ABSTRACT

The regulation of medical devices in Taiwan dates back to 1970, when the Pharmaceutical Affairs Act was promulgated. Enforcement rules of the act were subsequently enacted in 1973. To assure the quality and safety of medical products and to promote industry development, the Taiwan government has strived to reform and renovate the organization of the Department of Health (DOH). The Division of Medical Devices and Cosmetics in the Taiwan Food and Drug Administration (TFDA) handles the administration of medical devices in the public life cycle. The TFDA issues product licenses only to domestic firms and all foreign companies must make submissions through authorized domestic distributors or subsidiaries. The quality system of medical device manufacturers is audited to the requirements of Good Manufacturing Practice (GMP) using conformity assessment standard based on ISO 13485. Newly established manufacturers and new applications for device registration must comply with GMP beginning on February 10, 1999.