Taiwan Food and Drug Administration (TFDA) - Medical Device Regulation

The Taiwan Food and Drug Administration (TFDA), established under the Ministry of Health and Welfare (MOHW), is the central authority responsible for the management of medical devices in Taiwan. Its mission is to ensure the safety, efficacy, and quality of medical products through a comprehensive regulatory framework.

1. Regulatory Framework

The primary legal basis is the Medical Devices Act (independent from the Pharmaceutical Affairs Act since 2021). This act covers the entire lifecycle of medical devices, from design and clinical trials to manufacturing and post-market surveillance.

2. Classification of Medical Devices

Taiwan follows a risk-based classification system similar to international standards (IMDRF/GHTF):

• Class I (Low Risk): General bandages, tongue depressors.
• Class II (Moderate Risk): Blood pressure monitors, contact lenses.
• Class III (High Risk): Cardiac pacemakers, orthopedic implants.

3. Core Roles and Responsibilities

• Product Registration: Reviewing applications for medical device marketing authorization.
• Quality Management System (QMS): Enforcing compliance with ISO 13485 and Good Manufacturing Practices (GMP). Domestic and foreign manufacturers must obtain QMS certification to sell in Taiwan.
• Clinical Trial Oversight: Approving and monitoring clinical trials conducted within Taiwan.
• Post-Market Surveillance: Managing the reporting of adverse events, product recalls, and safety communications.
• International Cooperation: Participating in APEC workshops and the Global Harmonization Working Party (GHWP) to align Taiwan's standards with global practices.