Taiwan TFDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Taiwan FDA (TFDA), under the Ministry of Health and Welfare
Key Legislation:
- Medical Devices Act (enacted 2021, replacing relevant sections of Pharmaceutical Affairs Act)
- Medical Devices Management Regulations
- Regulations for Registration of Medical Devices
Classification: Risk-based, 3 classes:
- Class I (low risk) | Class II (medium risk) | Class III (high risk)
- Further divided into tiers based on specific product categories
Registration Pathway:
- Class I: Listing notification (simplified)
- Class II/III: Full registration application with technical documentation
- Appoint a local authorized representative (for foreign manufacturers)
- Submit via TFDA online system with Chinese-language documentation
- GMP/QSD inspection may be required for manufacturing sites
Key Requirements:
- Medical Device License required before marketing
- Local authorized agent mandatory for foreign manufacturers
- QSD (Quality System Documentation) inspection for manufacturing facilities
- Chinese-language labeling and IFU required
- Clinical data may be required for Class III and novel devices
- License validity: 5 years, renewable
Current Key Guidance:
Latest Updates
No recent updates available. Please check back later.