In Vitro Diagnostics (IVD)

IVD Regulation in Malaysia

In vitro diagnostic medical devices (IVDs) are regulated under Act 737 and the Medical Device Regulations 2012, using a classification system based on GHTF SG5 IVD guidance with Annex II lists for high-risk IVDs.

This page covers IVD-specific obligations beyond the classification framework (see IVD Classification for classification detail).

Performance Evaluation — The Core of IVD Conformity

For IVDs, performance evaluation is the central conformity assessment activity. It encompasses:

Analytical Performance

The ability of the IVD to correctly measure what it is intended to measure:

Parameter	Description	Key Standard
Accuracy/Trueness	Closeness of test result to true value	ISO 5725, ISO 17511
Precision	Repeatability (within-run) and reproducibility (between-run, between-day)	EP05 (CLSI)
Analytical sensitivity	Limit of Detection (LoD) and Limit of Quantitation (LoQ)	EP17 (CLSI)
Analytical specificity	Absence of interference from cross-reacting substances	EP07 (CLSI)
Linearity	Range over which the relationship between result and concentration is linear	EP06 (CLSI)
Measuring interval	Reportable range of the device
Stability	Reagent, calibrator, and in-use stability

Clinical Performance

The ability of the IVD to correctly identify patients with or without the target condition:

Parameter	Description
Diagnostic sensitivity	True positive rate — proportion of diseased patients correctly identified as positive
Diagnostic specificity	True negative rate — proportion of non-diseased patients correctly identified as negative
Positive predictive value	Probability that a positive result is a true positive
Negative predictive value	Probability that a negative result is a true negative

Clinical performance studies must use samples from clinically well-characterised patients and be compared against an appropriate reference method or clinical reference standard.

Metrological Traceability

For quantitative IVDs, MDA expects that calibrators are traceable to:

• International reference materials (where available — check JCTLM database)
• International reference measurement procedures
• SI units where applicable

Traceability documentation must be included in the technical file.

Reference Interval Studies

For IVDs providing results compared to reference intervals, manufacturers should:

• Provide reference intervals relevant to the Malaysian and/or Asian population where possible
• Reference published studies on Asian population reference intervals
• Justify the use of reference intervals derived from non-Asian populations if Malaysian data is unavailable

Reference intervals derived entirely from European or North American populations may not be appropriate for Malaysian patients.

Kit Components

For kit-based IVDs, the technical file must cover all components supplied:

• Reagents (all formulations)
• Calibrators
• Controls
• Diluents/buffers
• Ancillary materials

Each component's composition, function, and stability must be documented.

Instrument-Reagent Compatibility

For IVDs designed to work with a specific analyser or instrument platform:

• Validated combinations of reagent lots and instrument models must be specified
• Performance data must be generated on the specific instrument(s) intended for use

Post-Market Surveillance for IVDs

IVD-specific PMS activities include:

• Monitoring of external quality assurance (EQA) scheme results
• Tracking of complaints related to anomalous results
• Literature surveillance for emerging data on the analyte and clinical condition
• Monitoring of competitor recalls and safety alerts for similar devices
• Post-market performance follow-up studies for Annex II IVDs

Labelling for IVDs

IVD labels and IFUs must include (in addition to general labelling requirements):

• Intended analyte and matrix (specimen type)
• Principles of the procedure
• Analytical measurement range and units
• Limitations of the procedure
• Expected values / reference intervals
• Interferences identified
• Instructions for quality control

See Labelling Requirements for the complete list.