How are devices classified in Malaysia?
The Malaysian Medical Device Authority (MDA) created a classification system based on Medical Device Regulation 2012, which is closely aligned with the ASEAN Medical Device Directive. The risk level is dependent on the intended use, effectiveness of risk management techniques applied during design, manufacture and use, its intended user(s), mode of operation, and technologies used.
Other factors that may affect medical device classification include:
- The duration of contact of the device with the body
- The degree of, and site of, invasiveness into the body
- Whether the device deliver medicines or energy to the patient
- Whether the device is intended to have a biological effect on the body
- Intended action on the human body
- Local versus systemic effects
- Whether the device comes into contact with injured skin
- Whether for diagnosis or treatment
- Whether the device is reusable
- Combination of devices
Malaysia device classification tiers
Products are classified into one of the following, from lowest to highest risk:
- Class A - Low risk. Examples: surgical retractors, tongue depressors.
- Class B - Low-moderate risk. Examples: hypodermic needles, suction equipment.
- Class C - Moderate-high risk. Examples: Lung ventilators, orthopedic implants.
- Class D - High risk. Examples: Heart valves, implantable defibrillator.
Malaysia IVD classification tiers
IVD risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, a pregnancy test is Class B whereas an HIV Blood Test is Class D. IVDs are categorized separately from other medical devices and are further subdivided into one of the following, from lowest to highest risk:
- Class A - Low Individual Risk and Low Public Health Risk. Examples: Clinical Chemistry Analyzers.
- Class B - Moderate Individual Risk and/or Low Public Health Risk. Example: Vitamin B12, Pregnancy Self-Testing, Anti-Nuclear Antibody, Urine Test Strips.
- Class C - High Individual Risk and/or Moderate Public Health Risk. Examples: Blood Glucose Self-Testing, HLA Typing, PSA screening, Rubella.
- Class D - High Individual Risk and High Public Health Risk. Example: HIV Blood Donor Screening, HIV Blood Diagnostic.
