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, depending on the pathogen and clinical context. Ensure clinical performance data is generated on Malaysian or regionally-relevant clinical samples where possible, as sensitivity and specificity can vary significantly by population and specimen quality. For pathogenic agents endemic in Malaysia (e.g., dengue, tuberculosis), performance data from Malaysian clinical sites is strongly preferred.
Clinical performance studies should be designed with adequate statistical power (typically 80–90%) to demonstrate acceptable diagnostic sensitivity and specificity. For blood screening assays (Annex II List A / Class D), minimum sample sizes are typically in the thousands (exact numbers vary by assay type). For Annex II List B IVDs, smaller but still statistically robust sample sizes are acceptable. For self-testing IVDs, ensure the study population includes a representative sample of the intended lay user population. Provide sample size justification and statistical analysis plan with your dossier.