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Taiwan medical device regulations

Official sources linked

TFDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

30 documents7 categories100% linked to official sourcesauthority TFDA24 readable HTML
CodeRegulationCategoryEffectiveProvenance
Medical Devices Act
Medical Devices Act
Controlling Chinese text from the Ministry of Justice Laws Database (pcode L0030106), with the authority English translation ingested separately. Promulgated 15 January 2020 (ROC 109-01-15); Executive Yuan set the effective date as 1 May 2021. 85 articles.
GeneralMay 1, 2021Official
醫療器材行政規費收費標準
Standards for Medical Device Administrative Fees
Authorized subordinate pcode L0030123, announced 23 February 2023. 4 articles. The Ministry of Justice English translation page returns empty bytes, so only the Chinese controlling text is ingested. Distinct from the shared food/drug/cosmetics laboratory-fee schedule L0040094, which was not ingested.
General—Official
Regulations Governing Border Inspection and Examination of Imported Medical Devices
Regulations Governing Border Inspection and Examination of Imported Medical Devices
Authorized subordinate pcode L0030122, last amended 31 March 2025. 19 articles. Chinese controlling text plus authority English translation.
Registration—Official
Classification System
Application for the Classification of Medical Devices
TFDA classification-application portal. The exact classification instrument is tw-classification-regulations (L0030120).
Classification—Official
L0030120 Annex
Medical Device Classification Items — Official Annex
Official English Annex to Article 4 of the classification regulations: 1,812 medical-device classification numbers with authority product name, Class 1–3, and identification text. The parent regulation remains tw-classification-regulations.
Classification—Official
Regulations Governing the Classification of Medical Devices
Regulations Governing the Classification of Medical Devices
Authorized subordinate regulation pcode L0030120. Chinese controlling text plus authority English translation. Distinct from the TFDA classification-application portal.
Classification—Official
Regulations Governing Contract Manufacturing of Medical Devices
Regulations Governing Contract Manufacturing of Medical Devices
Authorized subordinate pcode L0030117, announced 15 April 2021. 10 articles. Chinese controlling text plus authority English translation.
GMP/QMS—Official
E-Submission System
TFDA Medical Device Premarket E-Submission System
E-submission platform announcement, not a legal instrument. Not ingested.
Registration—Official
Enforcement Rules of the Medical Devices Act
Enforcement Rules of the Medical Devices Act
Authorized subordinate regulation pcode L0030121, announced 26 April 2021. Chinese controlling text plus authority English translation.
General—Official
Regulations Governing Commission of Medical Devices Management and Accreditation of Commissioned Institution
Regulations Governing Commission of Medical Device Management Matters
Authorized subordinate pcode L0030129, announced 29 April 2021. 23 articles. Chinese controlling text plus authority English translation.
General—Official
Regulations on Good Clinical Practice for Medical Devices
Regulations on Good Clinical Practice for Medical Devices
Authorized subordinate pcode L0030114, announced 9 April 2021. 72 articles. Chinese controlling text plus authority English translation.
Clinical Trials—Official
Regulations of Medical Device Good Distribution Practice
Regulations of Medical Device Good Distribution Practice
Authorized subordinate pcode L0030115, announced 13 April 2021. 30 articles. Chinese controlling text plus authority English translation.
GMP/QMS—Official
Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License
Regulations for GDP Inspection and Distribution Licence Issuance
Authorized subordinate pcode L0030111, announced 29 January 2021. 12 articles. Chinese controlling text plus authority English translation.
GMP/QMS—Official
Regulations Governing Incentive Rewards for Research and Development of Innovative Medical Devices Technology
Regulations Governing Incentive Rewards for Innovative Medical Device R&D
Authorized subordinate pcode L0030130, announced 29 April 2021. 8 articles. Chinese controlling text plus authority English translation.
General—Official
Regulations Governing Designation or Commission of Medical Devices Test
Regulations Governing Designation or Commission of Medical Devices Test
Authorized subordinate pcode L0030131, announced 30 April 2021. 9 articles. Chinese controlling text plus authority English translation.
General—Official
Regulations Governing Accreditation and Outsourced Accreditation Management of Medical Devices Institutions
Regulations Governing Accreditation of Medical Device Testing Institutions
Authorized subordinate pcode L0030127, announced 29 April 2021. 32 articles. Chinese controlling text plus authority English translation.
General—Official
TFDA Law & Regulations
Medical Device Guidance, Law & Regulations Collection
TFDA collection page. Exact subordinate instruments are identified on the Ministry of Justice authorized-subordinate list for L0030106, not on this portal.
General—Official
Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
Authorized subordinate pcode L0030128, last amended 27 November 2023. 27 numbered articles including official Article 13-1 in both Chinese and the authority English translation.
Registration—Official
醫療器材製造業者設置標準
Standards for Establishment of Medical Device Manufacturers
Authorized subordinate pcode L0030110, announced 10 December 2020. 10 articles. The Ministry of Justice English translation page returns empty bytes, so only the Chinese controlling text is ingested.
GMP/QMS—Official
Medical Device Quality Management System Regulations
Medical Device Quality Management System Regulations
Authorized subordinate pcode L0030116, announced 14 April 2021. 79 articles. Chinese controlling text plus authority English translation. Distinct from the TFDA QSD application portal.
GMP/QMS—Official
Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license
Regulations Governing QMS Inspection and Manufacturing Licence Issuance
Authorized subordinate pcode L0030112, announced 2 February 2021. 13 articles on QMS inspection and manufacturing-licence issuance. Chinese controlling text plus authority English translation.
GMP/QMS—Official
QSD Certification
Quality System Documentation (QSD) Application for Foreign Manufacturers
TFDA QSD application portal. The exact QMS subordinate instrument is tw-qms (MOJ pcode L0030116); the inspection/licence instrument is tw-qms-inspection (L0030112).
GMP/QMS—Official
Regulations for Medical Device Recalls
Regulations for Medical Device Recalls
Authorized subordinate pcode L0030126, announced 28 April 2021. 14 articles. Chinese controlling text plus authority English translation.
Vigilance—Official
Device Registration
Registration of Medical Devices
TFDA registration overview page, not the Medical Devices Act. Not ingested.
Registration—Official
Regulations for Management of Medical Device Safety Surveillance
Regulations for Management of Medical Device Safety Surveillance
Authorized subordinate pcode L0030125, announced 28 April 2021. 15 articles. Chinese controlling text plus authority English translation.
Vigilance—Official
Exports carry source + retrieval date

Changes after registration in Taiwan

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring prior approval

Fact-level verified

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval-required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Conditions
  • Applies to registration licences and filing items as designated; sample/testing rules apply to certain composition or site changes (Art. 13-1).

Confirms baseline change-outcomes fact with itemised official list.

  • Filing route and prior approval
  • Supporting documents

Self-managed minor changes

Fact-level verified

Minor label/packaging changes need no prior approval: (a) changes that do not alter the approved text (materials/graphics, proportional resizing, font changes, adding printed outer boxes), and (b) enumerated text changes such as adding or changing barcodes, recycling marks, CE marks, suggested retail prices, or distributor name/address; the holder makes the change and keeps a change record.

Conditions
  • Limited to the enumerated label/packaging changes in Art. 14.
Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring prior approval

Fact-level verified

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval-required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Conditions
  • Applies to registration licences and filing items as designated; sample/testing rules apply to certain composition or site changes (Art. 13-1).

Confirms baseline change-outcomes fact with itemised official list.

Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring prior approval

Fact-level verified

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval-required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Conditions
  • Applies to registration licences and filing items as designated; sample/testing rules apply to certain composition or site changes (Art. 13-1).

Confirms baseline change-outcomes fact with itemised official list.

Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring prior approval

Fact-level verified

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval-required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Conditions
  • Applies to registration licences and filing items as designated; sample/testing rules apply to certain composition or site changes (Art. 13-1).

Confirms baseline change-outcomes fact with itemised official list.

Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

Use this market context

Continue from regulations into practical research

Keep Taiwan as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for Taiwan

Check a preliminary TFDA risk class.

Search registered products

Inspect public TFDA records.

Compare products across markets

Search the same product in multiple country registries.

Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against Taiwan needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current TFDA update against one product and its evidence.

Keep researching this market

More Taiwan medical device resources

View the Taiwan resource hub →
Compare regulations across all countries →
Continue with this market
Tracked from official TFDA publications · row IDs are stable — cite as regulations:taiwan:tw-admin-fees