Independent Third Party for Medical Devices and Pharmaceuticals/Drugs in Taiwan
In Taiwan, the holder (agent) of a medical product registration must be a Taiwan-based entity called the Independent Third Party. Medical companies without their own local Taiwan operations and who do not want to use their distributor as their agent can have an Independent Third Party in Taiwan maintain their product registrations in the name of the foreign manufacturer.
An Independent Third Party in Taiwan is responsible for applying to Taiwan's Department of Health (DOH) for product approval; reporting adverse events; and coordinating recalls.
PBM can act as your Independent Third Party in Taiwan.
For more information on the Independent Third Party system and medical regulations 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
- 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


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