Taiwan’s Quality System Documentation (QSD) System: Requirements for U.S. Firms

Taiwan’s Quality System Documentation (QSD) system requires device manufacturers to pass a “paper audit” before medical devices can be registered in that country. QSD is part of Taiwan’s Good Manufacturing Practices (GMP) system, implemented for medical devices in early 1999. Under Taiwan’s GMP procedures, domestic device manufacturers are subject to site inspection, while importers must pass a QSD review. Registration dossiers for medical devices will be rejected outright if submitted prior to obtaining GMP/QSD approval.

In January 1998, Taiwan’s Department of Health (DOH) signed an agreement with the U.S. FDA, under which the FDA agreed to provide redacted copies of Establishment Inspection Reports (EIRs) in exchange for an exemption from the full requirements of QSD for U.S. manufacturers. U.S. firms were to be exempt from full QSD if they submitted an FDA EIR, Certificate to Foreign Government, and ISO 13485 Certificate. However, in reality, the DOH often requires full GMP submissions even from those who meet the above requirements. As of September 2000, 360 GMP applications had been submitted and 177 — 49 percent — were approved. Approved applications came from 24 domestic and 153 import factories.

Full details of the requirements for QSD can be obtained through Taiwan’s Bureau of Pharmaceutical Affairs, part of the DOH. The DOH website may be found at: http://www.doh.gov.tw/english/Welcome.html.