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
The World Health Organization (WHO) and various international partners came together in Germany November 2006 to develop a task force focused on preventing the global spread of counterfeit medicines. The International Medical Products Anti-Counterfeiting Taskforce, or IMPACT would cover legal, technological, communications... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More
The Indonesian Health Minister has set a deadline of August 2006 for full compliance with a ministerial decree regarding drug labeling requirements. Ministerial Decree 68/2006 requires drug companies to print generic names and retail prices on packaging for all branded drugs. The... Read More
The pharmaceutical market in Indonesia is currently valued at around $350 million. More than 50 percent of the market is comprised of imported products, with a large portion coming from the U.S., Germany, Switzerland and Japan. Foreign companies importing finished products or... Read More
The ASEAN (Association of Southeast Asian Nations) Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 by the ASEAN Economic Ministers. The purpose of the committee is to eliminate technical barriers to trade and facilitate the objectives of the ASEAN... Read More
Many regulatory authorities in Asian countries are choosing to allow medical device product registration submissions to be done in electronic form. Previously, all governments required product registration applications to be completed in paper form, however, technical advances and the advent of a... Read More
As Asian countries begin to adopt more western lifestyles and foods, “western” diseases are becoming more prevalent killers in Asia. Economic transition, urbanization, and technological development have brought about lifestyle changes that have increased the chances for heart disease in Asia. Developing... Read More