MEDICAL DEVICE REGULATION IN TAIWAN

Medical devices are is regulated by the Taiwan Food and Drug Administration (TFDA) from the Ministry of Health and Welfare (MOHW) in Taiwan whose objective is to safeguard the national health and lead the nation to a new era of medical device management. Medical devices are regulated under the Pharmaceutical Affairs Act.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN TAIWAN

Medical devices are classified into 3 categories namely class I, II, and III (I being the lowest risk and III being the highest risk).

Devices which are made and approved in US or EU would go under an easier registration route.

The classification in Taiwan was referenced from US FDA classification, hence there is a similarity between having 3 classes in Taiwan.

• Class I requires simple registration with TFDA.

• Class II and III registration with TFDA must be submitted with the dossier containing elements in STED (Summary Technical Documentation), in addition to other administrative legalization documents.

The registration process with TFDA requires good communication as the evaluation is quite in depth in Taiwan.

The ARQon team also experiences a product approval process from consumer products to the professional-use of medical devices in Class II and III.

ARQon also assists manufacturers in the QSD application with the customization for the TFDA quality system requirements procedure into the manufacturer's Quality Management System (QMS).