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Taiwan QSD for Imported Medical Devices 

1. What Is Taiwan QSD?

 

Taiwan’s Quality System Documentation (QSD) is the quality management approval required by the Taiwan Food and Drug Administration (TFDA) for manufacturers of imported medical devices. It demonstrates that the manufacturer’s quality system complies with Taiwan’s Medical Devices Act and the Medical Device Quality Management System Regulations.

QSD applies to Class I, II, and III medical devices, except for products listed on TFDA’s exemption list.

A QSD certificate is valid for three years, and manufacturers must renew it every three years to maintain market access.

 

2. Applicable Taiwan Regulations

 

Imported medical device manufacturers must comply with:

  • Medical Devices Act

  • Medical Device Quality Management System Regulations

  • TFDA guidance on QSD application, renewal, and change registration

These regulations define the scope, documentation, and obligations for foreign manufacturers.

 

3. Required Quality Management Documents

 

TFDA typically requires:

  • Quality manual

  • Organizational chart

  • Procedures for design, production, risk management, CAPA, supplier control

  • Device master file or product technical documentation

  • Post‑market surveillance procedures

  • Evidence of legal manufacturer identity and facility address

  • ISO 13485 certificate (if available)

  • Declaration of conformity to QMS requirements

Additional documents may be required depending on device class or manufacturing structure.

 

4. Timeline and Cost

 

TFDA’s review time for QSD applications is typically:

  • 6 to 12 months for imported medical devices (depending on completeness, device class, and TFDA questions)

Costs vary depending on:

  • Number of product categories

  • Whether the manufacturer uses a consultant

  • Translation and administrative fees

 

5. When Must a Taiwan QSD Be Changed?

 

A QSD change registration is required when significant changes occur at the manufacturing site. Common triggers include:

 

5.1 Relocation of the Manufacturer

  • Change of factory address

  • Consolidation or expansion of manufacturing sites

 

5.2 Change of Ownership

  • Acquisition

  • Merger

  • Legal entity change

 

5.3 Expansion of Product Scope

  • Adding new device categories

  • Adding new product families under the same QSD

 

5.4 Change of Management Representative

  • Appointment of a new person responsible for QMS compliance

 

5.5 Change of Domestic Medical Device Firm (Taiwan Agent)

  • Transfer of agent rights

  • Termination and re‑authorization of a new agent

 

6. Practical Tips for Manufacturers

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  • Ensure all documents are official, signed, and recent

  • Keep consistency between QSD, ISO 13485, and product registration files

  • Coordinate early with your Taiwan agent to avoid delays

  • Plan ahead: changes often require several months for TFDA review

 

7. Conclusion

 

QSD is a critical regulatory requirement for imported medical devices in Taiwan. Understanding when and how to update QSD ensures continuous compliance and avoids delays in product registration or market access. With proper preparation and documentation, manufacturers can navigate QSD change registration smoothly and maintain uninterrupted operations in the Taiwan market.

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Where else manuacturer needs additional registration of country specific quality management? see our overview.

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