Taiwan FDA guidance medical device software
Taiwan Medical Device Regulations

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 ClassificationExamplesRisk LevelType of regulation
Class IStethoscope, breath-alcohol test systemLowQuality System Documentation (QSD) registration, if not exempted, and notification to TFDA
Class IIProtein test systems, syringesModerateQSD registration and product registration with TFDA or Certification with third party
Class IIIExternal/internal pacemakers, plasma warming deviceHighQSD registration and product registration with TFDA, clinical data required
Premarket Approval Process *
Class IClass IIClass III
Appoint Taiwan Agent to manage device registration.
Prepare QSD application including general information (such as user manual and manufacturing information), ISO 13485 certificate, and QSD certificate. Submit application for review. If approved, QSD approval letter will be issued, which is valid for three years.
Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG)
Prepare registration application and necessary documents including general product information, IFU, and QSD letter.Prepare registration application including IFU, general information, QSD letter, and product testing reports. Preclinical data may be required. Most testing conducted outside of Taiwan is accepted.
Novel medical devices are subject to TFDA Medical Device Committee Review and require clinical trial information.
TDFA will issue Medical Device Product License.
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?

  1. 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
  2. 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?

  1. In some cases, especially for Novel Medical Devices, the TFDA may require local testing

Source: TFDA site

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