Taiwan's Department of Health (DOH)

Taiwan's DOH regulates the safety and quality of cosmetics, medical devices, and pharmaceuticals. The DOH is divided into seven bureaus, with the Bureau of Pharmaceutical Affairs (BPA) and the Bureau of Food and Drug Analysis (BFDA) responsible for the regulation of pharmaceuticals and medical devices, respectively.

The BPA and BFDA jointly handle the New Drug Application review process. The BPA performs an initial review and safety surveillance, after which the BFDA conducts testing and process validation.

For medical devices imported into Taiwan, the DOH reviews the Quality Systems Documentation (QSD) of foreign manufacturers and conducts on-site audits and inspections of local manufacturers. The DOH requires that import applicants submit their Plant Master File before registering any specific drugs. In some cases, the DOH also requires local clinical trials and bridging studies.

The DOH works with the World Health Organization to ensure that drugs and devices on the Taiwanese market conform to international standards.

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