1. Overview The Thai Food and Drug Administration (Thai FDA) is responsible for safeguarding the well-being of consumers, particularly by guaranteeing the safety, quality, and effectiveness of various health products under its jurisdiction. Important matters are determined by committees comprised of experts... 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
Market Authorizations (MAs) for drugs in Thailand before 2019 never expired. With the implementation of the 2019 Thai Drug Act, drug MAs were only good for 7 years but could be renewed. Now, the Thai Drug Act has set out a detailed... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
The Thai FDA will now evaluate device approval more efficiently if the device has been already approved in Singapore. This also applies to Class B-D IVD’s approved in Singapore. Basically, the Thai FDA will reduce their review time from 150 to 60... Read More
In an effort to expedite the device registration process, the Thai FDA has ended the pre-submission stage of the Thai application process. Previously, applicants for Thai medical device approval had to provide basic information about the product and wait for the TFDA’s... Read More
Manufacturers seeking licenses to sell high-risk medical devices in Thailand will have a route to do so more rapidly and at less cost under a new agreement struck between regulatory authorities in the country and their counterparts in Singapore. Under the agreement,... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Seeking to bolster the safety of pharmaceuticals sold in Thailand, the country’s Food and Drug Administration (FDA) is imposing minimum standards established by the World Health Organization to ensure the quality and integrity of medicines throughout the supply chain. Under the Good... Read More