News

China innovative medical devices special review results have been announced by the NMPA on October 18, 2024.

China pediatric drugs encouraged for R&D – fifth batch have been announced by the NHC and other 3 organizations on August 30, 2024.

China NMPA has announced a suspension of import, sale and use of laser surgery equipment manufactured by Jeisys Medical Inc.

China Fire Safety Products Compulsory Certification rules were revised and released by the National Certification and Accreditation.

Micro-volume syringe priority review application has been announced by the Center for Medical Device Evaluation on October 18, 2024.

The NHC approved 12 China new food raw materials. This regulatory update outlines safety assessment, production and usage for the substances.

Absorbable hemostatic product and other 11 medical devices registration review guidelines have been revised and published by China's CMDE.

Four new substances were added to the China Health Food Dual-Use Substances Catalogue on August 26, 2024, including Citrus Grandis Tomentosa.

A trial program for the online submission of China drug registration application documents started on July 1, 2024.

The results of China’s latest round of medical device inspection were published by China’s NMPA on 11 September 2024.

InvestHK recently invited Cisema to share regulatory insights at their seminar event, highlighting opportunities in Hong Kong and GBA.

China’s CMDE has published medical device real-world data terms and definitions in draft format for industry comments by October 8, 2024.

China’s NMPA has released a draft Medical Device Administration Law to replace the current China Medical Device Regulations.

China’s CDE has issued a draft document titled “Q&A on Clinical Trial Requirements for Drugs Listed Outside China and Not Listed in China.”

South Korean company, GP Club Co., has failed an unannounced inspection by China’s Center for Food & Drug Inspection under the Cosmetics GMP.

China’s Cosmetic Labeling Requirements came into force in May 2022. In this article we provide an overview for cosmetic manufacturers who want to enter the Chinese cosmetic market.

China’s SAMR introduces China Compulsory Certification (CCC) Requirements for Gas-Burning Appliance Safety Accessories from October 1, 2025.

China’s NMPA has issued the requirements for the Temporary Import of Class II and Class III Medical Device for Urgent Clinical Need.

New Greater Bay Area regulations for importing Hong Kong drugs and medical devices starting December 1, 2024 will reduce review time

Hong Kong - Greater Bay Area Deep Dive will be an hour webinar focusing on sharing insights to leverage the GBA pathway effectively.