Medical Device Licence Renewal in Indonesia: Validity, Windows and Prerequisites

1. Key takeaways

The validity of an Indonesian medical device registration certificate is a maximum of 5 years, but the headline number conceals a set of linkage rules that determine the certificate’s real lifespan. Where the licence holder is an authorised distributor or importer, the certificate validity follows the validity of the Letter of Authorisation (LoA), and the authorisation term itself must sit between 2 and 5 years; an authorisation without a stated term or exceeding 5 years results in the certificate being counted as 5 years. OEM-produced products carry a marketing authorisation of no more than 3 years, and the marketing authorisation for imported OEM products can be renewed only once. The renewal window opens within 9 months before expiry, the official renewal clock runs 13 working days, and the renewal must be preceded by a hard prerequisite: the licence holder’s report submission through the e-report system. Taken together, these rules make renewal less a formality than a test of whether the licence holder’s document management has kept pace with the certificate over its full term.

• Certificate validity is a maximum of 5 years; for authorised distributor or importer licence holders, validity follows the LoA.
• The LoA term must be between 2 and 5 years; without a term or beyond 5 years, the certificate counts as 5 years.
• OEM products: marketing authorisation up to 3 years, with imported OEM products renewable only once.
• Renewal applications may be filed within 9 months before expiry; the official clock is 13 working days, or 16 working days for renewal with variation.
• A production or distribution/import report through the e-report system is a hard precondition for the renewal application.
• Class C and Class D renewals additionally require a post-market surveillance (PMS) report.
• After expiry, the application is treated as new: full process, new application fees, new application queue.

2. Legal basis

The rules on validity, invalidation and renewal derive from Articles 24 to 26 of Permenkes No. 62/2017, which are carried forward in current practice under Permenkes No. 5/2026. On validity, the certificate lasts a maximum of 5 years, with the LoA linkage rules described above: an authorised distributor or importer licence holder’s certificate follows the LoA validity, the authorisation term must be between 2 and 5 years, and an authorisation without a stated term or over 5 years produces a 5-year certificate count. OEM arrangements are treated separately: products produced under OEM mode carry a marketing authorisation of no more than 3 years, and imported OEM products can be renewed only once. The timeline provisions come from Annex 3 of Permenkes No. 11/2025, which sets the renewal clock at 13 working days, renewal with variation at 16 working days, and requires a PMS report for Class C and Class D renewals. The reporting precondition runs through the e-report system at e-report.alkes.kemkes.go.id, where the production or distribution/import report must be submitted before the renewal application can proceed. The PNBP renewal rates are IDR 500,000 for Class A and IDR 1,000,000 for Classes B, C and D, as reference values.

3. Expert insights

The sequencing rule is the first practical insight: the licence holder must first submit the production or distribution/import report through the e-report system, and only then can the renewal application be filed. This is a hard precondition, and missing it blocks the submission outright. The expiry consequence is the second insight. An application filed after expiry is handled as a new application, meaning the full registration process again, fees at the new application rate, and a place in the new application queue. The certificate’s continuity, and with it 5 years of accumulated brand and channel position, cannot be preserved by filing two months late. The third insight concerns the five situations in which a certificate becomes invalid: expiry of the certificate, expiry of the production licence, expiry of the IDAK, expiry of the LoA or its non-renewal, and revocation of the certificate. Of these, the last two, LoA expiry or non-renewal and revocation, are the main sources of non-technical certificate breakage, the failures that have nothing to do with the product and everything to do with document management. A LoA that lapses while the certificate is still nominally valid takes the certificate down with it, which is why the LoA expiry date deserves to be monitored as fiercely as the certificate date itself. For portfolio owners, the aggregate lesson is that certificate continuity in Indonesia is a supply-chain property as much as a regulatory one: it holds only as long as every linked instrument, from the LoA to the IDAK, stays valid alongside it.

4. Practical recommendations

• Combine the renewal with a variation where possible: the combined filing usually carries a lower official fee and saves one round of queueing, provided the variation items are sorted out before the window closes.
• Submit the production or distribution/import report through the e-report system before attempting the renewal application, since it is a hard precondition that blocks submission if missed.
• Prepare the PMS report in good time for Class C and Class D renewals, drawing on post-market data accumulated continuously since certification.
• Set the LoA expiry date as a strong reminder node placed earlier than the certificate expiry date, because a gap in the LoA directly breaks the certificate.
• Track all five invalidation triggers, namely certificate expiry, production licence expiry, IDAK expiry, LoA expiry or non-renewal, and revocation, on a single compliance calendar.
• File the renewal within the 9-month window before expiry, never after, since a late filing means the full new-application process, fees and queue.

5. Verification checklist

• □ Permenkes No. 62/2017 Articles 24-26 on validity, invalidation and renewal, carried forward under Permenkes 5/2026.
• □ Permenkes No. 11/2025 Annex 3: renewal 13 working days, renewal with variation 16 working days, PMS report for Class C and D renewals.
• □ e-report system distribution/import report requirement: e-report.alkes.kemkes.go.id.
• □ PNBP renewal rates: IDR 500,000 for Class A, IDR 1,000,000 for Classes B/C/D, as reference values.
• □ Data verified as of October 26, 2026, pending verification against current official sources.

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