Regulatory Strategy in Taiwan
Regulatory Strategy for Medical Devices in Taiwan
Regulatory Strategy for Pharmaceuticals/Drugs in Taiwan
Taiwan is a sophisticated medical market where medical products are regulated fairly strictly. In some cases, U.S. or EU approvals can allow expedited registration.
Taiwanese medical regulations are continuously being revised. In particular, Taiwan's Department of Health (DOH) is making more use of independent agencies and assessment laboratories in the registration process. However, it is still possible to run into unexpected requirements for additional testing or clinical trials in Taiwan.
Additionally, in most cases, it is important for your medical product to receive reimbursement status so that it can be registered with Taiwan's National Health Insurance system.
PBM's regulatory experts can help your company determine the most cost-effective and time-efficient regulatory strategy for Taiwan.
For more information on regulatory issues 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
- Drug and Device Markets Throughout the Asian Region (PDF)
- Overview of Asia, Healthcare Markets and Regulatory Issues in the Region
- Taiwan: New Pharmaceutical Regulatory Trends
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