Class A — Low Risk
Definition and Scope
Class A devices are the lowest-risk medical devices under Malaysia's regulatory framework. They are typically:
- Non-invasive and not intended to be introduced into the body
- Used for transient or short-term contact with intact skin
- Non-sterile at point of sale (or sterile where specifically noted)
- Non-measuring in critical applications
Classification Criteria
A device falls into Class A when it:
- Is non-invasive
- Does not contact injured skin or mucous membranes
- Is not intended for direct contact with the cardiovascular or central nervous system
- Does not supply or exchange energy with the body
- Does not store or administer medicines or biological substances
- Is not used to control or monitor a life-sustaining therapy
Class A Examples
| Product | Notes |
|---|---|
| Tongue depressors | Non-invasive, transient contact |
| Elastic bandages | Non-sterile, external use |
| Non-sterile examination gloves | Intact skin contact |
| Stethoscopes | Non-invasive diagnostic |
| Wheelchairs and walking aids | Non-invasive support |
| Hospital beds (non-powered) | Non-active, indirect contact |
| Corrective spectacle frames | Non-invasive |
| Non-invasive thermometers (infrared) | Indirect skin contact |
| Gauze and simple wound dressings | Non-sterile |
Class A Sterile Devices
Class A devices that are supplied in a sterile state (Class A sterile) have additional requirements:
- Must maintain sterility through packaging
- Sterile barrier system must be validated
- Manufacturing of sterile Class A devices requires QMS controls for sterilisation processes
Sterile Class A devices follow the notification route but with additional technical documentation regarding sterility validation. The registration fee remains the same.
Registration: Notification Pathway
Class A devices follow a notification (self-declaration) route:
- Manufacturer/LAR completes self-declaration of conformity to Essential Principles
- Submits notification via MyMDA portal with:
- Device description and intended purpose
- Classification justification
- Self-declaration of conformity
- Label and IFU
- MDA acknowledges the notification
- Device receives a Device Registration Number (DRN)
No independent conformity assessment body review is required for standard Class A devices.
Key Obligations
- Establishment licence required before supply
- Self-declaration must be truthful and supportable by documentation
- Post-market surveillance obligations apply
- Mandatory Problem Reporting (MPR) obligations apply if serious incidents occur
The manufacturer bears full legal responsibility for the accuracy of the self-declaration of conformity. MDA may audit or inspect at any time. Misrepresentation is an offence under Act 737.