Medical Device Registration in Taiwan

Taiwan's medical device market is about $1.6 billion. It is one of the most advanced medical device markets in Asia.

The Department of Health (DOH) is Taiwan's equivalent of the U.S. FDA. All imported medical devices must obtain a registration certificate from the DOH's Bureau of Pharmaceutical Affairs (BPA). The DOH performs on-site inspection for local manufacturers and also reviews Quality System Documentation (QSD) provided by foreign manufacturers.

Medical device registration requires the submission of at least 6 different documents (some types of medical devices require additional documents). QSD requirements must be met before any product can be registered. QSD requirements are different for U.S. and non-U.S. factories.

Taiwan is one country where a foreign manufacturer can register their medical device (in their own name) through an independent third party if they do not have their own local office. PBM can also provide this service.

PBM can act as an In-Country Caretaker (ICC) and register the foreign medical device company's products in their own name.

For more information on medical device registration in Taiwan, please see the following PBM publications and/or contact us to discuss your specific needs.

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