Tag Archive for: Medical Device

Philippines Incentivizing Local Medical Device Manufacturing

/in , /by

On March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.

Read more

China’s Third Batch of UDI Implementation Deadline in June

/in , /by

Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.

Read more

China NMPA Updates Compulsory Standards for Medical Devices

/in , /by

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.

Read more

China NMPA Updates Classification of Sodium Hyaluronate Products

/in , /by

On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.

Read more

UDI Labelling Mandatory for Certain Taiwan Medical Devices

/in , /by

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.

Read more

Vietnam Adjustments to the Medical Device Application Requirements 

/in , /by

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.  

Read more

China Continues to Implement UDI of Medical Devices with Third Batch Release

/in , /by

The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.

Read more