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: 11-13 months (excluding timeline required for device classification, QSD conformity assessment, product testing, and/or local clinical trial – whenever applicable).
On-Site Audit: on-site audit is not necessary except for high-risk products (such as heart valves). For most devices, however, a paper-based quality system review called QSD will be required.
Local test is not required.
Local Clinical Evaluation or Studies is only required in few cases (due to ethnicity or specific medical devices), but if clinical trials from other countries is available and follow the GCP, local clinical trial can be waived. Also, if they have a predicate in Taiwan, clinical trial might not be required at all.
LOCAL FEES (New Application):
Medical Device (with predicate device):
Class I: USD 540
Class II: USD 2070
Class III: USD 3570
Medical Device (without predicate device): USD 4650
In-vitro Diagnostics (with predicate device): USD 1430
In-vitro Diagnostics (without predicate device): USD 2500
Medical Device Listing: USD 360
Medical device classification: USD 107
GMP/QSD Conformity Assessment: USD 2150
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.
- Abridged Pathway – there are 8 low-risk devices and 34 low/moderate-risk devices that are eligible for this pathway.
- Regular registration pathway – any other devices that are ineligible in previous pathways will go with this pathway.
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.