Agency
All medical devices are regulated by the Taiwan Food and Drug Administration (TFDA) as part of Ministry of Health and Welfare (MOHW)
Medical Device Definition
The instruments, equipment, apparatus, accessories and spare parts which are used for diagnosing, curing, alleviating and directly preventing human diseases, or changing the structure and function of the human body
Classification of Medical Device *
International Classification |
Examples |
Risk Level |
Type of regulation |
Class I |
Stethoscope, breath-alcohol test system |
Low |
Quality System Documentation (QSD) registration, if not exempted, and notification to TFDA |
Class II |
Protein test systems, syringes |
Moderate |
QSD registration and product registration with TFDA or Certification with third party |
Class III |
External/internal pacemakers, plasma warming device |
High |
QSD registration and product registration with TFDA, clinical data required |
Notes
- Medical device registration certificate is valid for five years. Renewal must be submitted 6 months before expiration
- All documents can be written in English, except the IFU, which must be written in Chinese
- Current Status: Pharmaceutical Affairs Act (PAA)
* See appendix 1, 2 for details
Appendix 1Appendix 2
When Is Preclinical Testing and Clinical Trial Information Required?
- For Class I and II medical devices: if approved for sale in the US and Europe then a Simplified Application Route is available and preclinical testing review by the TFDA is not required
- Medical Devices with technology that is novel to Taiwan as well as High Risk Medical Devices require clinical trial information review by the TFDA
Is Local Clinical Testing Required for Registration?
- In some cases, especially for Novel Medical Devices, the TFDA may require local testing
Source: TFDA site