Taiwan medical device registration timeline

Source-linked clocks

Taiwan Food and Drug Administration (TFDA) review clocks and end-to-end planning ranges, using the 3-class (I, II, III) classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-29fda.gov.tw

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Registration) Statutory handling period 80 calendar days (initial review 47 + post-supplement review 33) for the non-counter filing route	80 days	3-7 months	—	Verified
Class II(Registration) Statutory handling period 140 calendar days (initial review 75 + post-supplement review 65)	140 days	9-14 months	6-9 months	Verified
Class III(Registration with clinical data) Statutory handling period 200 calendar days (initial review 105 + post-supplement review 95)	200 days	1-1.5 years	8-11 months	Verified
No-predicate device(Registration of a device with no similar marketed product) Statutory handling period 220 calendar days (initial review 80 + post-supplement review 40 + advisory-committee review 100), covering in-vitro diagnostic medical devices as well	220 days	1-2 years	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

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

80 days

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.

Expedited pathways

QSD Abbreviated Pathway2-3 months faster

Abbreviated QMS review for USA/EU/Japan manufacturers

Eligibility: USA, EU, or Japan manufacturer

Prior approval recognition

FDA 510(k)Fast-track pathway2-4 months

EU CE MarkFast-track pathway2-4 months

Japan PMDAFast-track pathway2-4 months

Key requirements

Taiwan Agent (for foreign manufacturers)
Traditional Chinese labeling
Local testing from accredited labs
QSD (Quality System Documentation)
Post-approval change clocks (TFDA handling-period table, 2026-08-17): plant address/spec/model 90 days; name/IFU/packaging 60 days; new spec/model/efficacy 180 days; manufacturing-licence-number change 30 days; licence extension 60 days (180 days where safety-monitoring or post-market study reports are required); transfer 60 days; clinical trial application 90 days

Primary regulator sources

fda.gov.tw · TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days

Reviewed 2026-08-29. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against TFDA publications · full review 2026-08-29 · row IDs are stable — cite as registration-timeline:taiwan:class-i