate market authorization holders as the key responsible entity, and have a revised regulatory framework.

Electronic submission for China drug registration applications will be available from January 1, 2023, onwards.

China post-market surveillance regulations for medical devices in 2022 were being reviewed in a meeting carried out by the NMPA.

China UDI requirements will cover various class II medical devices manufactured after June 1, 2024, once the regulation comes into effect.

Regulation on safety supervision of special equipment in China had a new draft amendment issued by the China SAMR on November 30, 2022.