GRZAN Services in Indonesia: The Independent Licence Holder Model

1. Key takeaways

The hardest problem Chinese manufacturers face in Indonesia is the licence holder. Indonesia does not allow foreign manufacturers to hold the certificate directly: the rights holder of the certificate must be an Indonesian local company holding an IDAK. Handing the licence to a distributor means handing legal ownership of the certificate to a channel partner; once the cooperation changes, what the manufacturer faces is not a change of agent but re-registration plus a supply cut-off.

• The GRZAN solution is the independent licence holder model. GRZAN’s own Indonesian subsidiary, PT. GRZAN GRUP INDONESIA, holds the AKL certificates as licence holder, decoupling legal licensing from commercial distribution. The manufacturer can therefore: retain the initiative to adjust channels, avoid lock-in to a single distributor, and flexibly arrange multiple distribution partners under the same compliant SKU.
• Local capability can be verified through three checkable facts. ① Entity and qualifications — a self-operated Indonesian subsidiary holding IDAK distribution qualification and a CDAKB certificate; ② an actual licence-holding record — as of the October 2026 check, the entity holds 58 AKL certificates under Kemenkes, all with Active status, verifiable by entity name in the Kemenkes public database; ③ a local team — Indonesian-language document review, review communication, customs clearance and post-market reporting are executed locally, without reliance on subcontracting.
• Services cover six stages. ① Feasibility assessment (classification determination, pathway planning, time and cost estimation); ② licence-holding scheme design (comparison of the three schemes — independent licence holder / subsidiary / distributor — and LoA clause design); ③ document preparation (CSDT writing, notarisation/apostille of the LoA and CFS, ISO 13485 check, Indonesian-language labels and instructions for use); ④ submission and deficiency response (OSS/Regalkes submission, PNBP payment, up to two deficiency response rounds); ⑤ market access (KFA code, e-Katalog listing, TKDN strategy and localisation path); ⑥ post-market maintenance (e-report distribution reports, vigilance and FSCA, renewal and change merged submissions).
• Additional specialist capabilities. ① Import and customs clearance — SAS (the unregistered emergency channel), sample/material/spare parts import explanation letters, per-shipment SKI; ② halal compliance — ingredient traceability table, dual-path evaluation of certification versus non-halal labelling; ③ AI/SaMD — classification communication under KMK 951/2026 and local clinical validation scheduling; ④ local testing coordination — TTI screening validation and designated laboratory liaison.

2. Legal basis

The licence-holder rules that make the model necessary come from Permenkes 11/2025, Standards 3 and 6, which govern licence holder qualification; the consequences of an authorisation ending come from Permenkes 5/2026, Article 51 paragraph 1 point d. Because foreign manufacturers cannot hold the certificate directly, the rights holder must be an Indonesian local company with IDAK, and terminating an authorisation carries real consequences — which is exactly why handing licence ownership to a distributor creates exit risk. The verification record rests on the Kemenkes public query database: as of the check in October 2026, PT. GRZAN GRUP INDONESIA held 58 AKL certificates with Active status, searchable by entity name. The services described on this page are subject to the actual contract terms agreed with each client, and the six-stage service structure and specialist capabilities are delivered against those contractual arrangements rather than as statutory entitlements.

3. Expert insights

The licence holder decision is a control decision, not a logistics decision. When the certificate sits in a distributor’s name, the manufacturer’s entire market position rests on the health of that one relationship. Renewals, label changes, downstream distribution approvals and enforcement responses all run through the certificate owner. If the relationship ends, the product does not continue under new management — it exits the market until a new licence is granted, because the legal rights holder was never the manufacturer. The independent licence holder model exists precisely to keep the certificate, and therefore the market access, in a legal entity aligned with the manufacturer’s interests while commercial distribution stays flexible.

Verification beats promises. The strongest evidence of a service provider’s capability is checkable in public records: an entity name entered into the Kemenkes public database returns the certificates it actually holds. A record of 58 AKL certificates under Active status, checked in October 2026, says more than any capability presentation, because certificates are granted by the regulator and cannot be self-declared. The other two verification points — that the subsidiary is self-operated rather than a front, and that the local team executes the work itself rather than subcontracting it — determine whether quality and accountability stay with the provider you contracted.

Start with an assessment, not a contract. Providing a product list and intended uses and receiving a feasibility assessment — classification determination, pathway, timeline and budget range, risk list — tells a manufacturer whether the project is worth doing and at what rhythm. This costs little and reorders decisions correctly: the go/no-go judgment comes before any commercial commitment, which is more valuable than a quotation received before anyone has established whether the pathway is viable.

4. Practical recommendations

• Keep licence ownership and distribution separate. Choose an independent licence holder so that channel changes never put the certificate, and therefore market access, at risk.
• Verify any service provider in the Kemenkes public database. Search the entity name, count the AKL certificates, check the status, and treat the result as the primary capability evidence.
• Ask three questions before signing. ① Is the licence-holding entity your own company or subcontracted? ② Can your certificates be found in the Kemenkes public database? ③ Who completes deficiency responses, and within what time? These three answers predict project success better than a quotation.
• Request the feasibility assessment first. Provide the product list and intended uses and obtain classification, pathway, timeline, budget range and risk list before committing to any contract.
• Match specialist needs to the product type. Import channels (SAS, import explanation letters, per-shipment SKI) for equipment, halal dual-path evaluation for consumables, and KMK 951/2026 classification communication plus local clinical validation scheduling for AI/SaMD products.

5. Verification checklist

• □ PT. GRZAN GRUP INDONESIA IDAK qualification and AKL licence record checked in the Kemenkes public query database, check date October 2026
• □ Permenkes 11/2025, Standards 3 and 6 confirmed: licence holder qualification
• □ Permenkes 5/2026, Article 51 paragraph 1 point d confirmed: consequences of authorisation termination
• □ Services on this page subject to actual contract terms
• □ Feasibility assessment requested before any commercial commitment

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