Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration
On November 16, 2023, the Medical Device Authority of Malaysia (MDA) published an infographic
related to the medical device registration for In-Vitro Diagnostic (IVD) Medical Devices, where the
MDA illustrated the possible ways to register an IVD Analyzer.
Based on the infographic, the approaches below can be applied to register an IVD Analyzer:
1) IVD Analyzer
This applies to instruments that are specifically intended to be used in an in vitro diagnostic
procedure. These instruments will fall under as class A of medical devices, whereas reagents and
kits are classified according to their own classification as they are registered separately.
- Enzyme immunoassay analyzer, PCR thermocycler, microplate reader, clinical chemistry analyzer.
- Instrument for automated purification of nucleic acids and automated nucleic acids extractor.
2) Analyzer in combination with the reagents, calibrators, controls, buffer/ washing solutions.
The classification of this combination will follow the highest reagent’s classification. For examples:
- Clinical Chemistry Analyzer + Reagent assay + Diluent
- Immunoassay Analyzer-Coagulation + D-Dimer reagent + D-Dimer control
3) Interdependent Analyzer with the following conditions:
This applies to instruments with an independent measuring function but does not use any
additional reagents. They will be classified in accordance with the intended purpose of the analysis
(including instrument controls or instruments quality control).
- Cell counting analyzers used in haematology, ion selective electrodes, instruments measuring
blood gases or glucose via its sensors, specific gravity measurements in urine analysis, mass
spectrophotometer for bacteria identification, erythrocyte sedimentation rate analyzer etc.
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