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 AUTHORITY: Taiwan 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