Medical Device Registration and Approval in Taiwan

General country-specific regulatory information is provided on this page for medical device registration and approval in Taiwan. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Taiwan, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Taiwan

REGULATORY AUTHORITYTaiwan Food and Drug Administration – Medical Devices Division (Taiwan FDA or TFDA)

CLASSIFICATION SYSTEM: Medical Devices and IVDs: Class I/II/III

TIMEFRAME: New Registration: 8-11 months (excluding timeline required for device classification, QSD conformity assessment, product testing, and/or local clinical trial – whenever applicable).

LOCAL FEES (New Application):  

Medical Device (with predicate device)

Class I: USD $340

Class II: USD $850

Class III: USD $1290

Medical Device (without predicate device): USD $2202

In-vitro Diagnostics (with predicate device): USD $1355

In-vitro Diagnostics (without predicate device): USD $2375

*excluding fees required for medical device classification and QSD conformity assessment

LOCAL FEES (Manufacturer):  All medical device dealers who are dealing with activities such as wholesale, import, or export must obtain medical device dealer permit license.

LICENSE VALIDITY: 5 Years

LICENSE TRANSFER: License transfer is possible (both new and current licensor must submit the application to Taiwan FDA).

AUTHORIZED REPRESENTATIVE: Foreign manufacturer should appoint a legal entity located in Taiwan as their authorized representative. This authorization will allow the company to apply for product registration.

SPECIAL REQUIREMENTS:

On-Site Audit: On-site audit is required as part of registration process except for Class I medical devices (non-sterile, without measuring function). However, Taiwan FDA has introduced Technical Cooperation Program (TCP) in which on-site inspection can be waived.

Local Tests/Permit: Various parameters are required to be tested locally, including but not limited to, biocompatibility, electrical safety, and electromagnetic compatibility (EMC).

Local Clinical Evaluation or Studies: Local clinical studies are required especially for Class II medical devices that have no predicate device and Class III medical devices. The Taiwan FDA will determine whether a local clinical study is required or not. 

Last updated on November 2, 2020

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