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 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.
China’s NMPA Begins Issuing Registration Certificates Electronically
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE
Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.
Submission Changes in China: ToCs and the eRPS
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.