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 requirements covered30 regulations trackedAug 2026 fees reviewed

Search the device database Run the classification agent

Read the maintained Taiwan market guide on Pure Global ↗

Everything we track for Taiwan

Browse by resource instead →

Medical device registration database

Search official TFDA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official TFDA regulations and guidance documents.

Government registration fees

Review current TFDA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely TFDA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent TFDA policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary TFDA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Taiwan requirements.

AI similar registered product finder

Describe a device and find comparable products in the TFDA registration database.

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 78 source-linked facts →

24 of 25 research dimensions currently covered · 28 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

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…
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.…

2 source-linked facts

Checked 2026-08-28

Open details →

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

Open details →

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

Open details →

D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-25

Open details →

D05

Registration pathways

Verified

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…
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…

3 source-linked facts

Checked 2026-08-25

Open details →

D06

Reliance & recognition

Verified

Country-of-origin free-sale certificate: Imported device applications rely on a free sale certificate (出產國許可製售證明) defined as a document issued by the highest health authority of the country of manufacture certifying that the devic…
Foreign manufacturer letter of authorization: Imported device applications require a manufacturer's letter of authorization (國外原廠授權登記書), defined as a document issued by the foreign manufacturer of the imported device authorising an age…

2 source-linked facts

Checked 2026-08-25

Open details →

D07

Economic-operator roles

Verified

Local agent / licence holder for foreign manufacturers: Foreign manufactured devices are placed on the market through a locally registered medical device firm acting as importing agent and licence/filing holder: QMS inspection and manufacturing…
Licence holder transfer: A change of licence owner (許可證所有人, transfer/移轉) is an itemised change requiring prior approval from the central authority with the documents of Annex 4 and the change fee; the official proc…

5 source-linked facts

Checked 2026-08-28

Open details →

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

Open details →

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

Open details →

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

Open details →

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

Open details →

D12

QMS, audit & inspection

Verified

QMS and manufacturing permit: Manufacturers must establish a QMS under the QMS Regulations, pass central authority inspection and obtain a manufacturing permit (製造許可) before manufacturing; foreign manufacturing sites ar…
Manufacturing permit validity and extension: The QMS manufacturing permit is valid for three years. Extension must be applied for between 12 and 6 months before expiry, each extension being at most three years; if the applicant files…

7 source-linked facts

Checked 2026-08-28

Open details →

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 2026-09-07

Open details →

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

Open details →

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

Open details →

D16

Approval validity & renewal

Verified

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…
Expiry consequence: If the extension is not applied for before expiry, a fresh registration under Articles 5 and 6 of the licence regulation is required and a new licence number is issued on approval; for Clas…

5 source-linked facts

Checked 2026-08-28

Open details →

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

Open details →

D18

UDI, listing & traceability

Verified

Source and flow records: For device categories announced by the central authority (risk based), medical device firms and medical care institutions must establish and keep records of direct supply sources and distri…
Quarterly reporting and UDI use: For announced reporting items, firms and medical care institutions must report electronically to the central authority's system by the 20th of January, April, July and October each year (in…

5 source-linked facts

Checked 2026-08-28

Open details →

D19

Clinical investigation & performance

Verified

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…
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…

3 source-linked facts

Checked 2026-08-25

Open details →

D20

Special access & derogation

Verified

Special (project) approval grounds: Central authority project approval (專案核准) exempts manufacture/import from registration (Art. 25) in six situations: (1) prevention/diagnosis/treatment of life threatening or seriously disab…
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…

4 source-linked facts

Checked 2026-08-28

Open details →

D21

Manufacturer PMS

Verified

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…
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…

3 source-linked facts

Checked 2026-08-28

Open details →

D22

Vigilance & incident reporting

Verified

Reportable serious adverse events: Device firms (licence holders/filers) and medical care institutions that discover a serious adverse event must report it to the central authority (or its commissioned body). A serious adver…
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…

3 source-linked facts

Checked 2026-08-25

Open details →

D23

Recall, FSCA & market surveillance

Verified

Recall obligation: Where a licence is revoked, the device is defective or unregistered, or human health risk is suspected, the licence holder/filer must immediately notify medical care institutions, other dev…
Recall grades and completion deadlines: Recalls are graded: Grade 1 (serious harm or risk of serious harm to user health), Grade 2 (no harm / not serious harm), Grade 3 (revoked manufacturing permit and other listed cases). Compl…

5 source-linked facts

Checked 2026-08-28

Open details →

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

Open details →

D25

Submission communications & appeal

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

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

Full registration timeline →

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