China CMDE Supplementary Documents Submission Deadline Extended
On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.
A list of recently published articles regarding medical device regulatory updates from the NMPA and other governing bodies in China.
Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
/in China, India, Japan, Latest Updates, South Korea, Taiwan, United States/by Albert PranotoAn outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
China Continues to Implement UDI of Medical Devices with Third Batch Release
/in China, Latest Updates/by Bryan GilburgThe NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
How New EU MDR Requirements Will Affect Registrations in Asia
/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan GilburgAs manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
China NMPA Updates Compulsory Standards for Medical Devices
/in China, Latest Updates/by Bryan GilburgOn November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.
China NMPA Updates Classification of Sodium Hyaluronate Products
/in China, Latest Updates/by Bryan GilburgOn November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
China Releases Draft Clinical Evaluation Exemption List for 2022
/in China, Latest Updates/by Bryan GilburgOn July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.
China’s NMPA Publishes Classification Catalogue Adjustments for Comment
/in China, Latest Updates/by Bryan GilburgOn October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
Medical Device Advertising Requirements in Asia
/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan GilburgIn addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
China’s NMPA Begins Issuing Registration Certificates Electronically
/in China, Latest Updates/by Bryan GilburgOn October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
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