Classification
Classification of Medical Device
(According to ASEAN Medical Device Directive)
Medical devices shall be classified into the following four classes, in accordance with risk classification rules. (Risk Classification Rules for Medical Devices other than IVD Devices) and (Risk Classification Rules for IVD Devices):
| Class | Risk Level |
|---|---|
| A | Low Risk |
| B | Low-moderate Risk |
| C | Moderate-high Risk |
| D | High Risk |