Special Access Route (Exemptions)
Overview
The Special Access Route (SAR) — also referred to as the Special Access Scheme — allows unregistered medical devices to be imported and used in Malaysia in specific circumstances where the public health benefit justifies the use of an unregistered device.
The SAR is an exception, not a route to market entry. Manufacturers should not rely on the SAR as a long-term supply pathway — registration remains the expected route for commercially supplied devices.
When Can the SAR Be Used?
MDA may permit use of an unregistered device under the SAR when:
| Scenario | Description |
|---|---|
| Compassionate use | A patient with a life-threatening condition has no acceptable registered alternative available |
| Emergency / humanitarian | Public health emergency requiring devices not yet registered |
| Clinical investigation | Unregistered device to be used in an authorised clinical investigation |
| Pilot/evaluation | Evaluation of a device by a healthcare facility prior to formal registration (limited scope) |
| Novel device | First-in-kind device for which there is no equivalent registered in Malaysia |
Application Process
SAR applications are submitted to MDA via the MyMDA portal:
- The requesting healthcare facility or clinician (not the manufacturer/LAR) initiates the SAR application
- The manufacturer/LAR provides supporting documentation
- MDA reviews and approves or rejects the application
Required Documentation
| Document | Provided By |
|---|---|
| SAR application form | Healthcare facility / clinician |
| Device description and intended use | Manufacturer / LAR |
| Evidence of registration in home country (CE, FDA, TGA, etc.) | Manufacturer / LAR |
| Clinical evidence / published data | Manufacturer / LAR |
| Justification for use of unregistered device | Healthcare facility / clinician |
| Patient/institutional consent (where applicable) | Healthcare facility |
| Statement that no acceptable registered alternative is available | Healthcare facility |
SAR Approval
If approved, MDA issues an SAR authorisation specifying:
- Device details
- Approved quantity
- Duration of approval
- Specific conditions of use
- Reporting obligations
Obligations Under SAR
SAR-authorised device supply is subject to ongoing obligations:
- Adverse event reporting — must report any adverse events to MDA within the standard MPR timelines
- Quantity tracking — must not exceed the approved quantity
- Use restriction — must be used only as specified in the SAR authorisation
- Follow-up — MDA may require outcome reporting or clinical data from SAR-authorised use
SAR is Not a Registration Pathway
MDA expects manufacturers whose devices are repeatedly used under SAR to pursue full registration. Repeated SAR approvals for the same device may prompt MDA to require the manufacturer to initiate formal registration.
Consider initiating formal registration concurrently with an SAR application for devices expected to have ongoing Malaysian demand. This avoids reliance on a case-by-case approval mechanism.