Taiwan Food and Drug Administration (TFDA)

The Taiwan Food and Drug Administration (TFDA) is the authority responsible for medical devices, drugs, food, and cosmetics in Taiwan under the Ministry of Health and Welfare. For medical devices, TFDA administers classification, product authorization, quality-system controls, labeling, and post-market oversight under the Medical Devices Act. Manufacturers entering Taiwan should use the acronym TFDA rather than the ambiguous phrase “FDA Taiwan.”

What does TFDA do for medical devices?

TFDA reviews or lists medical devices for market entry, registers medical device firms, oversees quality-management compliance, publishes technical requirements and databases, and manages vigilance, recalls, and enforcement. Some review or audit activities may involve designated organizations, but TFDA remains the national regulator.

How are medical devices classified in Taiwan?

Taiwan uses Class 1, Class 2, and Class 3, from lower to higher risk. Classification and the applicable product category determine whether listing or pre-market registration is required and what technical evidence must be filed. Manufacturers should confirm the exact classification item and product code because similar-looking products can follow different controls based on intended use.

What is the TFDA registration pathway?

Qualifying low-risk Class 1 products may use a listing route, while Class 2 and Class 3 products generally require registration and a medical device license. A dossier can include administrative forms, device description and specifications, quality-system evidence, labeling and instructions, testing, risk management, and clinical or performance evidence. The review scope depends on the product and pathway.

Does a foreign manufacturer need a Taiwan agent?

An overseas manufacturer generally works through a locally established medical device firm that acts as the license holder and applicant. The local party supports submission, importation, authority correspondence, changes, vigilance, and recalls. The contract should clarify control of the license, access to technical documents, and how a future transfer will be managed.

What quality-system requirements apply?

Manufacturers must meet Taiwan's medical device quality-management requirements. The relevant quality-system registration or compliance process should be coordinated with product registration. Manufacturing-site names, addresses, device scope, and subcontracted activities must be consistent across the application and supporting certificates.

How can I verify TFDA requirements?

Use TFDA's medical device information hub and the official Medical Devices Act. TFDA lists +886-2-2787-8000 as its general telephone number.

Related Taiwan regulatory topics

See our Taiwan medical device registration overview for product licensing and local representation planning.