Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More
Taiwan’s Legislative Yuan passed the “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations” on June 4, 2024. These laws, collectively known as the “Regenerative Medicine Dual Acts,” were ratified by the President on June 19, 2024. They aim to establish a rigorous... Read More
On November 27, 2023, Taiwan issued an amendment to the – Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration. Medical device registration in Taiwan includes two separate applications – 1. a dossier on the product and 2. a Quality... Read More
This article was originally published on MedTech Intelligence. Companion diagnostics (CDx) plays a pivotal role in personalized medicine—one of the fastest-growing areas of medicine. Regulation of CDx is fairly well established in Western countries, but the East is not far behind. Here... Read More
Taiwan is Asia’s 6th largest drug market with many Western drug companies selling their products there. However, similar to many other drug markets around the world, Taiwan wants to reduce drug prices and government health expenditures. Accordingly, in mid-September, Taiwan’s National Health... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
Contact us today for a free consultation with a Taiwan regulatory affairs consultant to discuss your specific needs. History and Overview The Taiwan Food and Drug Administration (TFDA) was established on January 1, 2010. The establishment of the TFDA followed the enactment... Read More