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IVD Classification

In-vitro diagnostic (IVD) devices follow a distinct set of classification rules under Decree 98/2021 and Circular 14/2020, although the same Type A–D framework applies.

What is an IVD?​

An IVD medical device is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software, or system — whether used alone or in combination — intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations, solely or principally for the purpose of providing information:

  • Concerning a physiological or pathological state
  • Concerning a congenital abnormality
  • To determine safety and compatibility with potential recipients
  • To monitor therapeutic measures

IVD classification rules​

IVD devices are classified based on the risk to the individual and to public health, applying ASEAN AMDD-derived rules:

ClassRisk basisExamples
Type A (IVD)Low individual risk, low public health riskGeneral laboratory instruments, specimen containers, staining reagents
Type B (IVD)Moderate individual risk, low public health riskPregnancy tests, blood glucose self-monitoring (home use for known diabetics)
Type C (IVD)High individual risk or moderate public health riskBlood glucose monitoring (diagnosis), coagulation testing, PSA testing, HbA1c
Type D (IVD)High risk to individual and public healthHIV, Hepatitis B/C detection; blood donor screening; TB confirmation

Key IVD classification factors​

  • Intended use population — professional laboratory vs. lay person self-testing
  • Public health impact — devices used for blood bank screening or detecting highly infectious diseases automatically attract the highest class
  • Whether used for diagnosis or monitoring — a glucose monitor used for monitoring an established condition may be lower class than one used for diagnosis

Self-testing IVDs​

IVD devices intended for self-testing by lay persons without professional healthcare support are generally elevated by one class compared to the equivalent professional-use device, due to the increased risk of user error.

Near-patient testing​

Point-of-care IVD devices — designed for use outside a laboratory setting, near the patient — are assessed on their intended use and risk profile. They do not automatically attract a higher class but the lay-person use factor may apply.

Regulatory pathway​

The IVD classification determines the same declaration or registration pathway as for other device types: