Responding to Clarification Requests
What Are Clarifications?
During the technical review phase, Kemenkes evaluators routinely issue clarification requests (permintaan klarifikasi) through the Regalkes portal. These are questions or requests for additional information arising from the evaluator's review of your submitted dossier.
It is standard to expect at least one round of clarification queries for most submissions. Having a clarification request does not mean your application will be rejected — it is a normal part of the review process.
Common Clarification Topics
| Topic | Typical Query |
|---|---|
| Device description | Request for more detail on the mechanism of action, materials, or specific intended use |
| Clinical evidence | Request for additional clinical data or more specific literature references |
| Risk management | Questions about specific hazard scenarios or residual risk justification |
| Labeling | Request to revise label content, strengthen BI language, or add missing elements |
| Technical specifications | Additional test reports or standard compliance evidence |
| Document consistency | Inconsistencies between documents that were not caught in administrative review |
| Manufacturer information | Additional detail on the manufacturing site or production process |
Response Protocol
- Notification: Kemenkes issues the query through Regalkes; the LAR is notified (via the portal and sometimes by email)
- LAR informs manufacturer: The LAR shares the query content with the foreign manufacturer
- Manufacturer prepares response: Draft the response and any additional documents needed
- LAR uploads response: Via Regalkes, within the response time window
- Evaluator reviews response: If satisfactory, review continues; if not, a further round of queries may follow
Response Timeline
Clarification responses are subject to a time limit set by Kemenkes. Failing to respond within the window can result in:
- The query being re-issued
- The application being suspended
- In some cases, the application being returned and requiring full re-submission
Agree upfront with your LAR on a rapid turnaround process for clarification responses. The manufacturer's technical experts (who prepared the original dossier) should be engaged immediately when a query arrives, not after days of internal routing.
Multiple Query Rounds
It is possible to receive two or more rounds of clarification queries before a final decision. Each round resets the review clock for that query. Minimise rounds by:
- Providing complete, well-structured responses with clear references to the dossier
- Submitting revised documents in the correct Regalkes format
- Proactively addressing adjacent questions the evaluator may have
Response Timelines and Deadlines
Clarification responses are typically due within 30 days of the query being issued through Regalkes, though this may be extended to 60 days for complex technical queries or by mutual agreement. Failing to respond within the assigned window can result in:
- The query being re-issued with a shortened timeline
- The application being suspended
- In some cases, the application being returned and requiring full re-submission
Always confirm the exact deadline in the Regalkes portal notification, as it may vary by device complexity or evaluator assessment.