Hainan Island’s Special Access Program for Medical Devices
On May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices.
On May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices.
In March of 2024, the CMDE added 25 devices to the “Guidelines for Deciding Whether to Conduct Clinical Trials on 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.
The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.
Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
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.
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
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