IVD Product Registration in Taiwan

Medical Devices are overseen by the Taiwan Food and Drug Administration (TFDA), a division of the Ministry of Health and Welfare. As of May 2021, the regulatory system will also be governed by the new Medical Devices Act.

According to the Medical Devices Act, the term “medical devices” refer to 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:

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

Taiwan IVD Device Registration Process

The first step to determining the regulatory pathway is to classify the product into one of the following four classifications:

• Class I (Low Risk) (Not Registrable)
• Class II (Medium Risk) (Not Registrable)
• Class III (High Risk)
• Class III New (No predicate device previously approved by TFDA)

Class III, and New IVD applications will undergo two stages of review: Administrative and Technical. Class I and II IVD products do not require registration.

Required Documents

Documents required as part of the application include:

• Application form
• Copies of Chinese labeling, instruction for use, packaging inserts.
• A copy of Pharmaceutical License for Medical Device Manufacturer/Distributor/Agent.
• Truth and Accuracy Statement.
• Free Sale Certificate issued by the health authority by the country of origin (for imported products) and authorization letter issued by manufacturer.
• Copies of preclinical test, quality control procedure and test reports.
• Copies of product structure, material, specifications, intended use and drawings.
• A copy of GMP/QSD Compliance Letter.
• Literature Review (Class III IVDs and New products only).
• Clinical Investigation Reports (Class III IVDs and New products only).
• Radioactive safety information (if applicable).

Clinical data is only required for Class III IVDs and New products.

Once issued, the License is valid for 5 years. Licenses in Taiwan are transferrable and will need to be completed by both the transferor and the transferee jointly.

Quality System Requirements

Before manufacturers can begin marketing their Class I, Class II, or III products in Taiwan, they will need to provide evidence of a Quality System Documentation (QSD) in accordance with Taiwan’s Good Manufacturing Practices (GMP). This process can take up to up to 10 months to acquire and can be done alongside the application review. Approvals will not be issued before the QSD is approved. QSD is not required for Class I non-measuring, non-sterile products.