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

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:  5-6 months (Class I – Low Risk),  1 month (Class I – Low Risk, Listing System)
• 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:

Documents Required for Each Class

• QSD registration certificate(s)
• Manufacturer(s) letter(s) of authority – original hardcopy required

Class I Registration

• QSD registration certificate(s) (if applicable)
• Manufacturer(s) letter(s) of authority (if applicable) ) – original hardcopy required

Class II Registration

• QSD registration certificate(s)
• Manufacturer(s) letter(s) of authority (if applicable) – original hardcopy required

• IFU/Operation manual
• Photo/label/packaging/UDI info
• Letter of Authorization – TFDA template; original hardcopy required.
• CFG/Free Sales Certificate (FSC) – original hardcopy required; notarization by either Taiwan’s embassy or consulate, representative office, the official office stationed in the region, or an overseas organization authorized by the Ministry of Foreign Affairs is required
• Documents related to product structures, materials, specifications, functions, intended uses, and drawings
• Preclinical testing (safety and performance data) (containing the test specifications, methods, records, and test reports) – For instance:
  • Biocompatibility test
  • Electrical safety test
  • Electromagnetic compatibility test
  • Software validation test
  • Performance test
  • Human factors usability test
  • Sterilization validation
  • Physical and chemical properties
  • Mechanical and/or animal testing
  • Shelf life
• Final quality control (containing the test specifications, methods, records, and test reports)

Class III/NEW Registration

• Required items listed for Class II Registration (see above) +:

• EP (Essential Principles)
• STED (Safety and Performance of Medical Devices and Summary Technical Documentation)
• Clinical evidence information (academic and theoretical base, relevant research reports and data; clinical evaluation report, or clinical report) (if applicable)

Common Documents Required for Each QSD Application Mode

• ISO 13485 certificate
• Notified Body letter (This item may or may not be required depending on how clear the information on the ISO certificate is for the TFDA. We discuss this item in a case-by-case basis, after reviewing the ISO 13485 cert information.) – original hardcopy required
• QSD Statement (TFDA Template – basic information on the manufacturer) – original hardcopy required.
• Manufacturing Process Flow Chart (If there are any outsourcing steps, please indicate the name of the subcontractors beside the steps)
• MDF or DMR (Including the information about the indications for use, specification, manufacturing, packaging, storage, transport, distribution instruction, quality control instruction, installation instruction, service instruction)

Standard – for all manufacturers/Essential Mode – for manufacturers who produce certain designated product categories

• Required items listed in the common documents
• Plant layout (A floor plan of each building on the site labeled with its functions, including the location of main gates, storage areas, receiving and dispatch bays, manufacturing areas, packaging areas, testing areas, and offices, etc.)
• Manufacturing site layout (Including the personnel flow, operation flow, material flow, and finished product flow)
• List of the main equipment for production and inspection (The equipment name and quantity for manufacturing, assembly, packaging, sterilization, testing, etc. The manufacturing equipment and testing equipment must be listed separately.)
• SOP Index – original hardcopy required.
• Quality Manual
• All the SOPs per ISO 13485 sub-clause (essential mode requires fewer sub-clauses)

US Abbreviated Mode – for manufacturers who are located in the US

• Required items listed in the common documents
• CFG – original hardcopy required
• FDA EIR for the past 3 years/ MDSAP audit report within one year

TCP Abbreviated Mode (Technical Cooperation Program) – for manufacturers who are members of the EU

• Required items listed in the common documents
• FSC – original hardcopy required
• Audit report within one year

TFDA Government Fees (per application/approx. USD)

• Class I (Low Risk): $611/ Class I (Low Risk – Listing System): $370
• Class II (Medium Risk): $2,204
• Class III (High Risk): $3,759
• New (No predicate devices previously approved by the TFDA): $4,870
• QSD Registration: $2,222, $1,111 for some low-risk, non-sterile Class I
• Direct Import Authorization (DIA): $148

Note: The government fee will be adjusted depending on the TFDA’s announcements and the exchange rate.

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.