Medical Product Registration in Taiwan
Registration of Medical Devices in Taiwan
Registration of Pharmaceuticals/Drugs in Taiwan
Product registration in the Taiwan is difficult, but is somewhat easier than Japan. In some cases, U.S. or E.U. approvals can be substituted for local requirements. Also, the government has recently been overhauling the approval system with an eye towards making it quicker and more efficient.
The chief Taiwanese regulator of medical devices and pharmaceuticals is the Bureau of Pharmaceutical Affairs (BPA) under the Department of Health (DOH). The BPA must approve all pharmaceuticals and medical devices imported to Taiwan before they can be marketed. The separate Bureau of Food and Drugs Analysis (BFDA) handles technical review for Class II and III medical devices, while the independent Center for Drug Evaluation (CDE) handles technical review for Class I medical devices and drugs.
Companies interested in registering their pharmaceutical/drug in Taiwan must keep in mind that a Plant Master File (PMF) needs to be submitted prior to submitting a drug registration application. The PMF is per site and describes the layout of the manufacturing site, validation processes, etc. Once this is completed, the applicant can submit the product registration dossier.
PBM's expertise will help you navigate the Taiwanese regulatory system, achieve medical product registration, and access Taiwan's 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 Taiwan, please see the following PBM publications and/or contact us to discuss your specific needs.
- Taiwan Drug Registration and Regulatory Issues (webcast for sale)
- Looking East for R&D and Clinical Trials
- A Regulatory Update on Asia's Smaller Medical Device Markets
- Updates on Taiwan's Medical Device Market (webcast for sale)
- Taiwan Medical Device Regulations Presentation (webcast for sale)
- Taiwan: An Update for Medical Device Product Registration
- Taiwan: New Pharmaceutical Regulatory Trends
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