INDONESIA · MEDICAL DEVICES

Indonesia AKL Registration: Aligning the Authorisation Letter, Certificates and Models

When preparing an Indonesian marketing authorisation for an imported medical device (AKL), settle three things first: who holds the licence in Indonesia, which products the authorisation covers, and whether the certificates and technical documents cover the same set of models. Putting the CE certificate, ISO 13485 certificate and CFS in one folder can still leave mismatches in legal entity or scope. This article sets out a document-alignment method for foreign manufacturers and their local applicant to check together before submission; for the overall market-entry picture, see Indonesia medical device registration.

Start with the regulatory version. Permenkes 5/2026 on Health Supplies (Perbekalan Kesehatan), signed on 17 April 2026 and promulgated on 4 May 2026, revoked, by its Article 125, Permenkes 62/2017 (the izin edar regulation) and Permenkes 1191/2010 (the former distributor regulation). Article 124 keeps existing implementing rules in force to the extent they do not conflict with it. The product documentation requirements for imported devices now sit in the annex standards of Permenkes 11/2025, issued under PP 28/2025. Old checklists help locate historical files, but current requirements should be taken from the current texts and the live system. (Sources: JDIH status page for Permenkes 5/2026; Permenkes 11/2025)

Separate the product licence from the local company’s qualifications

The Ministry of Health FAQ explains that a medical device izin edar number has 11 digits, prefixed AKD for domestic products and AKL for imported products, and that applications are processed through the regalkes system. (Source: Ditjen Farmalkes FAQ) Article 50(1) of Permenkes 5/2026 provides that health supplies may be marketed only after obtaining an izin edar; Article 57(2) allows imports by business actors holding a business licence (perizinan berusaha), as well as by research institutions, the public or other institutions in accordance with the law, so for the routine commercial imports discussed here the importer should be a business actor with the relevant licence; Article 57(4) provides that medical devices may be imported only after obtaining an izin edar, with an import certificate from the Minister in certain circumstances (Article 57(5)); and Article 40(4) describes distributors’ supply as domestic procurement and importation. (Source: Permenkes 5/2026, pp. 17, 20, 23)

The product licence (AKL) and the local company’s qualifications are therefore two different permits. The annex to PP 28/2025 lists “medical device distributor” (KBLI 46691) as a medium-high-risk activity requiring an NIB and a licence. Its obligations include holding a medical device CDB certificate, distributing only products with an izin edar, filing an e-report every six months, and reporting adverse events, recalls and counterfeit devices. The same entry lists the “import medical device izin edar” (Izin Edar Alat Kesehatan Impor) among the related permits. (Source: PP 28/2025, Annex I.J, pp. I.J.28–I.J.32)

Terms such as PAK and IPAK, common in older documents, come from the revoked 1191/2010 framework; the former CDAKB regulation, Permenkes 4/2014, was also revoked except for its Article 2 and annex. A local company that already has an account or company registration has not thereby shown that its scope of activity, CDB certification and product categories are all in order. The import device standard in Permenkes 11/2025 requires the distributor business licence (PB Distributor Alat Kesehatan) and the CDB certificate to be uploaded; if the product is repackaged in Indonesia and the primary packaging step affects sterility, stability or performance, a CPB (good manufacturing practice for medical devices) certificate is also required. (Sources: JDIH revocation list for Permenkes 5/2026; Permenkes 11/2025, annex)

Use one scope table to link the authorisation and the technical file

The following is a project-preparation method suggested by MediPass, not a form prescribed by the authority.

The statutory list is the import device standard in the annex to Permenkes 11/2025. It includes the application and declaration of authenticity, a product overview, quality system documents, the agent appointment document, a valid marketing authorisation and/or CFS from the country of origin, the manufacturer’s declaration of conformity, and, where applicable, materials, packaging, manufacturing process, performance, risk, clinical, stability and test data. (Source: Permenkes 11/2025, annex import device standard, pp. 401–404) Decide item by item whether each applies and keep the reasoning.

Make the authorisation traceable to the local holder arrangement

First confirm who issues the authorisation: the actual manufacturer, the product owner, or an entity entitled to act for them. Where these differ, the legal relationship needs documentary support. The appointment document should match the products in this application and the local holder; a long-term letter of intent, purchase order or distributor business card is no substitute for the authorisation the registration needs.

Before submission, we suggest checking:

• Signatory: position and signing authority.
• Appointed party: the local holder’s legal name and address match its licence documents.
• Product list: matches the models and product codes applied for, rather than “all products”.
• Term and scope: duration, territory, and activities such as distribution and/or import.
• Term and legalisation: for changes and renewals, the current standard expressly requires the letter of authorisation to state the term of the appointment and to be legalised by the Indonesian mission in the country of origin or apostilled; the new-registration list refers only to the agent appointment document, so confirm the required form against the system before filing. Do not assume Indonesia accepts a scan because another market does. (Source: Permenkes 11/2025 annex, pp. 406–407)

The authorisation directly affects whether the licence survives. Under Article 51(1) of Permenkes 5/2026, an izin edar may be revoked where the manufacturer ends its appointment of the distributor and/or importer (point d), or where the holder’s business licence is revoked or no longer valid (point c). (Source: Permenkes 5/2026, p. 20) If the product already has a holder in Indonesia, also check the existing licence, the authorisation and the exit arrangements; a new application, continuing the existing licence and changing the holder are different operations. See changing the licence-holding distributor in Indonesia.

How a series name on a certificate connects to specific models

Certificate annexes are where gaps are most often missed. A CFS, foreign approval or quality certificate may name only a product series, a performance report may name one model, and the Indonesian application form uses product codes. Build a “sales model – certificate name – tested model – label version” mapping table, with verifiable evidence for each line.

Whether models in one series can be filed together depends first on Indonesia’s grouping rules; even where grouping applies, each model still needs supporting documents. The import device standard in Permenkes 11/2025 allows several products to be registered as one package or group, and requires a list of accessories, sizes, variants, types or product codes with the manufacturer’s supporting data; that list becomes an attachment to the izin edar. State the models for sale and the applicable accessories clearly in the dossier. (Source: Permenkes 11/2025, annex import device standard, pp. 401 and 403)

OEM projects also need to explain the brand owner, the manufacturer and the contract relationship. For imported OEM devices, or devices whose brand is not shown on the CFS, the standard lists trademark certificate or trademark registration documents, and an izin edar for an imported OEM device can in principle be renewed only once and cannot be re-registered under the same brand and type (unless the technology cannot yet be adopted by domestic manufacturers, after review by a team formed by the Minister). (Source: Permenkes 11/2025, annex import device standard, pp. 402 and 407) “Made in the same factory” does not by itself show that two brands can share one set of legal documents.

Illustrative scenario: three sizes do not automatically share the same evidence

Suppose a product is to be filed in sizes S, M and L. The CFS from the country of origin lists only the series name, performance testing covers the middle size, and the smallest size uses different primary packaging. This is an illustration of the method, not an actual approved case.

The manufacturer provides the link between the CFS and the three sizes, the representativeness rationale and the packaging assessment; a single line saying “same series, same performance” is not enough. The local applicant checks whether the three sizes can go into one application and that the authorisation scope matches the scope for sale. Finish this before upload rather than searching for source evidence after a deficiency letter arrives.

Software and IVD products have their own requirements

Software-based devices are prepared under KMK HK.01.07/MENKES/951/2026 (7 September 2026), which covers SaMD, SiMD and AI-enabled devices. The guideline requires local clinical validation in Indonesia for certain imported software devices: those further developed or retrained with data representing the Indonesian population, and those using medium- to high-risk AI technology. Local validation may run in parallel with the izin edar application, and the results must be submitted within one year of the izin edar being issued. (Source: KMK 951/2026, pp. 22–23) These triggers apply only to such software products and should not be read across to all imported devices. For software specifics, see the Indonesia SaMD and AI medical device guideline.

For IVDs, we suggest checking specimen type, analyte, performance data and any applicable quality testing separately, and making sure every reagent, calibrator and control has its own line in the mapping table.

How to run the final check before submission

The following sequence is a MediPass project-management suggestion:

• Round 1, product scope: confirm the imported models, accessories, packaging, brands and sales versions.
• Round 2, evidence: for each applicable document, record the document number, validity, issuer, coverage and gaps.
• Round 3, local submission set: check each item against the system form for legibility and translation, and keep a copy of the final submission.