IVD Classification
IVDs Under Act 737
In vitro diagnostic (IVD) medical devices are a distinct category regulated under Act 737. An IVD is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, intended to be used in vitro for the examination of specimens derived from the human body — including donated blood and tissue.
IVD Classification Framework
Malaysia's IVD classification is based on the GHTF SG5 IVD classification guidance and uses an Annex-based approach within the Medical Device Regulations 2012:
| Classification | Risk | Approach |
|---|---|---|
| Annex II List A | Very high risk | IVDs for blood group typing and infectious disease screening of blood/organ donations |
| Annex II List B | High risk | IVDs for specific pathogens, self-testing IVDs, near-patient testing |
| Self-testing IVDs | Moderate-high | Devices intended for use by laypersons without professional training |
| General IVDs | Lower risk | All IVDs not in Annex II or self-testing |
These broadly correspond to the Class A–D framework:
| IVD Category | Approximate Class | Examples |
|---|---|---|
| General IVD | Class A / B | Clinical chemistry reagents, routine urine dipsticks |
| Annex II List B | Class C | HBsAg tests, rubella, PSA testing, glucose self-test |
| Annex II List A | Class D | HIV, HCV, HBV blood screening; ABO blood grouping |
| Self-testing IVDs | Class C | Home pregnancy tests, blood glucose meters for self-testing |
Classification Rules for IVDs
- Intended Use is Primary — an IVD intended for self-testing is classified higher than the same IVD intended for professional lab use
- Annex Lists are Definitive — if your IVD is listed in Annex II, it is classified at that level regardless of other factors
- Novel IVDs — novel IVDs not fitting existing categories are classified based on risk to individual and public health
IVD-Specific Registration Requirements
In addition to standard device documentation, IVD registrations require:
- Analytical performance data — sensitivity, specificity, precision, accuracy, linearity, interference studies
- Clinical performance data — diagnostic sensitivity and specificity from clinical studies
- Reference measurement procedures — traceability to international reference standards where available
- Stability data — real-time and accelerated stability for shelf life claims
- Quality control information — information on controls supplied with the device
Self-Testing IVDs
IVDs intended for use by laypersons (home use) require additional consideration:
- Instructions for Use must be written for a lay audience
- Usability/human factors studies demonstrating safe use by untrained users
- MDA may require additional clinical evidence demonstrating appropriate performance in self-testing conditions
Malaysia continues to align its IVD framework with IMDRF guidance on IVD regulation. Monitor MDA's website for updated IVD-specific guidance notes.