Taiwan
Taiwan is a growing market for medical devices, characterized by strong investments in advanced diagnostic technologies and personalized medicine solutions. The sector is supported by a well-developed industrial ecosystem, government incentives for innovation, and increasing demand for devices aimed at improving quality of life.
Regulatory Framework
The Taiwan Food and Drug Administration (TFDA) is the competent authority for medical device regulation. As of May 1, 2021, the Medical Devices Act introduced a new regulatory framework that strengthened safety requirements and post-market surveillance procedures.
Device classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
Registration Process – Step by Step
| Phase | Estimated Time | Required Documentation |
| Preparation | 3–6 months | Free Sale Certificate, manufacturer authorization, technical documentation, required safety certifications |
| Submission | 2 months | Complete dossier in Chinese |
| Evaluation | 6–12 months | Potential requests for additional documents, possible inspections for Class III devices |
| Approval | 1 month | License valid for 5 years |
Non-sterile Class I devices follow a simplified process, while Class II and III devices must meet more stringent requirements, including additional audits and specific certifications for regulatory compliance.
Specific Local Requirements
| Language | Documentation and labelling must be in Traditional Chinese. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certification | Free Sale Certificate, GMP/QSD certification required for sterile Class I, and all Class II and III devices. |
| License Validity | 5 years with renewal obligation. |
Challenges and Operational Advice
- GMP Compliance: Ensure that manufacturing processes meet TFDA standards.
- Accurate Translations: Make sure all documentation is precisely translated into Traditional Chinese.
- Realistic Timelines: The full approval process may take up to 18 months for complex devices.
- Regulatory Updates: TFDA has introduced new requirements for electronic devices and is actively monitoring international regulations regarding artificial intelligence in healthcare, although specific regulations for AI and machine learning have not yet been implemented.
Why Choose ISEMED
- Taiwan Market Expertise
Deep knowledge of local regulatory requirements. - Comprehensive Support
Assistance from documentation preparation to direct communication with TFDA. - Network of Contacts
Ongoing updates on regulatory changes and collaboration with local experts.
FAQ
- Is a local representative required? Yes.
- Documentation language? Traditional Chinese.
- License duration? 5 years, renewable.
- Are there new requirements for AI-powered devices? No, but TFDA is monitoring international regulations for possible future implementation.