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
Malaysia’s Ministry of Health (MOH) has been working for several years on gradually establishing a medical device registration system. In February 2005, they announced the Medical Device Voluntary Establishment Registration program, abbreviated MeDVER. Implemented in January 2006, this is a system where... 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
Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.... 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
Counterfeit drugs are a big problem in Asia. Somewhat lax enforcement of drug patents and the high cost of brand name drugs have generated huge demand for (and supply of) cheap imitation drugs. In some Asian countries, up to one-half of available... Read More
In February 2005, the Malaysian Government decided to begin regulating medical devices. This new regulatory system for medical devices will be in accordance with the regulatory requirements of the Global Harmonization Task Force, World Health Organization, and World Trade Organization. The first... Read More
A draft of Malaysia’s Medical Device Bill has been completed and submitted to the Attorney General for review, according to a statement made by Malaysian Minister of Health Dr. Chua Soi Lek in September 2005. One of the requirements in the proposed... Read More