Regulatory News from Across Asia-Pacific

China’s NIFDC recently issued five technical guidelines on China cosmetic ingredients’ acute inhalation toxicity test ranging from experimental research to 28-day repeated dose tests.

China’s NMPA has recently released an update to the recommended clinical evaluation pathways for medical devices that are listed in the China Medical Device Classification Catalogue.

Hong Kong MDACS listing now accepts medical devices approved by Singapore HSA, with online submissions available starting April 15, 2024

China’s Center for Drug Evaluation has released its annual report for 2023.

China customs clearance requirements, with a focus on CCC and trade logistics, will be covered in the upcoming webinar on June 25, 2024

China’s SAMR has issued amendments to Special Equipment Production and Filling Licensing Regulations. They come into effect on June 1, 2024.

NMPA overseas factory inspection results have seen at least three medical device manufacturers notified by the authorities this week alone...

China CCC certificates and CCC marks have new implementation requirements, including electronic certificate formats

GB9706 series standards status update has been released by the National Institutes for Food and Drug Control (NIFDC) on January 19, 2024.

China electric bicycle certification implementation technical resolution has been issued by the China Quality Certification Centre.

China medical device industry standards have a new list released on February 19, 2024, with some being revised for implementation as well.

China Greater Bay Area demand for medical products surges as Guangzhou customs supervised over 101 batches of imported products in 2023...

China’s NMPA has released its annual report for medical device standards management for 2023. There are now 1,974 standards.

China medical device registrations 2023 annual report has been issued by the NMPA.

Cisema will give a presentation with Forum to talk about the medical device Market Potential and Product Approval in China on June 4-5, 2024.

Webinar: Medical Device Pathways to Market for China on February 15, 2024. This will help you understand the right way for your products.

Real-world evidence research design and statistical analyses guideline has been released by China’s Center for Medical Device Evaluation.

Triethanolamine in low concentrations no longer needs a dual use import license for China and will come into effective from February 1, 2024.

Webinar: Medical Device Pathways to Market for China on February 15, 2024. This will help you understand the right way for your products.

China’s Institute of Veterinary Drug Control has released draft Aquaculture Drug Efficacy Trial Technical Guidelines for industry comment.