Discussions on Medical Device Regulations in Thailand

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, 2008 on Thailand’s adverse event reporting system. With attendees from both the government and industry, the meeting discussed post-market vigilance requirements based on international medical device controls.

It also provided a framework for the planned harmonization efforts of ASEAN with its Safety Alert Dissemination System. In addition, the ASEAN Consultative Committee for Standard and Quality Product Working Group on Medical Devices recently held its 8th meeting July 15 to 17, 2008, with workshops on product registration systems and medical device controls to standardize patient safety.

The Thai FDA also recently attended a workshop to determine how best to control medical product advertising. All medical product advertising needs to be submitted to the Thai FDA for approval before being published or aired. However, the Thai FDA has found numerous cases of misleading and exaggerated claims in unapproved healthcare product advertising. The Thai FDA has formed an alliance with consumer groups to set up a network monitoring medical product advertising more strictly.