Medical Devices Regulatory Services
in Taiwan

Overview

Taiwan has a growing demand for Medical Devices. The Taiwan Food & Drug Administration (TFDA) under Ministry of Health and Welfare (MOHW) regulates Medical Devices through Pharmaceutical Affairs Act (PAA).

Regulatory Authority: Taiwan Food and Drug Administration

Regulation: Pharmaceutical Affairs Act (PAA) & Regulation for registration of Medical Devices

Authorized Representative: Taiwan Agent required

QMS Requirement: Quality System Documentation (QSD) ISO 13485

Assessment of Technical Data: Division of Medical Devices & Cosmetics

Validity of License: QSD - 3 Years; Product Registration - 5 Years

Labeling Requirements: Article 75, Pharmaceutical Affairs Act

Submission Format:  Paper

Language: English & Chinese

Taiwan Medical Device Classification

The TFDA classifies Medical Devices into 3 classes based on risk; Class-I for low-risk, Class II for moderate-risk and Class III for high-risk devices. The need for a predicate device poses challenge for novel devices to enter the market. Increased procedural time gap for Class II and III devices needing Quality System Documentation is another complexity involved. All imported Medical Devices must obtain a registration certificate from the TFDA

Device Class

Risk

Class I

Low Risk

Class II

Moderate Risk

Class III

High Risk

Taiwan Agent

Foreign manufacturers with no physical office in Taiwan should appoint a Taiwan Agent as a pre-requisite to market devices in Taiwan. Appointing a third-party organization as Taiwan Agent instead of distributor gives flexibility to explore multiple distributors for better market penetration.

Taiwan Medical Device Registration

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.

Process flow

Post Approval Medical Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between the TFDA and the manufacturer
  • Importation Management

Freyr specializes in catering to Regulatory needs of Medical Devices in Taiwan. With extensive network, Freyr helps in appointing a reliable local agent whose presence is of utmost importance throughout the post-marketing surveillance. Our experts also assist in selection of suitable predicate device and existing approvals from other markets to support new device market entry.

Summary

Device Class

Risk / Classification Criteria

QMS

Product Registration

Class I

Low Risk

Exempted

Yes

Class II

Moderate Risk

QSD

Yes

Class III

High Risk

QSD

Yes

Expertise

Freyr Expertise

  • Regulatory Due-Diligence 
  • Official Classification 
  • QSD Approvals
  • Device Registration 
  • Legal Representative 
  • Labeling support 
  • Translation support
  • Distributor identification and qualification 
  • Post Marketing Surveillance 
  • Post Approval Change Management
  • License renewal and transfer 
  • Submission and liaising