TFDA market access

Taiwan medical device registration resources

Research TFDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Taiwan medical device resource.

89,088 license records11 free resources24/25 topics with records30 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official TFDA device registration records.

Medical device registry insights

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Medical device regulations

Browse official TFDA regulations and guidance documents.

Government registration fees

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AI registration cost and timeline planner

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Medical device regulation news

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AI medical device classifier

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Additional certification and licence checker

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AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare TFDA statutory handling periods with realistic approval times by device class.

Structured regulatory requirements

Explore all 80 source-linked facts →

24 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Commissioned institutions conduct training and QMS/GDP inspections: The central authority may commission legal entities or associations to run technical personnel training and to conduct device firm inspections covering Act Art. 22 QMS matters and Act Art.…
Competent authority: Ministry of Health and Welfare (MOHW) is the competent authority at the central level for medical devices; municipal and county/city governments are the local competent authorities. The Min…

2 source-linked facts

Checked 2026-08-28

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D02

Legal basis & guidance

Verified

Primary legislation and effective date: Medical Device Act (醫療器材管理法), 85 articles, promulgated 2020 01 15 by Presidential Order 華總一義字第10900004021號; effective date 2021 05 01 fixed by Executive Yuan Order 行政院院臺衛字第1100001220號 (issu…
Transition from Pharmaceutical Act: From the Medical Device Act's effective date, device matters are governed by the Medical Device Act and the device provisions of the Pharmaceutical Act (藥事法) cease to apply.

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition: Medical device means instruments, apparatus, appliances, materials, software, in vitro diagnostic reagents and related articles whose design and use act on the human body by means other tha…
Software and IVDs inside the definition: Software (軟體) and in vitro diagnostic reagents (體外診斷試劑) are explicitly named within the statutory definition of medical device, so SaMD and IVDs fall under the same regime (no separate IVD…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through III.: Class I, Class II, Class III

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Class I filing process: Class I filing (登錄) is done in the central authority's online medical device filing system: the applicant enters product name, firm and manufacturer data, classification item code, sterilis…
Registration vs filing routes: Manufacture or import of a medical device requires registration (查驗登記) with the central authority and a medical device licence (醫療器材許可證); however, item categories announced by the central a…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

China NMPA approval: origin evidence only: statement: TFDA import registration for Class II/III devices requires an original 出產國許可製售證明 (certificate that the device is approved for manufacture and free sale) issued by the highest hea…
China-made devices: MOEA import permission required before TFDA registration: statement: Taiwan does not recognise NMPA approval and additionally restricts PRC origin devices: 附表二說明十三(三) provides that a device manufactured in China may only be submitted for TFDA reg…

4 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Contract manufacturing approval, registration and liability: Contract manufacturing means entrusting the full process (manufacture, packaging, labelling, sterilisation and final release) or the manufacturing/sterilisation steps to another device manu…
Outsourced distribution activities need written contracts: Where a distributor outsources import, storage, transport, sale, protection or servicing to another party, the arrangement must be covered by a written contract and monitored wherever it ca…

5 source-linked facts

Checked 2026-08-28

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D08

Establishment, import & distribution

Verified

Medical device business permit: To operate as a medical device firm (manufacturer or distributor, including importers), the company must be approved and registered with the municipal or county/city government health autho…
GDP system and distribution permit: Distributors of announced device categories must establish a good distribution practice (優良運銷) system per the GDP Regulations and pass central authority inspection to obtain a distribution…

11 source-linked facts

Checked 2026-08-28

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D09

Dossier requirements

Verified

Class I registration dossier: Class I registration applications must include the documents and data of Annex 1 (documents for Class I device registration for manufacture or import); the central authority may decline to…
Class II/III registration dossier: Class II and III registration applications must include the documents and data of Annexes 2 and 3, which include (per the regulation's definitions and extension article) the country of orig…

4 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official submission systems: Official channels: the medical device registration electronic submission system (醫療器材查驗登記電子化送件系統, https://mds.fda.gov.tw/) for Class I (non filing) registration, Class II/III registration,…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Chinese label and IFU: Devices may only be sold, wholesaled or retailed with a Chinese label on the smallest sales package and an accompanying Chinese instruction for use (except where announced or approved other…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Sterilisation and packaging equipment requirements: Manufacturers performing sterilisation must be equipped with sterilisation equipment and sterility testing equipment (the latter excused where sterility testing is not performed). Packaging…
Unannounced GDP inspections: The central authority may conduct unannounced inspections of distributor premises at any time without prior notice. Municipal/county authorities may be invited to join. Inspectors must show…

7 source-linked facts

Checked 2026-08-28

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D13

Standards, testing & ancillary approvals

Unresolved

TFDA electrical/EMC evidence: Electrical safety
NCC Type Approval/DoC/simplified DoC: Wireless / radio
BSMI inspection/certification: Adapters / components

4 maintained overlays · 3 related facts

Checked 2026-08-28

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D14

Fees

Verified

Class I device registration (查驗登記): TWD 15,000
Class II device registration (查驗登記): TWD 58,000

24 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class I · Registration: 80 days
Class II · Registration: 140 days
Class III · Registration with clinical data: 200 days

4 maintained pathways · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Class I annual declaration: Class I filers whose filing has been complete for one year must perform an annual declaration (年度申報) each October in the filing system, confirming the filed particulars and paying the annua…
Licence duration: The manufacture/import licence is valid for a maximum of five years from the issuance date. To continue, an extension must be approved before expiry; each extension may not exceed five year…

5 source-linked facts

Checked 2026-08-28

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Lifecycle & post-market

D17

Change control

Verified

Changes requiring prior approval: 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 pro…
Self-managed minor changes: 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),…

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Single identification and implantable traceability in manufacture: Manufacturers must operate a written product identification and traceability procedure. For device categories announced by risk level under Act Art. 19(1), a written single identification s…
GDP traceability record contents: Distributors must operate a written traceability procedure for product source and flow. The records must carry the device name, batch number, receipt date and quantity, shelf life, supplier…

5 source-linked facts

Checked 2026-08-28

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D19

Clinical investigation & performance

Verified

Sponsor GCP obligations: Sponsors must define, execute and manage the clinical trial and ensure data integrity and subject rights, safety and welfare (GCP Regulations Art. 5; investigator initiated trials are subje…
Clinical trial approval requirement: Sponsors or trial institutions must obtain central authority approval before starting a medical device clinical trial; announced non significant risk device trials are exempt from prior app…

3 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Personal-use import limits: Personal use import (無需醫師或專業人員操作、由自然人自行使用之醫療器材) is limited: consumables to a six month supply, instruments to one unit per model; expedited clearance for listed items and quantities is limi…
Project approval applicant eligibility per ground: Each project approval ground under Act Art. 35(1) has defined eligible applicants: (1) prevention/diagnosis/treatment of life threatening or seriously disabling disease — regional teaching…

4 source-linked facts

Checked 2026-08-28

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D21

Manufacturer PMS

Verified

Monitoring period and report frequency: The safety monitoring period runs three years from the licence issuance, filing, announcement or designation date (extendable where necessary). Periodic reports are due semi annually: the d…
Safety monitoring duty: For devices approved or filed, the central authority may order the device firm to conduct safety monitoring under an approved monitoring plan; firms must prepare periodic safety monitoring…

3 source-linked facts

Checked 2026-08-28

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D22

Vigilance & incident reporting

Verified

Licence holder deadline: The licence holder or filer must complete the report within 15 days of discovering the event, then proactively investigate and evaluate corrective and preventive measures (reporting records…
Medical care institution deadlines and channel: Medical care institutions report within 7 days of discovery for death or life threatening events and within 15 days for other serious events. Reporting is done via the central authority's d…

3 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Disposal of recalled devices and trading stop: From the announcement, legal determination or permit revocation date, medical care institutions and device firms must stop importing, manufacturing, wholesaling, retailing or displaying the…
Distributor recall and reporting procedures with annual effectiveness review: Distributors must maintain operating procedures for serious adverse event reporting (Act Art. 48(1)), Act Art. 49 notifications, corrective and preventive measures, and Act Art. 58 recall n…

5 source-linked facts

Checked 2026-08-28

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D24

Advertising, claims & promotion

Verified

Advertising prior approval: Before publishing medical device advertising, the licence holder or filer must apply to the municipal or central authority with the advertising content for approval; after approval the hold…
Professional-audience restriction and prohibited practices: Devices whose IFU states they must be used by healthcare professionals (and announced devices) may only be advertised in media aimed exclusively at healthcare professionals or at profession…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Objection and appeal against fines: Against administrative fine decisions, the party may submit a written objection and request review within 15 days of delivery of the decision notice (once only); if unresolved, administrati…
Reconsideration of registration decisions: Applicants whose registration, filing or clinical trial applications are not approved may file one reconsideration request (申復) within four months of delivery of the decision, on procedural…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (24 lines) →

TFDA registration fees in TWD · reviewed 2026-08-25

Fee line	Amount	Provenance
Class I device registration (查驗登記)	TWD 15,000	Verified
Class II device registration (查驗登記)	TWD 58,000	Verified
Class III device registration (查驗登記)	TWD 100,000	Verified
Export-only device registration	TWD 15,000	Verified

20 more fee lines on the full schedule · 24 of 24 rows source-verified

Registration timeline

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Taiwan Food and Drug Administration (TFDA) review clocks and planning ranges · 3-class (I, II, III) classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Registration)	80 days	3-7 months	Verified
Class II(Registration)	140 days	9-14 months	Verified
Class III(Registration with clinical data)	200 days	1-1.5 years	Verified
No-predicate device(Registration of a device with no similar marketed product)	220 days	1-2 years	Verified

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(80 days)
5Registration Approval(1-2 weeks)

Latest regulation news

All Taiwan regulation news →

Newest official TFDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 10TFTFDATaiwan FDA Announces Amendments to Articles 4 and 14 of the Regulations Governing Medical Device Recalls

Taiwan Aug 3TFTFDAAnnouncement of the 2026 Medical Device Standards Recognition List and Historical Repealed Recognized Standards List

Taiwan

Key regulations

All 30 Taiwan regulations →

Official TFDA rules and guidance · 30 of 30 documents linked to official sources

醫療器材行政規費收費標準Standards for Medical Device Administrative Fees

GeneralVerified

Regulations Governing Border Inspection and Examination of Imported Medical DevicesRegulations Governing Border Inspection and Examination of Imported Medical Devices

RegistrationVerified

Classification SystemApplication for the Classification of Medical Devices

ClassificationVerified

L0030120 AnnexMedical Device Classification Items — Official Annex

ClassificationVerified