The Thai Food and Drug Administration (FDA) recently implemented a new phase of its Medical Device Act. This phase is the transfer of some regulatory powers to the provincial governments. Thailand’s new Medical Device Act went into effect in 2008, overhauling Thailand’s... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
Thailand’s Food and Drug Administration (FDA) has recently held meetings to discuss methods of improving supervision of post-market surveillance and medical product advertising. The Medical Device Control Division of the Thai FDA held a seminar in Bangkok on June 3rd and 4th,... Read More
Thailand’s Food and Drug Administration (FDA) has recently implemented a new law, Medical Device Act B.E. 2551, to replace Medical Device Act B.E. 2531. This new Act details regulations and requirements for product registration, advertisements, and punishments for non-compliance. The Act defines... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
Thailand’s Public Health Minister Chaiya Sasomsab has announced his decision to push forward with compulsory licensing for drugs. Despite protests from industry members such as the Pharmaceutical Research and Manufacturers Association (PreMA) to implement this decision, Chaiya plans to push forward on... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
As a member economy of the Asian-Pacific Economic Cooperation (APEC), Thailand will be hosting a workshop as part of APEC’s “Capacity Building for Drug Regulatory Agencies on Clinical Trial and Good Clinical Practice” on March 17-21, 2008. Thailand proposed this project to... Read More
This month, Thailand’s Ministry of Public Health announced a new national drug list with lower prices for drugs treating cancer, glaucoma, and anemia. In accordance with this revised drug list, the Ministry has pushed for pharmaceutical firms to reduce cancer drug pricing... Read More