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.
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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