Medical Device Registration in Taiwan

Why Register Your Medical Device in Taiwan

Taiwan is globally recognized for its strengths in the ICT sector and is now rapidly emerging as a hub for innovation-driven biotech and medtech industries. As of December 31, 2023, the combined revenue of Taiwan’s medical device and digital health sectors reached approximately US$6.7 billion (~NT$200 billion), with the medical device industry contributing US$4.9 billion and the digital health sector US$1.8 billion. To support the adoption of new medical technologies, the Taiwanese government is steadily increasing healthcare expenditure.

The Taiwan Food and Drug Administration (TFDA) is the regulatory authority responsible for overseeing the medical device framework. Recognizing the dynamic and diverse nature of the industry, the TFDA implemented the Medical Device Act—separate from the Pharmaceutical Affairs Act—in 2021 to align more closely with international regulatory standards.

TFDA actively collaborates with global regulatory bodies such as the International Medical Device Regulators Forum (IMDRF), Global Harmonization Working Party (GHWP), and APEC Regulatory Harmonization Steering Committee (RHSC). It also hosts the APEC Medical Device Regulatory Science Center of Excellence (CoE) Workshop annually. In 2023, TFDA became an Affiliate Member of IMDRF, further strengthening Taiwan’s integration into the global regulatory ecosystem.

Medical Device Registration in Taiwan

All medical devices—whether manufactured locally or imported—must be registered and approved or listed by the TFDA before they can be marketed in Taiwan. The Division of Medical Devices and Cosmetics within the TFDA is responsible for administering medical device regulations.

Before Medical Device Act implementation, hard-copy dossiers were required to be submitted for most applications. To streamline the application process, the TFDA is developing e-submission systems for regulatory filings. These systems will be rolled out in phases and will become mandatory in the near future.

What You Need to Know About Medical Device Registration in Taiwan?

Options for Foreign Manufacturers

Option 1

Establish a Legal Subsidiary and Hire a Qualified Medical Device Technician. This option allows full control over regulatory processes and market operations

Option 2

A common choice for companies seeking a quicker market entry without setting up a local entity.

Option 3

Appoint an independent 3rd party. Enables flexibility and neutrality in managing regulatory affairs and distribution.

What is considered as a medical device in Taiwan

In Taiwan, the term “medical device” means instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:

Diagnosis, treatment, alleviation, or direct prevention of human diseases.
Modification or improvement of the structure and function of human body.
Control of conception.

The term “In Vitro Diagnostic Device (IVD)” refers to a reagent, instrument, software, or system used to collect, prepare, or test specimens from human body in order to diagnose disease, determine the state of health or other conditions.

Medical Device Classification in Taiwan

Medical devices are classified based on risk level:

Class 1

Low risk

Class 2

Medium risk

Class 3

High risk

Devices are categorized into 16 categories and 1,866 items (as of now), primarily based on intended use and mode of action.

Quality Management System Requirements

Foreign Medical Device Manufacturer

All manufacturers must establish a Quality Management System (QMS) in compliance with the Medical Device Quality Management System Regulations. For imported devices, manufacturing can only begin after:

Passing a Quality System Documentation (QSD) conformity assessment
Obtaining a manufacturing license from the TFDA.

Only the Items announced by TFDA may be exempted from the manufacturing license.

The manufacturers producing low-risk, non-sterile medical devices categorized within the Items as listed in the Annex of Medical Device Quality Management System Regulations, may qualify for an essential application mode.

Additionally, abbreviated application modes are available under international cooperation programs for:

EU Technical Cooperation Programme (TCP)
U.S. manufacturers
Japanese manufacturers

The QSD manufacturing license is valid for 3 years and shall be renewed 6 months to 1 year before expiration.

Medical Device Dealer in Taiwan

For certain devices designated by the TFDA, their medical device dealers must:

Establish a Good Distribution Practice (GDP) system
Comply with the Regulations for Good Distribution Practice of Medical Devices
Obtain a distribution license following a compliance inspection

The importation of these certain medical devices may only begin after receiving a compliance inspection and obtaining a distribution license from the TFDA.

The GDP distribution license is also valid for 3 years and must be renewed 6 months to 1 year before expiration.

Documents Required for Medical Device Product Registration and Listing

	Class 1 Listing	Class 1 Registration
Application Form	✓¹	✓
Instructions of Product²	✓	✓³
Copy of the Medical Device Business Permit	✓
Manufacturing License (QSD)	Δ⁴
Test specifications and methods for preclinical testing and the test reports	Δ⁵
Other documents and information designated by the central competent authority	Δ⁶

Notes:

Only administrative information needs to be entered on the online platform.
Shall include the instructions for use, function, working principle, and composition (or ingredients) of the medical device, which supports product classification.
Not mandatory but often provided. For certain products, a declaration letter may be submitted instead.
Certain TFDA Announced Items can be exempted.
For products announced by TFDA with specified performance requirements.
For products: (1) includes a trademark or third-party name, (2) is imported from China, or (3) references international standards.

		Class 2		Class 3
TFDA-approved SE device(s)		Yes	No⁶	Yes	No⁶
Administrative Documents and Labeling¹		✓	✓	✓	✓
Technical Documents Device Description²		✓	✓	✓	✓
Preclinical V&V Data and QC Data		✓³	✓	✓	✓
Clinical Evidence	Academic and theoretical bases, relevant research reports and data, and CER	SE comparison table	✓	SE comparison table	✓
Clinical Evidence	(Local) Clinical trial report	X⁴	✓⁵	X⁴	✓

Notes:

Including: (a) an application form; (b) a Legalized Certificate of Manufacture and Free Sale from Country of Origin; (c) draft Traditional Chinese labels, instructions, or packaging; (d) original IFU/manual/brochure (i.e., translation basis); (e) an authorization letter; (f) a copy of QSD Manufacturing License; and (g) a copy of Medical Device Business Permit
Documents relating to product structures, materials, specifications, functions, intended uses, and drawings.
Certain TFDA Announced Items can be exempted from Pre-clinical V&V requirements. QC data shall be applicable for all product items.
Some TFDA Announced Items are not eligible for exemption.
Exemption may be applicable if the product and supporting documents meet all the criteria announced by TFDA.
An additional Advisory Committee review may be required for high-risk products, those involving emerging technologies or medical devices without TFDA-approved SE devices and with concerns regarding clinical safety and efficacy.

Importance of Substantial Equivalent Device Identification

Identifying a TFDA-approved substantial equivalent device is a critical step in determining the appropriate registration pathway. This affects:

The application route
The application fee
The TFDA review timeline

The TFDA provides guidance on:

Required documentation for substantial equivalent devices
The substantial equivalence determination process
How to apply for a substantial equivalent determination

Foreign manufacturers can use the TFDA License Database to search for similar approved products. Alternatively, working with a local partner—such as our team—can streamline the process of identifying suitable substantial equivalent devices and navigating the regulatory landscape.

Product License Validity and Listing Requirements

A product license is valid for 5 years.
Applications for license renewal must be submitted within 6 months prior to expiration.
For products eligible for Listing, an annual declaration/report must be submitted each October.

Labeling Requirements

All medical devices sold in Taiwan must have Traditional Chinese labels affixed to the smallest packaging unit for sale and Traditional Chinese Instructions must be provided. These requirements must be fulfilled before sale, wholesale, or retail. Exceptions may apply if approved by the TFDA.

For foreign manufacturer, if Traditional Chinese label and instruction are not initially available in documentations, they shall be drafted or translated based on the original labeling materials such as IFU, user manual and brochure issued by the manufacturer. The translation basis (i.e., original labeling materials) is required to be submitted for verifying the translation.

The TFDA has issued announcement outlining the approval principles, scope of approval, and subsequent change management guidelines for the Traditional Chinese Instructions associated with imported medical device licenses.

Mandatory Chinese Labeling Content

Labels and instructions (or packaging) must include the following:

Product name
License or listing number
Intended use or indications
Manufacturing date and expiration/shelf-life
Model number, specifications, or key components
Warnings, precautions, limitations, or known side effects
Name and address of the license holder and manufacturer
Lot number or serial number
Any other information required by the competent authority

Unique Device Identification and Tracking Management

Medical Device Classification in Taiwan

Class 2 and 3 medical devices shall be labeled Unique Device Identifier (UDI) on its single unit package or directly marked with the UDI. Before placing the product on the Taiwan market, the license holder or listing applicant must upload the required UDI-related product information to the UDI Database, as mandated by the TFDA.

Tracking Management System

For certain medical devices designated by the TFDA, medical device dealers are required to establish and maintain supply and distribution records. Additionally, for specific devices identified by the TFDA, these records must be reported quarterly to ensure traceability and regulatory compliance.

Typical Fees and Timelines

Application		TFDA* Fee	TFDA Turn-around Time announced**
QSD Standard		NT$60,000 (US$2,000)	120 calendar days
QSD Essential		NT$30,000 (US$1,000)	120 calendar days
Class 1 Listing		NT$10,000 (US$333)	not announced***
Class 1 Registration		NT$15,000 (US$500)	80 calendar days
With TFDA-approved predicate	Class 2 Registration	NT$58,000 (US$1,933)	140 calendar days
With TFDA-approved predicate	Class 3 Registration	NT$100,000 (US$3,333)	200 calendar days
Class 2 or 3 Registration w/o TFDA-approved predicate		NT$130,000 (US$4,333)	220 calendar days

*TFDA: Taiwan Food and Drug Administration
** excluding time for submission preparation and inquiry response preparation by the applicant and manufacturing site of the imported medical device.
***Information accurate at the time of publication. Based on internal consultation with the relevant government agency, the estimated timeline may range from 60 to 80 calendar days, though no official duration has been announced.