Indonesia Medical Device Review Timelines under Permenkes No. 11/2025

1. Key takeaways

The current review timelines for medical device registrations in Indonesia are set by Permenkes No. 11/2025, issued on October 3, 2025, with the maximum service durations in Annex 3 expressed in working days. The framework applies across all submission types: new registrations by risk class, renewals, variations, combined renewal with variation, and notification-list products. Compared with the previous framework of the Permenkes 62/2017 era, every clock has been extended, but the deficiency mechanism has been made more forgiving, moving from a single deficiency round to two. Reading the two changes together gives the correct picture: assessment takes longer, but the process tolerates more correction. Enterprises should also understand what the official clock does not cover, and plan the project on a second, longer clock of their own. The distinction between the two clocks is the single most common source of misaligned expectations between regulatory teams and commercial leadership, because a figure quoted in working days is routinely mistaken for a delivery date.

• New registration clocks under Permenkes No. 11/2025 Annex 3: Class A 21, Class B 36, Class C 36, Class D 55 working days.
• Renewal 13 working days; variation 16 working days; renewal with variation 16 working days; notification-type products 12 working days.
• The old framework of the Permenkes 62/2017 era allowed only one deficiency round; the new framework allows two, with 10 working days per round for Classes A-C and 15 for Class D.
• Article 37 of Permenkes 11/2025 leaves implementation arrangements, and the Regalkes platform has not fully synchronised its displayed time limits.
• Expedited review may apply to priority or public-health-related products; there is no public mechanism that accelerates review for a fee.
• Plan every commitment on an end-to-end project clock, never on the official assessment clock alone.

2. Legal basis

The operative provision is Annex 3 of Permenkes No. 11/2025 (October 3, 2025), which fixes the maximum service durations for imported device registrations in working days as follows.

The comparison baseline is the old framework of the Permenkes 62/2017 era, under which notification-type Class A products were served in 7 days, new registrations ran at 15 days for Class A and 30 days each for Classes B and C and 45 days for Class D, renewal took 7 days and variation 10 days, and only one deficiency round was permitted, of 10 days for Classes A-C and 15 days for Class D. The new framework doubles the deficiency allowance to two rounds, at 10 working days per round for Classes A-C and 15 working days per round for Class D. In other words, assessment time has lengthened across every submission type, while the tolerance for correcting a deficient file has widened; the net effect on planning depends on which of the two dominates for a given product. Article 37 of Permenkes 11/2025 retains implementation arrangements for the transition, and industry feedback indicates that the Regalkes platform has not fully synchronised the time limits it displays. The practical stance is therefore to schedule according to the new rules, taking the stricter reading, while deferring to the current standards shown by the system and to official circulars.

3. Expert insights

Three scheduling consequences follow from the new framework. First, the official clock is not the end-to-end period. The clock covers only the assessment segment, while licence holder qualifications, document legalisation, translation and local testing all sit outside it, and each of them can consume more calendar time than the assessment itself. Second, deficiency responses must be fast. The deficiency window is limited, and the technical response team needs to remain available throughout the assessment period rather than disengaging after submission. Third, the lead time for renewals has grown. A renewal clock of 13 working days looks short, but the preparatory work in front of it, the e-report distribution reports and the PMS reports, takes real time to assemble, and the renewal cannot be filed without them. On acceleration, the text of the new regulation notes that review may be expedited for priority products or products related to public health. In addition, approvals from reference jurisdictions such as CE or FDA can reduce the volume of supplementary data requested, which indirectly shortens the actual duration. What does not exist is any public mechanism in which paying an expedite fee buys speed; any suggestion to that effect is not supported by the regulation.

4. Practical recommendations

• Maintain a dual-clock table: one column for the official assessment clock of 21, 36, 36 and 55 working days by class, and one column for the end-to-end project clock including preparatory work and deficiency round-trips.
• Use the second column, the end-to-end clock, for any commitment made to management, and use the first column, the official clock, for process performance measurement of the registration team.
• Schedule to the new rules under the stricter reading, while tracking the current display standards of the Regalkes system and any official circulars that adjust them.
• Keep the technical response team staffed and available for the whole assessment period, so that deficiency notices can be answered within the limited window.
• Start renewal preparations, including e-report distribution reports and PMS reports, well ahead of the 13-working-day renewal clock.
• Do not budget for or rely on any paid acceleration mechanism; the only recognised accelerants are priority or public-health-related status and reference-country approvals that reduce supplementary data requests.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3 timeline table and Article 37 implementation arrangements.
• □ Old framework service standards of the Permenkes 62/2017 era, retained as the comparison reference.
• □ Current displayed standards of the Regalkes system.
• □ The acceleration mechanism is an industry observation, pending verification against official circulars.
• □ Data verified as of October 26, 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