Taiwan Medical Device Regulatory Updates

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.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

October 25, 2022/in China, India, Japan, Latest Updates, South Korea, Taiwan, United States/by Albert Pranoto

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

Medical Device Advertising Requirements in Asia

July 22, 2022/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan Gilburg

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

How New EU MDR Requirements Will Affect Registrations in Asia

August 12, 2022/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan Gilburg

As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

Asia Actual is the Best Medical Device Consulting Company in Asia

February 24, 2022/in Australia, China, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Todd Daigneault

Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

Taiwan FDA Increases Regulatory Fees for Medical Devices

May 13, 2021/in Latest Updates, Taiwan/by Eric Leung

The Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.

Taiwan FDA Launches New ePortal for Medical Device Applications

Taiwan FDA Medical Device Advertising Requirements

Taiwan’s New TCP III in Effect as of January 1, 2022

UDI Labelling Mandatory for Certain Taiwan Medical Devices

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

How New EU MDR Requirements Will Affect Registrations in Asia

Asia Actual is the Best Medical Device Consulting Company in Asia

Taiwan FDA Increases Regulatory Fees for Medical Devices

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