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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 (comprising analytical performance and clinical performance studies) is the primary conformity assessment pathway and central evidence requirement for demonstrating safety and performance. It encompasses:

Analytical Performance​

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

ParameterDescriptionKey Standard
Accuracy/TruenessCloseness of test result to true valueISO 5725, ISO 17511
PrecisionRepeatability (within-run) and reproducibility (between-run, between-day)EP05 (CLSI)
Analytical sensitivityLimit of Detection (LoD) and Limit of Quantitation (LoQ)EP17 (CLSI)
Analytical specificityAbsence of interference from cross-reacting substancesEP07 (CLSI)
LinearityRange over which the relationship between result and concentration is linearEP06 (CLSI)
Measuring intervalReportable range of the device
StabilityReagent, calibrator, and in-use stability

Clinical Performance​

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

ParameterDescription
Diagnostic sensitivityTrue positive rate — proportion of diseased patients correctly identified as positive
Diagnostic specificityTrue negative rate — proportion of non-diseased patients correctly identified as negative
Positive predictive valueProbability that a positive result is a true positive
Negative predictive valueProbability 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.

Complete the truncated section: 'Labelling for IVDs — In addition to general requirements, IVD labels and IFUs must include: Analyte and specimen type, Analytical measurement range, Reference intervals (where applicable), Interferences, Principles of the procedure, and a warning or statement if the IVD is for in vitro use only. See Labelling Requirements for full detail on mandatory label elements and language requirements for IVDs supplied in Malaysia.'