Medical Device Registration in Taiwan

• The Ministry of Health and Welfare (MOHW) performs on-site inspection for local manufacturers and also reviews Quality System Documentation (QSD) provided by foreign manufacturers.
• Under the MOHW, the Taiwan Food and Drug Administration (TFDA) is Taiwan’s equivalent of the U.S. FDA. All imported medical devices must obtain a registration certificate from the TFDA.

Yes, medical devices do require registration before being sold in Taiwan.

• Class I Device: Low Risk
• Class II Device: Moderate Risk
• Class III Device: High Risk
• PMA: New Medical Device (Medical devices for which there are no predicate devices approved by the TFDA. In other words, if there are no similar devices previously approved by the TFDA, your device will be considered a PMA device in Taiwan. This is the case even if your product has a Substantially Equivalent (SE) device approved by the U.S. FDA.

Before a medical device can be sold in Taiwan, Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration. QSD registration is only waived for Class I (non-sterile) medical devices. A QSD license (received upon QSD registration approval) in Taiwan, is similar to Good Manufacturing Practice (GMP) for medical devices.

Product Registration Process

Before importation and sale of a medical device (Class I, II, III, or PMA) in Taiwan, the device needs to be registered and approved by the TFDA.  The TFDA issues a “medical device permit license” upon product registration approval.

• Class I
  • Class I medical devices without brand names (e.g. surgical instruments or power accessories) usually follow a simple self-declaration process in Taiwan.
  • Timeline: The Class I registration approval process takes about 3 months.
• Class II and III
  • The figure below outlines the product registration approval process for Class II and II medical devices:

• PMA Medical Devices
  • The figure below illustrates the product registration approval process for PMA medical devices:

Class I Non-Sterile Medical Devices

• Simple declaration form
• Documents Required for QSD Registration
  • Documents required for Standard Mode:
    1. Quality Manual
    2. Quality Procedures per sub-clauses of ISO 13485
    3. Manufacturing Flow Chart
    4. List of major equipment
    5. Plant layout
    6. QSD Statement
    7. NB Statement to confirm the scope claimed
  • Documents required for Simplified Mode (for U.S.):
    1. Latest FDA EIR
    2. Certificate to Foreign Government (CFG)
    3. ISO 13485 Certificate
    4. QSD Statement
    5. NB Statement to confirm the scope claimed
  • Documents required for Simplified Mode (for EU):
    1. A test audit report (NB = TCP member)
    2. Free Sales Certificate
    3. QSD Statement
    4. NB statement to confirm the scope
  • Please note: for a non-sterile Class I medical device, no QSD registration is needed– only product registration is required.

Class II & III Medical Devices

Since July 2013, Taiwan requires the Summary Technical Documentation (STED) format for submissions of technical documents for all Class II and III medical devices.

• QSD registration certificate
• CFG with product codes and description
• Letter of authorization
• Labeling (Brochure, IFU, label of each product group)
• Product property
• Pre-clinical test reports
  • For Class II medical devices, pre-clinical test reports can be waived when both U.S. CFG and EU free sale certificate are available.

PMA Medical Devices

• QSD registration certificate
• CFG with product codes and description
• Letter of authorization
• Labeling (Brochure, IFU, Label of each product group)
• Product property
• Pre-clinical test reports
• Clinical safety reports

Foreign clinical data from Western countries are generally accepted; however, in certain cases (especially for PMA devices), the TFDA may request local testing.

Clinical data is required for all PMA devices and Class III IVD and DOH designated medical devices. Foreign clinical data from Western countries are generally acceptable.

Yes, approval for the medical device in the Country of Origin is required for registration.