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
Do you want to bring your medical product to market in Southeast Asia? Pacific Bridge Medical’s regulatory compliance consultants can help you navigate Asia’s complex regulations and approval process.
While product registration requirements currently vary between these countries, measures are underway to streamline and standardize the medical device registration and approval process. Read on to learn more about these developments, and discover how PBM’s consulting team can help you take advantage of them.
Asia Medical Device Regulations Agencies
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.
Drug/Device Approval Requirements and the CSDT
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 Will Get Your Product onto the Asian Medical Market
PBM's Asian medical industry expertise will help you navigate these regulatory systems, achieve medical product registration, and access these countries' medical markets. PBM consultants will help you register your medical product in a cost-effective and timely way.
Rely on our medical experts to help you bring any number of medical products onto the Asian market, including:
- Drugs and Pharmaceuticals
- Medical Equipment and Devices
- Medical Instruments
- Medical Supplies
Contact PBM Today
Ready to get your medical product access to Southeast Asian markets? Contact PBM today to receive a free consultation with an Asian medical industry regulations expert.
Need more information? Browse the PBM publications listed below to learn more about healthcare industry regulations and opportunities in Southeast Asia.
Go back to the PacificBridgeMedical.com homepage
- 2011 Strategies for Success in China, Japan, and India
- 2008 Managing Asian Cultural/Business Diversity
- 2008 ASEAN Medical Device Harmonization Trends
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