Risk Management
Framework: ISO 14971
Indonesia's device registration requirements align with ISO 14971 (Medical devices — Application of risk management to medical devices) as the accepted standard for risk management documentation. Your risk management file should follow the ISO 14971 process:
- Risk analysis
- Risk evaluation
- Risk control
- Evaluation of overall residual risk
- Risk management review
- Production and post-production activities
Risk Management File Requirements
The dossier must include at minimum a Risk Analysis and Control Summary — a document that provides an overview of:
| Element | Content |
|---|---|
| Intended use and reasonably foreseeable misuse | Defined in risk analysis |
| Hazard identification | All identified hazards associated with the device |
| Hazard situations and harms | Analysis of hazard sequences leading to harm |
| Severity and probability of harm | Risk estimation per ISO 14971 |
| Risk control measures | Design, protective, and information-for-safety measures |
| Residual risks | Remaining risks after controls, with acceptability determination |
| Risk–benefit analysis | For Class C/D: formal analysis that benefits outweigh residual risks |
| Completeness check | Confirmation that all known device hazards have been addressed |
Class-Specific Requirements
| Class | Risk Management Depth |
|---|---|
| A | Basic risk summary; simpler hazard/harm analysis acceptable |
| B | Full risk analysis per ISO 14971; risk control measures documented |
| C | Full risk management file; residual risk justification; post-market risk monitoring plan |
| D | Full risk management file; formal risk–benefit analysis mandatory; traceability to FSCA plan; PSUR commitment for ongoing risk review |
Common Evaluator Queries on Risk Management
Kemenkes evaluators frequently raise clarification queries on:
- Insufficient hazard coverage — evaluators may note that specific foreseeable misuse scenarios have not been addressed
- Residual risk acceptability — the basis for accepting a residual risk must be documented; "no incidents reported to date" is generally insufficient
- Risk control effectiveness — evidence that risk control measures actually reduce risk as claimed
ISO 14971:2019 vs Earlier Versions
Indonesia does not mandate a specific edition of ISO 14971, but the 2019 revision is the current applicable standard. If your existing risk management documentation was prepared to ISO 14971:2007, a gap assessment and update to 2019 requirements may be needed before submission.
This line appears orphaned at the end of the Risk Management section. It should be removed or integrated as clarification text within the Class A row of the Class-Specific Requirements table.