ABSTRACT
The medical device industry in the Philippines is almost totally dependent on imports with local medical device manufacturers represent only <3% of the market. The principal medical device regulatory authority in the Philippines is the Food and Drug Administration (FDA), under the auspices of the Department of Health (DOH). The Philippines is one of ten members of the Association of Southeast Asian Nations (ASEAN). Bureau of Health Devices and Technology (BHDT) is representing the Philippine medical device sector at meetings of the ASEAN Consultative Committee on Standards and Quality-Medical Device Product Working Group (ACCSQ-MDPWG), which has met fifteen times over the past eight years, most recently in Phuket in April 2012. The working group is focusing on three main activities: a comparative study of medical device regulation across all ASEAN countries; developing an ASEAN Common Submission Dossier Template; and formulating a Post Market Alert System for unsafe and defective devices.
