🇹🇼Taiwan Medical Device Regulations

Medical Device Guidance, Law & Regulations Collection

Collection of medical device laws, regulations, and guidance documents from TFDA. Includes enforcement rules, classification rules, and compliance requirements.

Registration of Medical Devices

Medical device registration requirements including Class I, II, III, and PMA devices. TFDA issues medical device permit license upon approval.

TFDA Medical Device Premarket E-Submission System

Online premarket application platform launched January 21, 2022. Provides electronic submission for medical device applications, improving convenience and supporting paperless processing.

Medical Devices Act 2021 - Full Legal Text

Full legal text of Medical Devices Act from Laws & Regulations Database of Taiwan. Effective May 1, 2021. Establishes independent lifecycle management system for medical devices.

Taiwan Food and Drug Administration - Medical Devices

TFDA under the Ministry of Health and Welfare (MOHW) regulates medical devices in Taiwan. Manages device registration, QSD certification, and post-market surveillance.

Quality System Documentation (QSD) Application for Foreign Manufacturers

Official TFDA QSD application page for foreign manufacturers. QSD certification required for Class I Measuring/Sterile, Class II, and III devices. Certificate valid for 3 years.

Application for the Classification of Medical Devices

TFDA classification application page. Taiwan uses risk-based classification: Class I (low risk), Class II (moderate risk), Class III (high risk). Registration valid for 5 years.