Compassionate Use
What Is Compassionate Use?
Compassionate use (also referred to as expanded access or named-patient access) allows patients with serious, life-threatening conditions to access medical devices that have not yet received an NIE in Indonesia, where:
- No registered alternative device is available or appropriate for the patient's condition
- The device has shown promising safety and efficacy in clinical investigations elsewhere
- The patient cannot participate in a clinical trial
Regulatory Framework
Indonesia's compassionate use provisions are based on the Ministry of Health's powers to authorise the use of unregistered products in exceptional individual patient circumstances. Specific requirements are managed on a case-by-case basis through Kemenkes.
Application Requirements
Compassionate use applications typically require:
| Document | Description |
|---|---|
| Clinical justification | Treating physician's statement of medical necessity and lack of alternatives |
| Patient informed consent | Patient's understanding and agreement to use of an unregistered device |
| Device information | Complete device description, available safety and performance data |
| Ethics committee review | Approval or notification to an accredited ethics committee |
| Manufacturer declaration | Manufacturer's confirmation of device quality and willingness to support the use |
| Import permit (SKI) | Per-shipment import authorisation from Kemenkes |
Key Constraints
- Compassionate use is patient-specific and cannot be used as a route to distribute a device to multiple patients or facilities without a NIE
- The treating facility and physician bear significant responsibility for the clinical management of the patient
- Adverse events must be reported to Kemenkes
- Compassionate use does not confer any status toward full NIE registration (unlike, for example, EUA which may be followed by expedited standard registration)