Class D Medical Device Registration in Indonesia: Timelines, Deficiency Rounds and Local Verification

1. Key takeaways

Class D is the highest-risk tier of the Indonesian classification system and carries the longest official assessment clock of the four classes: a maximum of 55 working days for a new registration. The fee level is correspondingly the highest, and the deficiency mechanism differs from the lower classes in one respect, a longer response window per round, while remaining identical in another respect, the total of two rounds. What most distinguishes Class D projects in practice, however, is not the official clock but the possibility of local clinical verification for innovative high-value devices, and the sheer weight of the dossier. Planning that treats the 55-working-day figure as the project duration is planning that will fail, because the clock covers only the assessment segment and leaves every preparatory and corrective step outside its count.

• Official assessment clock for a new Class D registration: up to 55 working days, the longest of the four classes.
• PNBP fee of approximately IDR 5,000,000 for a new registration; renewal or variation approximately IDR 1,000,000, as reference values.
• Deficiency response window: 15 working days per round for Class D, versus 10 working days per round for Classes A to C, with a maximum of two rounds in both cases.
• Local clinical verification may be required for innovative high-value devices with no domestic equivalent; imported AI products for diagnosis, screening or clinical decision-making must complete local clinical verification under KMK 951/2026.
• Class D renewal requires a PMS report, with data completeness and traceability especially critical for implantable and life-support products.
• End-to-end duration in industry practice is approximately 5-7 months, a practical estimate rather than an official figure.

2. Legal basis

The procedural framework for Class D is anchored in Annex 3 of Permenkes No. 11/2025, which fixes the maximum assessment duration for a new Class D registration at 55 working days and sets the deficiency response window at 15 working days per round, against 10 working days per round for Classes A to C. Both regimes share the same ceiling of a maximum of two deficiency rounds. The longer window for Class D reflects the technical complexity of high-risk submissions, but the consequence of exhausting the rounds is the same: a second deficiency round that is not resolved can lead to a rejection notice. The PNBP fee for a new Class D registration is approximately IDR 5,000,000, with renewal and variation at approximately IDR 1,000,000, as reference values confirmed against the actual Regalkes invoice. Local clinical verification obligations for AI and software products are specified in KMK No. HK.01.07/MENKES/951/2026, which clarifies that imported AI products used for diagnosis, screening or clinical decision-making must complete local clinical verification in Indonesia and submit the results within one year after obtaining the certificate. Together these provisions place Class D projects on a longer, more evidence-intensive footing than any other class, which is why the practical estimate for the full journey runs in months rather than weeks.

3. Expert insights

The deficiency mechanism deserves precise reading. Classes A to C receive 10 working days per deficiency round; Class D receives 15 working days per round. Both regimes allow a maximum of two rounds, and a second round that fails to satisfy the assessor can end in rejection. The wider window for Class D is reasonable given the depth of technical review, but it is a longer window, not a larger allowance: the total number of opportunities to fix the file is the same two rounds, which places a premium on first-pass completeness. On local verification, the trigger condition is the combination of innovation and the absence of a domestic equivalent: for innovative high-value devices where no comparable product exists in Indonesia, Kemenkes may require clinical verification on the Indonesian population. KMK 951/2026 sharpens this for artificial intelligence: imported AI products used for diagnosis, screening or clinical decision-making must complete local clinical verification in Indonesia and submit the results within one year after certification. Renewal mirrors Class C in requiring a PMS report, and for implantable and life-support products the completeness and traceability of post-market data are especially consequential, because these are the product categories where a gap in the record has the most serious implications. The end-to-end reality is that the official 55-working-day clock coexists with dossier depth, possible local testing or verification, and two potential deficiency round-trips, producing an industry experience value of approximately 5-7 months, a practical estimate and not an official commitment.

4. Practical recommendations

• Do not back-schedule the market launch from the 55-working-day official clock; use an end-to-end baseline of approximately 6 months and then add uncertainty for local verification and testing.
• Give the sales function a conservative commitment date, so that goods arriving at port without a certificate do not sit in storage and incur substantial warehousing charges.
• Aim for first-pass completeness in the dossier, because the deficiency allowance is two rounds in total even though each Class D round allows 15 working days.
• Determine early whether the product may trigger local clinical verification, in particular for innovative high-value devices without a domestic equivalent.
• For imported AI products used for diagnosis, screening or clinical decision-making, plan the local clinical verification and the submission of results within one year after certification as required by KMK 951/2026.
• Start PMS data accumulation on the day of certification, with emphasis on completeness and traceability for implantable and life-support products ahead of the renewal-stage PMS report.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3: 55 working days for Class D new registrations, 15 working days per deficiency round.
• □ PNBP fee rates: IDR 5,000,000 for a new Class D registration, as reference values.
• □ KMK No. HK.01.07/MENKES/951/2026 on local verification for AI and software products.
• □ End-to-end duration figures are industry experience values, marked as a practical estimate.
• □ Data verified as of October 26, 2026, pending verification against current official sources at the time of submission.

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