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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):
Factors from section 6 that may affect medical device classification are the following (page 5):
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.
Contact Asia Actual for more information about the Malaysia classification system.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Inquiry@asiaactual.com
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