Archives
Asia Now Outpaces the West in the Number of Drug Clinical Trials
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
Medical Device Registration in Singapore will Lead to Expedited Approval in Thailand
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
Thailand Medical Device Approval Process Has Been Simplified With The Removal of the Pre-submission Step
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 device approval had to provide basic information about the product and wait for the TFDA’s response to determine its specific grouping and classification. However, today with the... Read More
Thailand Establishes Fast Track To Approval Of Class 4 Medical Devices
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
2021 Asia MedTech Update – Taking Your Medical Device Products to the Asia Pacific Markets
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
Moving to Bolster Safety, Thailand Establishes New Quality Standards for Pharmaceuticals
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
Thailand Puts in Place Strict Guidelines for the Management of Medical Device Product Recalls
Pushing to bolster the safety and efficacy of medical devices sold in Thailand, the country’s regulatory authority has set out new guidelines on when and under what circumstances a recall is appropriate for devices whose continued presence in the market could affect... Read More
Across Asia, Market Opportunities Emerge for Fast-Growing Direct-to-Consumer Genetic Testing Industry
The viability of marketing home-use genetic collection kits to consumers in Asian markets is growing, bolstered by government incentives, increased consumer awareness of their own healthcare needs and improvements in the technology behind the kits themselves. The kits employ state of the... Read More
Thailand Adopts Tough New Rules for Medical Device Approvals Based on ASEAN Metrics
Licenses to sell medical devices in Thailand will be more difficult to obtain under a rigorous new system of regulations issued in February by the Food and Drug Administration of the Southeast Asian country. The new rules are in line with the... Read More