News

Microbial limits for non-sterile chemical drugs, API and excipients were released in a new set of guidelines by China's CDE in Feb 2023

China’s Medical Device Supplementary Notice Period reverts to 1-year period from previous 2-year temporary extension, commencing Feb 20, 2023

New registration review guidelines have been issued by China’s CMDE for dental adhesive products for dental filling and restoration, as well as restoration and bonding.

China’s Toothpaste Supervision & Administration Regulation is announced by the SAMR, and will come in effect from Dec 1, 2023, onwards

Expedited safety reporting in drug clinical trials is required for applicants to timely inform the CDE about any SUSAR events

Cisema announces Hamish King as new CEO bringing over 10 years' experience in the legal and regulatory fields...

China medical device standards management 2022 annual report was issued on February 8, 2023, to provide an overview of standards development

Medical device registrations China 2022 Annual Report shares an overview of the 11,942 medical devices successfully registered over the year

China UDI medical device third batch implementation date is June 1, 2024, as part of the continuing drive to improve supervision and...

CCC electronics self-inspection pilot work was announced on January 9, 2023, to help streamline work processes of the government and...

China motorcycle and brake hose regulatory updates have been released by the China SAC and the CQC respectively.

Medical Device Master Files in China were introduced in 2021 but the NMPA has clarified their use for the registration of medical devices

China general cosmetics filing and inspection measures are updated by the NMPA to allow for manufacturers for self-testing and inspection...

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.