China’s Third Batch of UDI Implementation Deadline in June
Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
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Hong Kong MDD Adds China and Korea to List of Reference Countries
Starting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
China’s NMPA Updates Medical Device Classification Catalogue
China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
China NMPA Adds 47 Products to Clinical Trial Exemption List
China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
China to Regulate Medical Device Advertising
China is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.
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.
China Continues to Implement UDI of Medical Devices with Third Batch Release
The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
China NMPA Updates Compulsory Standards for Medical Devices
On 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
On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
China’s NMPA Publishes Classification Catalogue Adjustments for Comment
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.