Taiwan: Medical Device Regulatory System Introduction

Abstract

The population of Taiwan is about 23 million. Its medical device industry consists of approximately 1,157 firms and 46,953 workers. 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. Regulatory changes in the premarket approval process and post-market surveillance have continued to take place over the years in order to safeguard public health and harmonize with international regulations. The Division of Medical Devices and Cosmetics in the Taiwan Food and Drug Administration (TFDA) handles the administration of regulations concerning medical devices. All medical devices are required to be registered by TFDA before they can be manufactured domestically or imported from abroad. The TFDA issues product licenses only to domestic firms, and all foreign companies must make submissions through authorized domestic distributors or subsidiaries.