IVD Registration
IVD Registration Framework
IVDs are registered under the same Act 737 framework as other medical devices, but with IVD-specific technical documentation requirements reflecting the performance-based nature of IVD conformity assessment.
Registration class (A through D via Annex II) determines the depth of required evidence. See IVD Classification for classification details.
IVD-Specific Technical Documentation
In addition to the standard device registration sections, IVD registrations must include:
Performance Evaluation Dossier
Analytical Performance Studies
| Study | What It Demonstrates |
|---|---|
| Accuracy / Trueness | Closeness of results to true value (ISO 5725) |
| Precision | Repeatability and reproducibility |
| Analytical sensitivity | Lowest detectable amount (LoD, LoQ) |
| Analytical specificity | Absence of cross-reactivity, interference |
| Linearity / measuring range | Range over which results are linear |
| Interference studies | Effect of common interferents (haemolysis, lipaemia, icterus) |
| Stability | Reagent stability under claimed storage conditions and in-use stability |
Clinical Performance Studies
| Study | What It Demonstrates |
|---|---|
| Diagnostic sensitivity | Proportion of true positives correctly identified |
| Diagnostic specificity | Proportion of true negatives correctly identified |
| Clinical study design | Appropriate patient population, reference method, blinding |
For Annex II List A (Class D) IVDs, particularly blood screening assays, large-scale clinical performance studies with internationally accepted reference methods are required.
Reference Measurement Traceability
- For quantitative IVDs: traceability of calibrators to international reference materials (SI units where applicable)
- Reference to JCTLM (Joint Committee for Traceability in Laboratory Medicine) listed reference measurement procedures where available
Quality Control Information
- Description of controls supplied with the device
- Recommended QC frequency and acceptance criteria
- External Quality Assurance (EQA) programme participation recommendations
Labelling for IVDs
- Intended analyte and clinical use
- Specimen type(s) accepted
- Analytical measurement range
- Units of measurement
- Limitations of the procedure
- Expected values / reference intervals (where applicable)
Self-Testing IVDs
IVDs intended for use by laypersons require additional documentation:
- Usability/human factors study demonstrating safe use without professional training
- Lay-friendly IFU validated with target user population
- Additional clinical performance data in self-testing conditions
Point-of-Care IVDs
Near-patient testing IVDs used outside of central laboratories (e.g. emergency departments, GP clinics) are typically classified as Annex II List B and require:
- Performance data generated in the intended use environment (not just central lab)
- Training requirements documented
Rapid antigen tests and lateral flow assays for infectious diseases frequently fall into Annex II List B or A. Ensure clinical performance data is generated on Malaysian or regionally-relevant clinical samples where possible.