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.
A list of recently published and updated articles regarding medical device regulatory updates from the TFDA and other governing bodies in Taiwan.
Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
/in China, India, Japan, Latest Updates, South Korea, Taiwan, United States/by Albert PranotoAn outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
How New EU MDR Requirements Will Affect Registrations in Asia
/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan GilburgAs 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.
Medical Device Advertising Requirements in Asia
/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 GilburgIn 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.
Asia Actual is the Best Medical Device Consulting Company in Asia
/in Australia, China, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Todd DaigneaultManufacturers 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’s New TCP III in Effect as of January 1, 2022
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Taiwan FDA Medical Device Advertising Requirements
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
Taiwan FDA Launches New ePortal for Medical Device Applications
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
Taiwan FDA Increases Regulatory Fees for Medical Devices
/in Latest Updates, Taiwan/by Eric LeungThe 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.
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