MDA Malaysia Medical Device Classification
Medical device classification rules in Malaysia are closely aligned with the ASEAN Medical Device Directive.
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.
Frequently
Asked Questions
What are medical device grouping rules in Malaysia?
The Malaysia Medical Device Authority (MDA) provides some guidance on grouping. Grouping allows for a simpler application process, which in turn, is more cost effective and time saving for the manufacturer. Grouping in Malaysia is harmonized with the ASEAN MDD and is centered on three basic rules:
- generic proprietary name;
- manufacturer; and
- common intended purpose.
As in other ASEAN MDD harmonized countries, applications can be submitted under one of the following grouping categories: Single, Family, System, Set, IVD Test Kit, IVD Cluster.
Does classification affect approval timelines in Malaysia?
Depending on the risk level of the product, the MDA audit timeline is as follows (if multiple rounds of issuance are involved, timeline will be extended accordingly). For products with no reference country approval, registration can take 9-18 months.
- Class A: The official time is 2-4 months after the registration materials are submitted.
- Class B: The official time is 3-6 months after the registration materials are submitted.
- Class C and D: The official time is 3-6 months after the registration materials are submitted; the actual timeline is approximately 6-9 months for registration.
How does classification affect medical device registration requirements in Malaysia?
Class A device registrations do not require a Conformity Assessment Body (CAB) and can submit to MDA directly online via the MeDC@St system. Class B,C, and D device registrations must submit to a Conformity Assessment Body (CAB) assessment before submitting to MDA.
