In June 2026, the Taiwan Food and Drug Administration (TFDA) released two guidance documents outlining the registration and performance evaluation requirements for C-Reactive Protein (CRP) Assays and Antimicrobial Susceptibility Test (AST) Systems.
The guidance document for C-Reactive Protein (CRP) assays is a revision of the version published in May 2014.
Read the full guidance here:
https://www.fda.gov.tw/TC/siteListContent.aspx?sid=11652&id=50893
Purpose of the Guidance Documents
To provide registration and performance evaluation requirements for Antimicrobial Susceptibility Test (AST) Systems and C-Reactive Protein (CRP) Assays.
To support a standardized framework for demonstrating the safety, performance, and clinical validity of these diagnostic products under Taiwan’s IVD regulatory framework.
Scope of Application
These guidance documents apply to manufacturers and applicants submitting registration applications for:
- Antimicrobial Susceptibility Test (AST) Systems
- C-Reactive Protein (CRP) Assays
Key Highlights
Guidance for Antimicrobial Susceptibility Test (AST) Systems
Scope
This guidance applies to AST reagents and systems designed to determine the Minimum Inhibitory Concentration (MIC) of antibiotics to assist in clinical treatment decisions for bacterial infections.
The scope excludes:
- Mycobacteria, viral, or fungal susceptibility testing
- Microbial resistance gene detection
- Other test reagents that do not utilize MIC to evaluate antimicrobial susceptibility
Classification
- C.1640 Antimicrobial susceptibility test powder, Class II
- C.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system, Class II
Key Requirements
Product Information
The submission must include detailed documentation covering materials, specifications, intended use, target species and antibiotics, composition/concentrations, and test method principles.
Operational Requirements
Clear descriptions are required for specimen collection and handling, software for automated systems, and a complete list of accessories, including quality control (QC) strains.
Performance Tests
Accuracy must demonstrate ≥90% Essential Agreement (EA) and Category Agreement (CA) against established MIC reference methods, such as ISO 20776-2 and CLSI M52.
Major Discrepancy (MD) and Very Major Discrepancy (VMD) rates must be <3%.
Quality Control requires daily testing with internationally recognized QC strains, with 95% of results falling within the expected range.
Stability data is required for the product under claimed storage conditions, both before and after opening.
Labeling
Specific cautionary statements must be included where required, such as emphasizing that the system is not to be used as the sole basis for critical clinical decisions or that certain discrepancies require alternative validation.
Guidance for C-Reactive Protein Assays
Scope
This guidance applies to C-Reactive Protein (CRP) immunological test systems, which utilize immunochemical techniques to measure CRP levels in serum and other body fluids.
These assays are intended to assist in evaluating the degree of tissue damage in the body.
Classification
- C.5270 C-reactive protein immunological test system, Class II
Key Updates
Categorization
The framework has transitioned from a three-category structure, CRP, hsCRP, and cCRP, to a two-category framework, CRP and hsCRP.
Requirements for cCRP are now integrated into hsCRP specifications.
Analysis Method
For hsCRP measuring range, the definition now focuses on the critical “<1.0 mg/L” lower limit threshold.
Technical Documentation Requirements
Added requirements include:
- Interpretation and precautions
- Performance specifications
- Storage and shelf life
- Limitations of method
The previous requirement for a detailed description when adopting “new technologies or methods” has been removed.
Performance Tests
The precision testing shall include within-run, between-run, within-day, between-day, and total precision assessment and calculation.
Interference testing is explicitly required for both endogenous substances, such as HAMA and Rheumatoid Factor, and exogenous substances, such as additives and common drugs.
Sensitivity testing requires calculation of Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ).
Linearity requirements are now clearly differentiated into Linearity, Measuring Interval, and Reportable Interval, including dilution studies.
Specimen Handling
Detailed disclosure is required for specimen types and storage conditions, including storage temperature, freeze-thaw cycles, and effects of additives.
Method Comparison
Method comparison must adhere to the Guidance for Method Comparison of In Vitro Diagnostic Medical Devices (2023), with testing conducted at the site of intended use by intended users.
Labeling Emphasis
A new mandatory section on “Labeling” requires specific cautionary statements for hsCRP products used in cardiovascular risk assessment.
Reference Updates
Compliance is now mandatory with the relevant TFDA IVD guidance and current CLSI standards, superseding older references.
References
Read to learn more:
- TFDA Announcement No. 1151605243 (Traditional Chinese only)
- Guidance for Antimicrobial Susceptibility Test (AST) Systems
- Guidance for C-Reactive Protein Assays
Implications to Clients
These guidelines establish clear data submission benchmarks that align closely with international standards, including US FDA, ISO, and CLSI.
Manufacturers choosing to deviate from recommended test methods must submit comprehensive reports to demonstrate that their product’s safety and performance remain equivalent to reference standards.
Labeling must be tailored to the device’s specific risks. Where applicable, manufacturers should include warnings stating that results should not serve as the sole basis for clinical decisions or that confirmatory testing may be required.
Manufacturers of AST Systems and CRP Assays should review their technical documentation, performance evaluation data, stability evidence, and labeling to ensure alignment with the latest TFDA expectations.
Effective Date
Jun 09, 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com.