Taiwan continues to reinforce its position in global medical device regulation, as the Taiwan Food and Drug Administration (TFDA) has been re-elected to chair Working Group 3 (Pre-market: Software as a Medical Device – SaMD) under the Global Harmonisation Working Party (GHWP). This re-election is more than symbolic. It reflects sustained international confidence in Taiwan’s regulatory expertise, particularly in one of the most dynamic and technically complex areas of medical

In recent years, the field of regenerative medicine has garnered significant attention worldwide for its potential to revolutionise healthcare by repairing or replacing damaged tissues and organs. Taiwan, with its robust healthcare system and flourishing biomedical sector, is taking proactive steps to enhance its regulatory framework in this innovative field. Understanding the Dual-Track Framework Taiwan's dual-track framework is designed to balance both regulatory oversight

Starting on 1 July 2024, the Good Manufacturing Practise (GMP) Standards were implemented in the cosmetics industry, specifically for...

A new Medical Device Act was announced by the Taiwan Ministry of Health and welfare in November 2020 and has taken effect on 1 May 2021....