On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... 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
In a surprise move, Indonesia’s Ministry of Health issued a new regulation in November 2008 designed to force foreign companies to manufacture drugs in Indonesia. The regulation states that foreign-owned companies will not be allowed to register imported drugs for sale unless... 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
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
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
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality (ACCSQ-MDPWG) held a meeting from July 30 to August 2, 2007. In this meeting, the ASEAN (Association of Southeast Asian Nations) countries discussed proposals for conformity assessment... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries.... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing... Read More