INDONESIA · MEDICAL DEVICES

Indonesia Post-Market Duties: e-report, e-watch and Izin Edar Renewal

An IVD manufacturer’s Indonesian izin edar has ten months left. The licence-holding distributor (PAK) prepares to renew and finds the e-report distribution filings incomplete. At the same time, head-office vigilance asks about Indonesia’s adverse-event reporting deadline, and the distributor has never filed anything on e-watch. In Indonesia, post-market duties are spread across periodic reporting, adverse events, recall and distributor qualifications, and a gap in any of them affects the licence itself.

Since May 2026 the current basis for Indonesian post-market duties for medical devices (GMD) and IVDs is Permenkes 5/2026 together with PP 28/2025: periodic reports twice a year, adverse events reported within 48 hours, 10 days or 30 days by severity, revocation risk if the appointment ends or the holder’s business licence lapses, and an expired, un-renewed licence as a statutory ground for recall and destruction. The former Permenkes 62/2017 has been revoked.

How are validity and the risk of revocation determined?

The health-sector licence list in Annex II of PP 28/2025 sets izin edar validity at up to 5 years. Article 51(1) of Permenkes 5/2026 allows revocation where the holder’s business licence is revoked or lapses (c) or the manufacturer terminates the appointment (d), so the licence’s real life depends on the appointment and the PAK’s qualifications staying valid, not only on the printed expiry date. (Source: PP No. 28/2025 Lampiran II, 2025-06-05, Izin Edar Alat Kesehatan Impor; Permenkes No. 5/2026, 2026-05-04, Art. 51(1)(c)–(d))

The former Permenkes 62/2017 tied validity to the appointment term and capped OEM products at 3 years. It was revoked by 5/2026 in May 2026; pending new implementing rules, actual validity follows what regalkes issues. (Source: JDIH Kemenkes – Permenkes No. 5/2026 status page, 2026-05-04; Permenkes No. 62/2017, 2017-12-29)

What matters for renewal?

Annex II of PP 28/2025 sets 13 days to process an izin edar renewal and 16 days for “a change or renewal with change”. The Ministry’s 2019 Pedoman Penilaian states that renewal applies only where licence data are unchanged and listed renewal PNBP of Rp500,000 (Class A) and Rp1,000,000 (Classes B, C and D); actual fees follow the regalkes bill. (Source: PP No. 28/2025 Lampiran II, 2025-06-05, Izin Edar Alat Kesehatan Impor; Pedoman Penilaian Alat Kesehatan, 2019-11, §2.3)

The renewal window is now set by the imported-device izin edar standard in Permenkes 11/2025: a renewal application must be filed no later than 9 months before expiry (“paling lambat 9 bulan”), the opposite direction from the former 62/2017 rule of “earliest 9 months before”. Renewal with changes also requires distribution reports to have been filed electronically at least every 6 months before the application, and Class B IVD reagents and Class C/D devices must attach a post-market surveillance report. The former 62/2017 rule refusing renewal after two years of nil reports has no counterpart in 11/2025 and should not be cited as current law, although missing reports can still affect the review. At most 2 rounds of corrections are allowed, 10 days each (15 for Class D). (Source: Permenkes No. 11/2025, Annex, Standard for Imported Medical Device Izin Edar, pp. 406–410)

What do periodic reports cover, and how often?

Annex II of PP 28/2025 lists, among izin edar holder obligations, “periodic reports twice a year” and reporting when adverse events occur. (Source: PP No. 28/2025 Lampiran II, 2025-06-05, Kewajiban Pelaku Usaha)

Permenkes 5/2026 moves reporting into SIK, integrated with the national health information system: Article 96(1) requires holders to report production and/or imports and to report potential shortages at least 6 months ahead; Article 81 requires manufacturers and distributors to report distribution; Article 92 requires destruction to be recorded and reported through SIK. (Source: Permenkes No. 5/2026, 2026-05-04, Arts 81, 92, 96(1))

How are adverse events (KTD) reported?

Holders report KTD through e-watch Alat Kesehatan dan PKRT. The ministerial regulation itself sets no day count, but the Ministry’s 2020 KTD reporting technical guideline (Chapter III.D) sets tiered deadlines: events posing a serious public-health threat or with potentially wide impact within 48 hours; events that caused death or serious injury within 10 days; events that could cause death or serious injury if they recur within 30 days. Chapter III.E requires an initial investigation report within 7 days of learning of the event and a final report with root cause and corrective action within 30 days of the initial report being received. The guideline is Directorate-General level guidance and predates Permenkes 5/2026, but remains the operating basis for e-watch reporting. (Source: Kemenkes, Petunjuk Teknis Pelaporan KTD Alat Kesehatan, 2020, Chapter III.D–E)

Article 103 of Permenkes 5/2026 establishes device vigilance, defined as detecting, assessing, understanding, communicating and controlling adverse events; Article 105(2) leaves technical guidance to the Minister; until new guidance is issued, the 2020 tiers apply. (Source: Permenkes No. 5/2026, 2026-05-04, Arts 103, 105(2))

Who is responsible for recall and destruction?

Article 85(1) of Permenkes 5/2026 places the recall duty on licence holders and business actors; Article 86 lists six grounds for recall, including (e) “the izin edar has expired and not been renewed”; Article 87 requires the recalling party to record and report to the Minister; Article 89(1)(d) likewise makes an expired, un-renewed licence a ground for destruction; Article 91 requires a risk analysis before destruction; Articles 88 and 93 leave recall and destruction procedures to the Minister. Article 117 lists failure to report distribution, recall or destroy as violations, and Article 119 sanctions include written warnings, suspension of distribution or recall orders, and destruction orders. (Source: Permenkes No. 5/2026, 2026-05-04, Arts 85–93, 117, 119)

How do distributor qualifications (CDB) affect the licence?

Under PP 28/2025 the distributor’s Sertifikat Cara Distribusi yang Baik (CDB) untuk Alat Kesehatan is valid for 5 years, requires an annual internal audit report and takes 30 days to process; Article 51(1)(c) of Permenkes 5/2026 allows revocation of the izin edar where the holder’s business licence is revoked or lapses. (Source: PP No. 28/2025 Lampiran II, 2025-06-05, Sertifikat CDB Alat Kesehatan; Permenkes No. 5/2026, 2026-05-04, Art. 51(1)(c))

For planning, keep the Indonesian licence, the letter of appointment and the PAK’s CDB certificate in one expiry table, and ask the distributor for proof of each half-yearly report. Hypothetical example: the licence expires in August 2027 and the appointment in March 2027. Extend the appointment to cover the new licence term first, since an ended appointment can trigger revocation under Article 51; the renewal must be filed no later than 9 months before expiry (by November 2026 in this example), so the appointment extension and any missing reports have to be dealt with before then.