Medical Device Advertising Requirements in Asia

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

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.

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

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

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

The 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

The 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

The 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

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.