The Malaysian Medical Device Authority (MDA) created a classification system based on Medical Device Regulation 2012 which is closely aligned with the ASEAN MDD. 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.
Products are classified into one of the following, from lowest to highest risk:
The following general principles from section 5 apply (page 4):
The classification of the device is based on the risk associated to it at the point of usage (The risk to patients, users, and other persons)
The risk presented by a particular device depends on:
Its intended purpose
The effectiveness of the risk management techniques applied during design, manufacturing, and use
Its intended user(s)
Its mode of operation
Factors from section 6 that may affect medical device classification are the following (page 5):
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
The ability to be re-used or not,
Combination of devices
IVD Classification Rules
IVDs are categorized separately from other medical devices and are further subdivided into one of the following, from lowest to highest risk:
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.
As the risk increases, more documentation may be required. For more details, contact Asia Actual.
Malaysia Specific Cases – Software
Software that is incorporated into the medical device itself and intended to drive or influence the use of a medical device should be classified the same classification as the medical device (e.g. software which is used for image enhancement).
Software that is independent of any other medical device, it is classified in its own right using the classification rules for medical devices.
Standalone software (to the extent it falls within the definition of a medical device) is deemed to be an active device.
Class A Reusable surgical instruments can also be grouped as a Family if they have the same manufacturer and have a common intended purpose.
Contact Asia Actual for more information about the Malaysia classification system.