IVD Classification
Overview
In-vitro diagnostic (IVD) devices — reagents, instruments, and systems used to examine specimens from the human body — follow a separate classification framework from general medical devices, although the same four-class (A–D) structure applies. IVD classification is based on the public health risk posed by incorrect results and the individual patient risk from the intended use.
IVD Classification Framework
Indonesia's IVD classification aligns with the ASEAN IVD classification rules, which in turn draw from GHTF guidance. Classification considers two primary factors:
- Individual risk — risk to the individual patient from an incorrect result
- Public health risk — risk to the population (e.g. communicable disease testing)
IVD Risk Classes
| Class | Risk Profile | Examples |
|---|---|---|
| A | Low individual risk, low public health risk | General chemistry tests (cholesterol, glucose for monitoring), blood grouping reagents for non-transfusion use |
| B | Moderate individual risk OR moderate public health risk | Blood glucose meters and test strips (self-testing), pregnancy tests, urinalysis reagents, blood grouping for transfusion |
| C | High individual risk OR significant public health risk | HIV screening tests, hepatitis B/C screening, HbA1c testing, tumour markers, genetic testing for inherited disease |
| D | Very high individual/public health risk, or high probability of serious consequence from error | HIV confirmatory tests, blood screening for transfusion-transmissible infections (HIV, HCV, HBV), BSE/CJD testing |
Key Classification Considerations for IVDs
Point-of-Care (POCT) Devices
Point-of-care tests intended for professional use or self-testing by lay users receive close scrutiny. IVDs for lay self-testing are generally classified at a higher risk class than equivalent laboratory instruments, reflecting the user's lack of clinical training.
Molecular Diagnostics (PCR, NGS)
High-sensitivity molecular tests — particularly those for communicable diseases — are typically Class C or D in Indonesia. Comprehensive analytical performance validation data is required in the dossier.
Combination Analysers
Multi-parameter analysers (e.g. haematology analysers, blood gas analysers) are classified based on the highest risk application they are intended to perform.
AI/ML-Enhanced IVDs
Artificial intelligence or machine learning components used to assist diagnostic interpretation are classified based on the underlying clinical use. See IVD Digital Platforms for additional considerations.
Documentation for IVD Registration
IVD dossiers follow the ASEAN CSDT structure, with IVD-specific modules:
| Document | Notes |
|---|---|
| Analytical performance data | Accuracy, precision, sensitivity, specificity, linearity, interference |
| Clinical performance data | Data from clinical studies demonstrating clinical sensitivity and specificity |
| Reference interval studies | Particularly important for quantitative assays |
| Quality control procedures | Internal and external QC requirements |
| Calibrator traceability | ISO 17511 / ISO 18153 traceability chain |
| Intended user profile | Professional lab vs lay self-test |
IVD Labeling
IVD labeling must comply with all standard Indonesian labeling requirements (Bahasa Indonesia mandatory for all safety and usage information) plus IVD-specific content such as:
- Analytical sensitivity and specificity statements
- Calibration requirements and frequency
- Interference and cross-reactivity warnings
- Storage and stability conditions
- Reference ranges or expected values