Expiry or lapse consequence
authorization.lapse
Expired authorization generally requires a new application.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Ministry of Health · structured requirements
🇮🇩 Indonesia medical device regulatory data
Explore the medical device requirements currently available for Indonesia, organized by topic and linked to official sources.
5 facts3 dimensions1 official sourceslatest verification 2026-08-13
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
Official document
Renewal or maintenance
authorization.renewal
Apply from 6 months before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Change-control outcomes
change.available-outcomes
- Outcomes
- Notification Or Administrative Update
- New Registration Or New Application
- Description
Minor changes include limited size/package/label/tax-number events; the guide should be checked against current implementing rules.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
New-application triggers
change.new-application-triggers
- product/manufacturer/distributor changes
- functional specification or formula changes outside minor scope
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Representative or holder change
market-entry.representative-change
- Path Code
New Registration Risk For Distributor Change
- Fresh Registration
Often Yes
- Minimum Handover
- new exclusive LoA
- old authorization termination
- dossier and authorization
- inventory/import records
- complaints/recalls
- Bahasa labels
- Notes
Treat distributor-holder change as a potential new application, not a simple EU-style AR update.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
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