Indonesia Regulatory Updates 2023-2026: Timeline and Key Changes for Companies

1. Key takeaways

Over the past two years Indonesia has executed a complete track change in medical device regulation. The timeline below is the single most useful artefact for any company operating in this market.

• The three changes that matter most to companies. ① Permenkes 62/2017 has been repealed — every piece of material that answered to it (including many Chinese-language articles in circulation) is now outdated; ② review timelines have lengthened overall — deficiency response rounds have increased to two, adding tolerance but also time; ③ CDAKB is a hard precondition — without the certificate there is no new product registration and no bidding.
• Operational-level changes also demand attention. Regalkes is now fully electronic and integrated through INSW; entity information and email addresses must be consistent across KFA, OSS and Regalkes. Industry reports indicate that Regalkes was shut down for an upgrade from 15 December 2025 to 9 January 2026, and NIEs expiring during that period were deemed invalid from 1 January 2026 — system downtime is no excuse. (This shutdown information is industry reporting; official announcements prevail.)

2. Legal basis

The instruments on the timeline are the operative legal layer: UU 17/2023 (Health Law, device definition including software, Article 143 business licence obligation); PP 28/2024 of 26 July 2024, which replaced about 31 old government/presidential regulations; Permenkes 11/2025 of 3 October 2025, with 40 articles, 1 appendix and the reset review timelines of 21/36/55 working days; Permenkes 5/2026, signed 17 April 2026 and effective 4 May 2026, whose Article 125 repealed Permenkes 62/2017 and consolidated 40 regulations dating back to 1972; KMK 951/2026 of 7 September 2026, the first guidance for software-based devices with local clinical validation for imported AI products; PP 40/2026 of 14 October 2026 (LN 2026 No.156), deferring the Class A halal obligations to 18 October 2028; and KBLI 2025, switched in OSS on 16 June 2026, moving device wholesale from code 46691 to 46791. Supporting instruments include circular FR.03.01/E/884/2024, which made the CDAKB certificate a precondition for marketing authorisation applications from 1 July 2024.

3. Expert insights

The repeal of Permenkes 62/2017 is an information problem as much as a legal one. Because the old regulation governed registration practice for years, an enormous body of guidance, templates and articles — including much Chinese-language content still circulating — answers to a repealed instrument. Companies that keep using such material are not merely behind; they are systematically wrong about timelines, document sets and procedures. The first action after the 4 May 2026 effective date was therefore not a filing but an audit: every internal SOP, checklist and template referencing Permenkes 62/2017 needed re-basing on Permenkes 5/2026.

The procedural changes trade tolerance for time. Permenkes 11/2025 lengthened the review timelines overall and increased deficiency response rounds to two. Two rounds mean a project can survive two imperfect submissions instead of one — genuine added tolerance — but each round consumes calendar time, so a project that relies on the second round finishes later than the old system would have allowed. Planning should therefore aim to consume zero deficiency rounds, treating the allowance as insurance rather than budget.

Operational consistency across systems is now a compliance requirement in itself. Entity information and email addresses must match across KFA, OSS and Regalkes, and the integrated INSW channel means filings flow through connected systems rather than isolated ones. The reported Regalkes shutdown from 15 December 2025 to 9 January 2026 — with NIEs expiring in the window deemed invalid from 1 January 2026 — illustrates the operational lesson: a system outage does not pause the legal clock. Companies that manage certificate expiries against system availability, rather than against the calendar alone, were the ones that kept their licences. (The shutdown information is industry reporting; official announcements prevail.)

4. Practical recommendations

• Save this timeline as the front page of your regulatory ledger and re-check it quarterly. In a track-change period, the timeliness of information is itself competitiveness: aligning with the new rules three months earlier than peers saves a deficiency round.
• Re-base all materials on Permenkes 5/2026. Audit every SOP, template and article that answers to the repealed Permenkes 62/2017 and rewrite it against the current instrument.
• Track four items going forward. ① The technical guidelines under Permenkes 5/2026 (classification details, marketing authorisation details); ② the actual implementation of Permenkes 11/2025 in Regalkes (Article 37 leaves implementation arrangements); ③ BPJPH follow-up rules on halal-specific categories and PP 40/2026; ④ the KBLI and OSS code update windows.
• Enforce consistency across KFA, OSS and Regalkes. Keep entity information and email addresses identical in all three systems to prevent avoidable rejections.
• Manage certificate expiries against the calendar, not against system availability. Assume the filing system can go down at any time and keep renewal margins that absorb an outage.

5. Verification checklist

• □ UU 17/2023 confirmed: Health Law, software in device definition, Article 143 (verified 26 October 2026)
• □ PP 28/2024 confirmed: 26 July 2024, replaced about 31 old regulations
• □ Permenkes 11/2025 confirmed: 3 October 2025, review timelines A 21 / B·C 36 / D 55 working days
• □ Permenkes 5/2026 confirmed: signed 17 April 2026, effective 4 May 2026, Article 125 repealed Permenkes 62/2017
• □ KMK 951/2026 confirmed: 7 September 2026, software-based device guidance, local clinical validation for imported AI products
• □ PP 40/2026 confirmed: 14 October 2026, LN 2026 No.156; Class A halal obligations deferred to 18 October 2028
• □ KBLI 2025 switch confirmed: 16 June 2026, device wholesale 46691 → 46791
• □ Regalkes shutdown flagged as industry reporting, subject to official announcements

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