Taiwan’s regulatory framework for medical device and in vitro diagnostic (IVD) labelling is governed by the Medical Devices Act, with detailed requirements published by the Taiwan Food and Drug Administration (TFDA). Proper labelling is mandatory for all imported and domestically manufactured devices before they may be sold or distributed in Taiwan.

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1. Legal Basis

 

Under Medical Devices Act Article 32, all medical devices must include:

·         Chinese-language labels on the smallest sales unit.

·         Chinese instructions for use (IFU) provided before sale, wholesale, or retail.

·         Exceptions apply only when TFDA grants approval due to compliance difficulty.

 

2. General Labelling Requirements (All Medical Devices)

 

TFDA requires that draft labels, packaging, and IFUs be submitted during product registration. Key mandatory elements include:

Required Information

·         Product name (Chinese + English)

·         License or registration number

·         Manufacturer name and address

·         Importer (medical device firm) name and address

·         Manufacture date and expiry date / shelf life

·         Batch/lot number or serial number

·         Warnings, precautions, and usage limitations

·         Storage and environmental conditions

·         Model and specifications

·         Intended use / indications

·         Contraindications and foreseeable adverse effects

·         Instructions for use and installation (if applicable)

Formatting Requirements

·         Chinese text must be primary; foreign text must be smaller.

·         Minimum font size: 7‑point.

·         Warnings must be highlighted using red text, red frames, or bold black font.

 

3. Additional Requirements for IVD Medical Devices

 

TFDA provides a separate, more detailed guideline specifically for IVDs, covering both reagents and instruments. IVD IFUs must include the following elements (summarized from TFDA’s “Principles of Preparing Instructions for IVDs”):

Key IVD-Specific Labelling Elements

·         Intended use (analyte, clinical purpose, qualitative/quantitative, target population)

·         Specimen type and handling

·         Test principle

·         Reagent composition and stability

·         Calibration and quality control procedures

·         Performance characteristics (sensitivity, specificity, accuracy, precision, LoD, linearity)

·         Reference intervals

·         Limitations and interfering substances

·         Required ancillary equipment

·         Waste disposal precautions

·         Statement: “For in vitro diagnostic use only.”

These requirements ensure that laboratories and healthcare professionals receive complete technical and safety information necessary for accurate and reliable testing.

 

4. UDI Requirements

 

Taiwan has implemented Unique Device Identification (UDI) requirements for certain device classes. Manufacturers must upload UDI data to the Taiwan UDI Database (TUDID) according to TFDA’s phased implementation plan.

 

5. Submission Requirements

 

During product registration, applicants must provide:

·         Two copies of draft labels, packaging, and IFUs.

·         For imported devices, the Chinese IFU must accurately translate the original manufacturer’s documentation.

 

Conclusion

Taiwan’s labelling requirements for medical devices and IVDs are comprehensive and closely aligned with international standards. Compliance ensures product transparency, user safety, and regulatory approval. Manufacturers and importers should prepare clear, accurate, and fully Chinese-language labelling materials to meet TFDA expectations.