Six Ongoing Post-Market Obligations for Medical Devices in Indonesia

1. Key takeaways

In Indonesia, obtaining the marketing authorisation is the beginning of compliance, not the end of it. A licence holder carries six continuing obligations: ① distribution/import reporting, submitted through the e-report system; ② vigilance and adverse event reporting; ③ field safety corrective actions (FSCA); ④ complaint handling; ⑤ cooperation with routine inspections; and ⑥ post-market surveillance (PMS) reports at licence renewal for Class C and Class D devices.

• e-report is both a daily duty and a renewal gate. The e-report system (e-report.alkes.kemkes.go.id) is the electronic system through which marketing authorisation holders submit production or distribution/import reports. It is not merely a routine obligation: it is a hard precondition for licence renewal. Where reports have not been submitted, the renewal application cannot advance, so a reporting failure quietly resurfaces five years later as a licensing problem.
• PMS is a renewal requirement for Class C and Class D devices (Permenkes 11/2025, Standard 3). At the fifth-year renewal, these two risk classes must present post-market data covering the entire validity period of the certificate. PMS is therefore a continuous record that starts on the day the first licence is issued, not a report assembled shortly before renewal.
• Vigilance is a statutory obligation with sanction exposure. PP 28/2024 expressly requires pharmacovigilance and vigilance to be carried out, and failure to perform them triggers administrative sanctions (Article 408 and related provisions).
• Inspection is risk-based. Routine control covers distribution facilities and products, applied through analytical assessment based on INSW/customs notifications and licensing compliance, or through on-site inspection of distribution facilities and products and targeted inspections.
• One voluntary measure deserves attention. Industry observation indicates that the Ministry of Health encourages an independent post-market test of devices every two years; this is currently voluntary, but performance may in future influence e-Katalog listing priority. (Industry observation, not a mandatory requirement.)

2. Legal basis

The post-market duties rest on two parallel legal tracks, and a compliant company must satisfy both at the same time. The health-law track makes vigilance itself enforceable: PP 28/2024 obliges marketing authorisation holders to run pharmacovigilance and vigilance and attaches administrative sanctions to non-performance, while Permenkes 5/2026 governs post-market surveillance in its Articles 96, 101 and 104. The quality-system track operates through CDAKB: Permenkes 4/2014 requires distributors to establish mechanisms for complaint handling, FSCA, internal audit and management review. This means an auditor can raise a finding under CDAKB even where no adverse event has ever been reported, and Kemenkes can sanction a licence holder under PP 28/2024 even where the quality system is otherwise sound. The e-report system is the operational bridge between the two tracks, because it is the channel through which the reports feeding renewal, surveillance and vigilance are filed.

3. Expert insights

The six obligations are not equal in consequence. Distribution/import reporting looks like the most routine item on the list, yet it is the one obligation whose failure silently blocks renewal. Because the e-report record is a hard precondition for the fifth-year application, an unreported year cannot be patched afterwards; the deficiency is discovered precisely when the company needs its licence extended, leaving no time to fix it calmly. Vigilance and FSCA, by contrast, carry immediate sanction exposure under PP 28/2024, so they are the obligations most likely to generate a regulatory problem during the certificate’s life rather than at its end.

PMS for Class C and D changes how the certificate must be managed from day one. Since the renewal dossier must show post-market data covering the entire validity period, continuity matters more than volume. A gap in the record cannot be reconstructed later from memory or from scattered correspondence; the assessment at renewal will be built on whatever was captured continuously. Companies holding Class C or D approvals should therefore treat the first day after licence issuance as the start of the renewal file, not as a pause after the registration project.

Inspection is designed around risk, not around visiting everyone. The framework relies on analytical assessment driven by INSW/customs notifications and licensing compliance before it resorts to on-site inspection of distribution facilities and products or targeted inspections. In practice this means data quality in the reporting systems directly shapes inspection exposure: an entity whose filings are complete, consistent and current is managed through desk-based analysis, while inconsistencies are precisely the kind of signal that invites a physical inspection. Keeping the electronic record clean is therefore itself an inspection-avoidance measure.

4. Practical recommendations

• Build a one-certificate-one-file post-market ledger. Archive complaints, adverse events, FSCA records, distribution reports and PMS data in five categories, indexed by certificate number, so that the renewal dossier is generated from the archive rather than collected from zero.
• Anchor the ledger to the e-report calendar from the first month after licensing. Treat report submission as a fixed operational step, not as an annual clean-up, because the renewal gate depends on the accumulated record.
• Start PMS recording immediately for Class C and D products. Define what will be captured and store it continuously across the full validity period, so the fifth-year renewal presents a complete dataset instead of a gap-ridden reconstruction.
• Keep CDAKB quality-system records aligned with the statutory vigilance line. Complaint handling, FSCA, internal audit and management review should reference the same events and dates as the regulatory filings, so both tracks tell one consistent story.
• Consider the voluntary biennial independent post-market test. It is not mandatory today, but industry observation links performance to possible future e-Katalog listing priority, and the testing record doubles as documented evidence of product safety.

5. Verification checklist

• □ Permenkes No. 11/2025, Standard 3 confirmed: PMS report required for Class C/D renewal
• □ PP No. 28/2024 confirmed: vigilance obligation and sanction provisions (Article 408)
• □ Permenkes No. 4/2014 confirmed: CDAKB requirements for complaint handling, FSCA, internal audit, management review
• □ e-report system confirmed: e-report.alkes.kemkes.go.id used for production and distribution/import reports
• □ Permenkes No. 5/2026, Articles 96, 101 and 104 confirmed: post-market surveillance provisions
• □ Biennial independent post-market testing noted as industry observation, not mandatory (verified 26 October 2026)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com