Currently, if you want to sell your medical device into Southeast Asia--a region with a combined population of nearly 600 million people -- you need to contend with wide regulatory variations. Thailand, Indonesia, the Philippines, and Vietnam generally require that devices be registered according to their own national systems. In Singapore and Malaysia, registration is voluntary, but it will become mandatory in the near future. Dealing with all of these systems can be complicated. However, within a few years, it will become much easier to introduce a product into all of Southeast Asia with the introduction of the ASEAN Medical Device Directive (AMDD).
The AMDD is a region-wide commitment by the Association of Southeast Asian Nations (ASEAN), and is in the final stages of planning by a working group with representatives from all ASEAN health ministries. It would essentially standardize medical device registration requirements and procedures among all 10 ASEAN members. If all goes as planned, the ASEAN countries will put the AMDD into effect between 2010 and 2015 (depending on the country). ASEAN's more-developed countries such as Singapore and Malaysia would act first. In fact, Singapore passed legislation in 2007 that implements the AMDD's requirements over time.
Under the AMDD, there will be a common template for submitting devices to regulatory bodies for approval in each ASEAN country. The Common Submission Dossier Template (CSDT) reflects international norms for device registration, as codified by the Global Harmonization Task Force (GHTF), with a few minor differences.
The AMDD does not mean a single regulatory approval would enable marketing a product in every ASEAN country (which makes it unlike the EU's medical devices directives). It would mean, however, that applicants can prepare a single regulatory dossier and submit almost identical copies to each ASEAN country. Over time, as the AMDD is implemented, device manufacturers may come to treat Southeast Asia as a single market, at least for purposes of regulatory strategy.
Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device and Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is a frequent contributor of articles on Asian medical issues for Clinica (UK), MD&DI (Los Angeles), and other medically oriented journals. Gross has been a featured speaker on the Asian medical markets at the Medical Design & Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society's annual and regional meetings, and a variety of other medically oriented meetings and conferences. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm's Web site at www.pacificbridgemedical.com.