Regulatory News from Across Asia-Pacific

China medical device registration review requirements have been updated by the NMPA and have undergone a comprehensive revision.

China medical device registration review guidelines were issued on September 15, 2022, for registrations, renewals, etc. for 27 products.

China’s vaccine regulator receiving the WHO recognition indicates that vaccines produced from the country ensures quality, safety and effe...

NMPA medical device standard modifications were issued and came into effect on September 7, 2022, with 92 recommended standards transformed

The medtech, cosmetics and pharmaceutical webinars will cover important China regulatory updates presented by our Cisema regulatory experts.

ICH Q13 guidelines were referred by China’s Center for Drug Evaluation to draft guidelines on continuous manufacturing for oral solid dosages

The Real-World Evidence draft guideline aims to improve the communication between applicants and the reviewer for drug registrations in China.

Hong Kong listing of medical device under some conditions will gain an edge in public procurements carried out by the Department of Health.

China cosmetics registration certificates for special cosmetics and new cosmetic ingredients will be issued electronically from Oct. 1, 2022

NMPA has issued draft measures for the supervision and administration of China cosmetics online operations

The China CAC issued new measures on cross border data transfer for medical devices coming into force on September 1, 2022.

Quality assurance in purchasing China products provides a cost advantage to foreign buyers, yet there are still some barriers to overcome.

ICH E8 (R1) General Considerations for Clinical Studies will be applied in China in July 2023 together with E14 Clinical Evaluation of QT/Q...

China cross border data transfer security assessments new measures have been issued by the Cyberspace Administration of China (CAC)

"Made in China" current regulatory trends & requirements for medtech industry will be presented in this webinar held by MedicalMountains GmbH

"Regulatory Requirements for Medical Devices in China" is the second webinar of a two-part webinar series held together with SPECTARIS GmbH.

The webinar "Challenges for China Registration of API" informs you about the current requirements in China, and compare between EU and China.

China class I medical device filing, and also IVD reagents, related matters have been clarified by the NMPA on August 12, 2022.

China medical device clinical evaluation terms and definitions are open for industry stakeholders’ comments, also for IVD clinical trials.

China GB/T 9254.1-2021 emission requirements for EMC (electromagnetic compatibility) came into force on July 1, 2022.