INDONESIA · MEDICAL DEVICES

Indonesia Medical Device Changes: The Four Perubahan Izin Edar Routes

A European manufacturer is two years into its Indonesian izin edar and has four changes queued: a new secondary-packaging supplier, an Indonesian-language IFU, an additional product code for a new model, and the relocation of one production line. The licence-holding distributor (PAK) asks whether this is one filing or several. The manufacturer’s change-control log classifies all four as minor. Indonesian regulation does not.

Indonesia has no single “change notification” route for registered medical devices and IVDs; every change is sorted into one of four paths by its effect on safety, quality and performance — a new izin edar, a perubahan under the existing number, a pemberitahuan to the Director General, or QMS documentation alone — and getting the path wrong means at best a returned file and at worst a lapsed licence number and fresh registration.

Why does Indonesia split “changes” into four routes?

Article 30(1) of Permenkes 62/2017 (revoked by Permenkes 5/2026 in May 2026) confined perubahan izin edar to five categories: size, packaging, labelling (penandaan), accessories or attachments listed on the licence, and the name or address of the representative authorised by the manufacturer. Article 30(2) kept the izin edar number for such changes, and Article 30(3) required other changes to be filed as new applications. The 2021 Pedoman built its classification on this framework and is still used in practice. (Source: Permenkes No. 62/2017, 2017-12-29, Art. 30)

Former Article 31 added a notification route: where a change affects the labelling of all products from a manufacturer and does not affect safety, quality or usefulness, the licence holder submits a pemberitahuan to the Director General. (Source: Permenkes No. 62/2017, 2017-12-29, Art. 31)

The Pedoman Manajemen Perubahan Izin Edar issued by the Directorate General in December 2021 turns these articles into a classification table: changes affecting safety, quality, usefulness or performance go to a new application; those that do not go to perubahan; labelling changes across all products go to notification. The table’s “registration type” column adds a fourth outcome, “documented in the quality management system”, for changes needing no filing. The guideline cites AHWP/WG2-WG1-WG3/F001:2019 as its harmonisation reference. (Source: Pedoman Manajemen Perubahan Izin Edar Alkes dan Alkes IVD, 2021-12-03, §2.2, §2.4)

Which changes require a new izin edar?

Section 2.4.9 of the Pedoman lists seven changes that must be filed as new applications: product name; replacement, transfer or relocation of the distributor; change of manufacturer; change of manufacturing location; change of product specification; raw-material or formula changes that alter specification or function; and changes to claims or indications. In the multiple-change worked example in Section 3, a change of sterilisation method is likewise treated as a new application. (Source: Pedoman Manajemen Perubahan, 2021-12-03, §2.4.9, §3)

The distributor rule follows from how an izin edar is held: Articles 13, 25 and 49 of the former 62/2017 tied the izin edar to the PAK’s exclusive appointment and its term. Under the current Permenkes 5/2026, Article 51(1)(d) makes termination of a distributor’s appointment a ground for revocation. (Source: Permenkes No. 62/2017, 2017-12-29, Arts 13, 25, 49; Permenkes No. 5/2026, 2026-05-04, Art. 51(1)(d)) The full sequence for replacing a licence holder, including stock run-down, is covered in our Indonesia change-of-distributor article.

Which changes stay under the existing number, and which only need a notification?

Section 2.4.8 gives thirteen perubahan examples (a–m): size and fill volume; packaging size, type, design or material; labelling (IFU language, logos or symbols, shelf life, product code or type, storage temperature, name correction, label design); accessories and models; principal name or address; manufacturer legal entity; manufacturer address without relocation; product-owner name or address; distributor name under the same NIB; distributor address; and typographical corrections. For items i, k and l a paper letter with supporting data must first go to the Directorate of Medical Device Assessment to update the e-regalkes company database. (Source: Pedoman Manajemen Perubahan, 2021-12-03, §2.4.8)

The notification route is conditional on the change affecting all products. Changing the IFU language or adding a symbol for a single product remains a perubahan under §2.4.8(c), not a notification. (Source: Pedoman Manajemen Perubahan, 2021-12-03, §2.2, §2.4.8(c))

How are several simultaneous changes classified?

Chapter 3 of the Pedoman deals with multiple changes to one product: each change is classified separately against the tables, the applicant may bundle them into a single submission, and the registration type is “adjusted to the highest type of change made”. The guideline’s example combines a sterilisation-method change (new application), a packaging-layout change (perubahan) and a manufacturer-logo change (notification), and the whole bundle is filed as one new application. (Source: Pedoman Manajemen Perubahan, 2021-12-03, §3)

Applied to the opening case: the packaging-supplier change is QMS documentation if material and specification are unchanged; the IFU language and product code are perubahan; the relocation is a new application. Filed together, the whole package becomes a new application; if the labelling changes must take effect sooner, file them separately.

What do the regulations say about timelines and fees?

Perubahan applications are filed online through regalkes.kemkes.go.id (via INSW/OSS). Articles 33–34 of the former 62/2017 set at most 10 days each for evaluation and issuance, but with that regulation revoked they should no longer be cited as current timelines.

The imported-device izin edar standard in Permenkes 11/2025 (annex p. 409) sets a maximum of 16 days for a change registration, 12 days each for new, renewal and change filings of a notification-type (Notifikasi) izin edar, and 13 days for renewal; at most 2 correction rounds of 10 days each (15 for Class D). An administrative change affecting the labelling of all of a manufacturer’s products requires a pemberitahuan to the Ministry, with no separate processing time. (Source: Permenkes No. 11/2025, Annex, Standard for Imported Medical Device Izin Edar, pp. 406, 409–410)

A comparable official figure is in Annex II of PP 28/2025, which sets processing times for an imported-device izin edar at 21 days (Class A), 36 days (B/C) and 55 days (D) for a new application, 13 days for a renewal and 16 days for “a change or a renewal with change”; domestic devices are 16/26/40 days. (Source: PP No. 28/2025 Annex II – Health Sector, 2025-06-05, Izin Edar Alat Kesehatan Dalam Negeri/Impor)

Fees follow the PNBP bill issued in regalkes. For reference, the Ministry’s Pedoman Penilaian Alat Kesehatan of November 2019 listed, citing PP 64/2019, new-application PNBP of Rp1,500,000 (Class A), Rp3,000,000 (Classes B and C) and Rp5,000,000 (Class D), and renewal fees of Rp500,000 (Class A) and Rp1,000,000 (Classes B, C and D); renewal is available only where the licence data are unchanged. We could not verify a separate perubahan tariff in an official document and do not state one. (Source: Pedoman Penilaian Alat Kesehatan Sesuai Permenkes 62/2017, 2019-11, §2.2.B, §2.3.B)

Which rules apply now that Permenkes 5/2026 is in force?

Permenkes 5/2026 on Perbekalan Kesehatan was signed on 17 April 2026 and promulgated on 4 May 2026, and the Ministry’s legal database lists Permenkes 62/2017 among the regulations it revokes. Article 122 gives the parties concerned up to one year to align with the new regulation, and Article 124 keeps existing implementing provisions in force so far as they do not conflict with it. (Source: JDIH Kemenkes – Permenkes No. 5/2026 status page, 2026-05-04; Permenkes No. 5/2026, 2026-05-04, Arts 122, 124)

Permenkes 62/2017 is therefore no longer current law. In MediPass’s current Indonesian filings, change applications in regalkes still follow the 2021 Pedoman classification and the established workflow. For changes planned in 2026–2027, prepare the file against the Pedoman classification, cite Permenkes 5/2026 and PP 28/2025 as the legal basis, and leave room to adjust once new implementing rules are published.

For scheduling, only the licence-holding PAK can file; the manufacturer cannot submit directly. A hypothetical example: a manufacturer will start production at a new site in the first quarter of 2027 and also needs an Indonesian IFU. The sensible order is to complete the IFU change as a perubahan first, then open the new izin edar application once the new site’s QMS certificate is in hand, checking the expiry dates of the existing licence and letter of appointment so that the switch of licence numbers does not fall out of step with the appointment term.