PMS Overview
Post-market surveillance obligations for medical devices in Indonesia — ongoing requirements after NIE issuance, the sanctions regime, and the LAR's responsibilities.
Adverse Event Reporting
How to report medical device adverse events to Kemenkes in Indonesia — reporting timelines, mechanisms, root cause analysis requirements, and follow-up obligations.
NIE Renewal
How to renew a medical device NIE in Indonesia before the 5-year expiry — required documents, process, and managing LoA alignment at renewal.
Change Notifications
How to manage changes to a registered medical device in Indonesia — the distinction between minor change notifications (Perubahan) and changes requiring full re-registration.
Field Safety Corrective Actions (FSCA)
FSCA obligations for medical devices in Indonesia — notification to Kemenkes, Bahasa Indonesia safety notices, mandatory recall procedures, and traceability requirements.
CDAKB Inspections
Kemenkes CDAKB Good Distribution Practice inspections — what is assessed, inspection types, frequency, consequences of failure, and preparation checklist.