Adverse Event Reporting
What Must Be Reported?
Any incident or near-incident involving a medical device that has, or could have, caused serious injury or death to a patient, user, or third party must be reported to Kemenkes. This includes:
- Device malfunction or deterioration in characteristics/performance
- Inadequate labeling, IFU, or promotional material that led or could lead to patient/user harm
- Use error that led to serious harm
- Any event that would have led to a serious incident if not for favourable circumstances or healthcare professional intervention
Reporting Timelines
Indonesia does not currently publish a single fixed reporting timeline (unlike, for example, the EU MDR's 15-day/30-day framework), but the general principle is prompt reporting:
| Incident Type | Expected Reporting Timeframe |
|---|---|
| Death or serious deterioration of health | As soon as possible — treat as immediate; typically within 30 days |
| Near-serious incident | Within 30 days of becoming aware |
| Trend analysis / non-serious | As part of periodic safety updates |
Establish a global vigilance procedure that flags any Indonesian patient/user adverse events to your Indonesian LAR for Kemenkes reporting, and align with the most conservative of your applicable reporting timelines. Proactive reporting is always viewed more favourably than late reporting.
How to Report
Adverse event reports are submitted through the Regalkes portal by the LAR. The report should include:
- Device identification (trade name, NIE number, lot/batch number, model)
- Description of the event
- Patient/user details (anonymised)
- Clinical outcome
- Manufacturer's preliminary assessment
- Corrective actions taken or planned
Root Cause Analysis
For serious incidents, Kemenkes may require:
- A formal root cause analysis (RCA) report
- Evidence of corrective and preventive actions (CAPA)
- Timeline for implementation
- Results of any device testing or investigation
Proactive Safety Communications
If the manufacturer issues a global safety advisory or field safety notice for a device registered in Indonesia, the LAR must:
- Notify Kemenkes promptly
- Provide a translation of the safety notice in Bahasa Indonesia
- Coordinate the field safety corrective action in Indonesia (see FSCA)