Medical Product Registration in Other Asian Countries
Indonesia, Malaysia, the Philippines, and Thailand
Registration of Medical Devices in Other Asian Countries
Registration of Pharmaceuticals/Drugs in Other Asian Countries
The medical product regulators in these Asian countries include Malaysia's National Pharmaceutical Control Bureau (BPFK), Indonesia's National Agency of Drug and Food Control (NA-DFC), the Philippines' Bureau of Food and Drugs (BFAD), and Thailand's Food and Drug Administration (FDA). They have varying registration requirements for marketing medical devices and pharmaceuticals in their respective countries. Approval by the U.S. or EU will help expedite product registration in these countries. In some countries medical device registration is voluntary, such as Malaysia's MeDVER program. It is expected, however, that medical device approval will be required in the future.
Each country's product registration requirements have unique features and possible pitfalls. Additionally, the Association of Southeast Asian Nations (ASEAN) is devising standardized medical device dossier requirements under the Common Submission Dossier Template (CSDT). The CSDT is scheduled to be valid in Southeast Asia starting in 2010. The CSDT should make it much easier to get medical devices approved across the entire Southeast Asian region, since the same dossier can be prepared for each country.
PBM's expertise will help you navigate these regulatory systems, achieve medical product registration, and access these countries' medical markets. PBM will help you register your medical product in a cost-effective and timely way.
For more information on medical product registration in the other Asian countries, please see the following PBM publications and/or contact us to discuss your specific needs.
- Looking East for R&D and Clinical Trials
- ASEAN Medical Device Harmonization Trends (webcast for sale)
- A Regulatory Update on Asia's Smaller Medical Device Markets
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