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Taiwan Medical Device Registration

Taiwan Food and Drug Administration (TFDA) approval timelines and requirements

3-7 months
Typical Timeline
3
Device Classes
No
MDSAP Accepted
Required
Taiwan Agent

Taiwan Medical Device Registration Overview

Taiwan medical device registration through TFDA typically takes 3-7 months for Class I devices. The official TFDA target is 1-3 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Taiwan uses a 3-class (I, II, III) risk-based classification system. Foreign manufacturers must appoint a Taiwan Agent to register devices in Taiwan. Registration is valid for 5 years.

Registration Timeline by Device Class

Taiwan uses a 3-class (I, II, III) risk-based classification system.

Class I

Registration

Low Risk
Official
1-3 months
Realistic
3-7 months

• Varies by device type

Class II

Registration

Medium Risk
Official
6-10 months
Realistic
9-14 months
With Prior Approval
6-9 months

Accelerated with: FDA 510(k), EU CE Mark, Japan PMDA

• FDA or EU fast-track available

Local Testing RequiredGMP/QMS Required

Class III

Registration with clinical data

Highest Risk
Official
8-12 months
Realistic
1-1.5 years
With Prior Approval
8-11 months

Accelerated with: FDA 510(k)/PMA, EU CE Mark, Japan PMDA

• Clinical data required

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required
Expedited Pathways

QSD Abbreviated Pathway

Abbreviated QMS review for USA/EU/Japan manufacturers

2-3 months faster
Eligibility: USA, EU, or Japan manufacturer
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Taiwan registration.

FDA 510(k)
Fast-track pathway
2-4 months
EU CE Mark
Fast-track pathway
2-4 months
Japan PMDA
Fast-track pathway
2-4 months
Key Requirements
  • Taiwan Agent (for foreign manufacturers)
  • Traditional Chinese labeling
  • Local testing from accredited labs
  • QSD (Quality System Documentation)
Registration Validity:

5 years

Registration Process Flowchart

Taiwan Medical Device Registration Process

Step-by-step TFDA registration process. Total estimated timeline: 3-7 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by TFDA. Appoint a Taiwan Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to TFDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

TFDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-3 months

In-depth technical assessment of device safety and performance. TFDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, TFDA issues Taiwan market authorization certificate.

Summary: The Taiwan medical device registration process through Taiwan Food and Drug Administration (TFDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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Related Resources
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Compare With
🇺🇸 United StatesFDA🇪🇺 European UnionEU MDR🇨🇳 ChinaNMPA🇯🇵 JapanPMDA🇧🇷 BrazilANVISA🇨🇦 CanadaHealth Canada
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.