Regulatory Strategy for Medical Devices in Taiwan

Taiwan's medical device market is about $1.6 billion. To be successful in Taiwan, an excellent regulatory strategy is needed.

Product registration for medical devices for medical devices in Taiwan has become more complicated. Medical instruments are regulated by the Bureau of Pharmaceutical Affairs while Class II and III medical device registration review is regulated by the Bureau of Food & Drug Analysis (BFDA). The Center for Drug Evaluation (CDE) reviews clinical trial protocols and inspects trials.

For medical device registration in Taiwan, applicants submit a product registration application and also quality system documentation (QSD) depending on the classification and type of product. All Class II, III devices and Class I devices that are sterile or have metrological functions require QSD submission. The QSD includes information like plant layout plan, number of employees, free sales certificate, etc. Product registration documents include non-clinical test reports, clinical study report, final quality control records, technical documents, etc.

For more information on medical device regulatory issues 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