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Taiwan Medical Device Distributor Guide

Taiwan’s Medical Devices Act (醫療器材管理法) and TFDA’s “醫療器材商管理制度” establish a clear regulatory framework for foreign manufacturers entering the Taiwan market. Distributors are not just commercial partners — they are regulated entities with defined compliance responsibilities, especially under GDP (Good Distribution Practice).

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1. Taiwan GDP (Good Distribution Practice)

 

1.1 What GDP Means in Taiwan

Taiwan GDP requirements ensure that medical devices are:

  • Stored properly

  • Transported safely

  • Distributed with full traceability

  • Managed by qualified personnel

  • Handled in a way that preserves safety and performance

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GDP is embedded in the Medical Devices Act and TFDA’s “醫療器材商管理制度,” which require distributors to maintain:

  • Adequate storage facilities

  • Environmental controls

  • Inventory and traceability records

  • Procedures for handling complaints, returns, and recalls

  • Proper documentation and record retention

 

1.2 Who Must Comply with GDP?

All medical device distributors (醫療器材販賣業者), including:

  • Importers

  • Wholesalers

  • Retailers

  • Exporters

  • Rental companies

  • Maintenance/service providers

GDP applies to all classes of medical devices.

 

2. Obligations & Qualifications of a Taiwan Distributor

 

Based on the Medical Devices Act (Articles 9–15), TFDA guidance, and your attached “醫療器材商管理制度” document.

 

2.1 Legal Definition

A distributor is any entity engaged in:

  • 批發 (wholesale)

  • 零售 (retail)

  • 輸入/輸出 (import/export)

  • 租賃 (rental)

  • 維修 (maintenance/service)

(Article 11)

 

2.2 Registration & Licensing Requirements

A distributor must obtain a Medical Device Distributor License from the local health authority.

Required items include:

  • Company registration

  • Warehouse address & layout

  • Storage facility documentation

  • Technical personnel (for importers or maintenance providers)

  • Business scope covering medical device distribution

  • Compliance with TFDA inspection requirements

(Per TFDA attachment, Article 9)

 

2.3 Key Obligations Under GDP

A. Storage & Environmental Control

  • Maintain proper temperature, humidity, and cleanliness

  • Prevent contamination, deterioration, or damage

  • Implement pest control and security measures

B. Inventory & Traceability

  • Maintain complete distribution records

  • Ensure traceability from manufacturer → importer → distributor → customer

  • Keep records for the required retention period

C. Transportation

  • Protect devices from shock, vibration, moisture, and temperature extremes

  • Use appropriate packaging and handling procedures

D. Complaint Handling & Recalls

  • Maintain complaint files

  • Report adverse events to TFDA

  • Execute recalls according to TFDA recall regulations

E. Technical Personnel Requirement

Importers and maintenance providers must employ qualified technical personnel (Article 15).

F. Cooperation with TFDA

  • Provide documentation during inspections

  • Assist in sampling, testing, and investigations

  • Ensure compliance with advertising and promotion rules

 

3. What We Can Offer (Three Service Models)

Your service structure aligns with Taiwan’s regulatory framework and mirrors the “Chinese Agent” model used in China.

 

A. Model 1 — Distributor Only 

Scope

  • Acts solely as importer/distributor

  • Does not serve as legal representative

  • Handles GDP compliance only

Manufacturer Responsibilities

  • Appoints a separate legal representative

  • Manages product registration

  • Handles post‑market obligations

Advantages

  • Distributor focuses on sales

  • Manufacturer retains regulatory control

  • Easy to switch distributors

 

B. Model 2 — Legal Representative

The legal representative is the entity authorized to:

  • Submit product registration

  • Communicate with TFDA

  • Handle adverse event reporting

  • Manage recalls

  • Maintain regulatory documentation

  • Ensure GDP compliance for imported devices

 

Key Requirement

The manufacturer must issue a formal authorization letter for each product or distribution arrangement.

Advantages

  • Streamlined TFDA communication

  • Distributor manages both regulatory and commercial activities

  • Faster response to post‑market issues

Limitations

  • Manufacturer becomes dependent on the distributor

  • Changing distributors requires license transfer

  • Potential conflict of interest

 

C. Model 3 — Outsourced Legal Representative in the Name of the Distributor

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How It Works

  • The distributor remains the official legal representative on TFDA records

  • All regulatory work is outsourced to your company

  • You operate under the distributor’s name, but with full technical and regulatory responsibility delegated to you

 

Legal Basis

Taiwan law allows outsourcing of regulatory tasks as long as:

  • The legal representative remains responsible to TFDA

  • The manufacturer provides proper authorization

  • The outsourced party follows TFDA requirements

Advantages

  • Distributor focuses on sales

  • Manufacturer benefits from professional regulatory support

  • No distributor lock‑in

  • Ensures high‑quality compliance (GDP, registration, PMS)

Ideal For

  • Manufacturers wanting independence

  • Distributors lacking regulatory expertise

  • Companies wanting professional compliance management

 

We can act as the outsourced legal representative or marketing authorisation holder in all critical markets, ensuring manufacturers maintain full regulatory control while distributors focus solely on commercial activities.

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