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IVD Classification

IVDs as a distinct category​

In vitro diagnostic (IVD) medical devices are classified under a separate set of rules from general medical devices, reflecting the distinct risk profile of diagnostics — where a wrong result can lead to incorrect treatment decisions rather than direct physical harm.

An IVD is a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system intended to be used in vitro for the examination of specimens derived from the human body for the purpose of providing information about a physiological or pathological state, congenital abnormality, or to determine safety and compatibility with a potential recipient.

IVDs include test kits, laboratory analysers, point-of-care devices, and self-testing devices such as home pregnancy tests or glucose meters.

IVD classification factors​

IVD classification in Singapore considers:

  • The intended use — what is being detected or measured and for what clinical purpose;
  • The risk if the result is incorrect — false positive or false negative, and the clinical consequences;
  • Whether the device is for self-testing (used by a lay person without professional supervision);
  • Whether the device is for blood/tissue donor screening or for confirmatory testing of HIV or other high-risk infectious agents.

IVD Classes​

Class A IVD​

Lowest-risk IVDs — those where an incorrect result poses minimal risk to the individual or public. Exempt from registration; product notification only.

Examples:

  • General chemistry reagents (cholesterol, glucose for general wellness monitoring, not diagnosis)
  • Urine dipstick tests for general urinalysis
  • Non-medical-purpose IVDs (e.g. IVDs used only for research or quality control)

Class B IVD​

IVDs where incorrect results carry a moderate level of individual risk, but public health risk is low.

Examples:

  • Self-testing glucose meters for diabetes management
  • Home pregnancy tests
  • Urinary tract infection self-test kits
  • General haematology reagents

Class C IVD​

IVDs where incorrect results carry significant individual risk, or where there is a moderate public health risk.

Examples:

  • HIV antibody tests (not for blood donor screening — that is Class D)
  • HbA1c testing systems
  • PSA (prostate-specific antigen) assays
  • Companion diagnostics for therapeutic decision-making
  • Near-patient testing devices
  • Self-testing devices for infectious diseases with significant individual consequences

Class D IVD​

Highest-risk IVDs — those used for blood/tissue donor compatibility testing, or where incorrect results carry the highest risk of serious harm to individuals or public health.

Examples:

  • Blood donor HIV screening IVDs
  • Blood/tissue donor compatibility testing (ABO, Rh, crossmatch)
  • Confirmatory HIV diagnostic IVDs
  • HBsAg (Hepatitis B surface antigen) IVDs for blood donor screening
  • Blood grouping reagents

IVD analysers vs IVD assays​

A distinction that affects expedited route eligibility: IVD analysers (the instrument/platform) and IVD assays (the reagent kits run on the analyser) may have different classifications and different eligibility for expedited registration routes.

Notably, the EDR route exclusions for high-risk IVDs apply specifically to IVD assays for HIV testing and blood/tissue donor compatibility testing — but not to IVD analysers intended for those applications. See Evaluation Routes.

IVD grouping​

IVDs have specific grouping options that differ from general devices:

  • IVD Test Kit: groups individual IVD test kit components under one registration
  • IVD Cluster: groups multiple IVD assays with the same intended use on different platforms
  • IVD Analyser: groups multiple analyser models under one registration

See Grouping Types for full detail.

Official sources​