Taiwan Medical Devices Regulations

Regulatory compliance for the (country) market 

Taiwan Medical Devices Regulations

Taiwan’s Ministry of Health and Welfare (MOHW) is the government ministry responsible for the country’s healthcare regulations. The MOHW has a broad mandate to improve the quality of healthcare, prevent and control infectious diseases, ensure food and drug safety, and facilitate technological development. 

Within the MOHW, the Taiwan Food and Drug Administration (TFDA) is responsible for managing the regulatory system for the safety and quality of food, drugs, medical devices, and cosmetics. The TFDA drafts and implements regulations, grants product registration and clinical trial approvals, monitors manufacturing and importation, and conducts safety surveillance activities on health products. 

In May 2021, Taiwan announced a new Medical Devices Act, which changes the way medical device products are classified, groups products by risk and category, and adjusts registration fees. It also reinforces post-market surveillance of the safety and quality of devices by mandating regulations for product recalls. 

Regulatory Requirements in Taiwan

Labeling  
The label and IFU must be written in Chinese. 

Technical Personnel requirements 
The Medical Devices Act stipulates in Article 15 that manufacturers and importers of medical devices must appoint designated Technical Personnel, effective May 1, 2021. The Administrative Measures for Medical Device Technicians outlines the requirements and qualifications for medical device Technical Personnel required for all manufacturers and dealers. The new requirement will be subject to a three-year transition period. 

UDI requirements  
Taiwan has begun a phased implementation of UDI, which includes both labelling and database reporting requirements. The “Requirements for Indicating the Unique Device Identifier on Medical Device Labels" came into force on 1 May 2021. 
Issuing agencies include GS1, HIBCC and ICCBBA.