News

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.

Innovative provisions for cosmetics in Pudong, Shanghai aims to enable customizable product packaging, optimize the route-to-market, etc.

China GB 4943.1-2022 safety requirements aims to improve the product’s level of safety and security from pre-market to post-market.

Cosmetics GMP Good Manufacturing Practices came into force in China on July 1, 2022. Contact Cisema to see if it affects your production.

China Vaccine Production and Distribution Rules were released by the NMPA on July 8, 2022 and came into effect immediately.

China’s NMPA has issued Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices

China drug real-world study design and protocol framework guidelines (draft) for comments will be open until September 7, 2022.

Contract manufacturing of Hong Kong medical device and drug in GBA is supported by China NMPA's implementation plan announced in June 2022