Medical Device Classification in Malaysia: Risk-Based System and AMDD Alignment

Medical Device Classification in Malaysia: Risk-Based System and AMDD Alignment

The Medical Device Authority (MDA) in Malaysia manages the classification system for medical devices and In Vitro Diagnostic (IVD) products, as established under the Medical Device Regulation 2012. This system is closely aligned with the ASEAN Medical Devices Directive (AMDD), employing a risk-based approach that determines the level of regulatory scrutiny required for market entry.

General Medical Device Risk Classification

Medical devices (excluding IVDs) are classified into five categories, ranked from lowest to highest risk:

• Class A: Low risk (e.g., non-invasive items like bandages or surgical retractors).
• Class B: Low to moderate risk.
• Class C: Moderate to high risk.
• Class D: High risk (e.g., life-sustaining or implanted devices).
• Combination Devices: A fifth category for products that combine a medical device with a drug, biological product, or other regulated component.

Factors Determining Classification

The MDA uses a set of general principles to assign a classification, primarily based on the risk associated with the device at the point of usage. Key factors include:

• Intended Purpose and Action: The intended use and whether the device delivers medicine or energy to the patient, or is intended to have a biological effect.
• Contact and Invasiveness: The duration of contact with the body, and the degree of, and site of, invasiveness into the body.
• Effects: Whether the effects are local versus systemic, and whether the device comes into contact with injured skin.
• Design and Use: The effectiveness of risk management techniques applied during design, manufacture, and use.

IVD Device Classification

IVD devices are categorized separately but also use the four risk classes (A, B, C, D), from lowest to highest risk. The risk level for IVDs is determined by:

• Intended Use: The diagnostic application.
• User Expertise: The required expertise of the intended user.
• Diagnostic Importance: The importance of the information provided by the diagnostic test.
• Impact of Results: The potential impact of the test results on patient health (e.g., an HIV blood test is high-risk Class D, while a pregnancy test is lower-risk Class B).

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Classification of Software

• Embedded Software: Software incorporated into a medical device that drives or influences its use (e.g., image enhancement software) is classified the same as the medical device itself.
• Standalone Software: Software that functions independently and falls within the definition of a medical device is classified on its own merits, using the same active device classification rules. Standalone software is generally considered an active device.