Tag Archive for: Medical Device

Vietnam Adjustments to the Medical Device Application Requirements 

Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, outlining the new guidelines for pre-market approval.  

UDI Labelling Mandatory for Certain Taiwan Medical Devices

In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.

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.