Indonesia Medical Device Market Entry: The Six-Step Registration Pathway

1. Key takeaways

The Indonesian market entry pathway has six steps, and the step most often underestimated is not a technical one: it is the choice of licence holder. The official evaluation clock is fixed and knowable, but most of the real project duration lives outside that clock, in the qualification of the licence holder and the preparation of documents that must be complete before the clock even starts.

• Six steps: first, determine the classification (A/B/C/D, which drives the time limits and fees); second, determine the licence-holding entity (an own Indonesian company, or an appointed local licence holder holding IDAK and CDAKB, with a LoA signed); third, prepare the dossier (ASEAN CSDT structure plus administrative documents: LoA, CFS, ISO 13485); fourth, submit the application (OSS or Regalkes, pay the PNBP); fifth, manage evaluation and deficiency responses (a maximum of two rounds of deficiency corrections); sixth, execute the post-certificate actions (KFA code, e-Katalog, batch-by-batch SKI, post-market reporting).
• The step most often underestimated is the second one. Most companies treat the choice of distributor as a commercial decision, but in Indonesia the licence holder is named on the certificate and is the legal rights holder. Changing the licence holder is not a matter of amending a contract; it requires a fresh application for the marketing authorisation.
• Official evaluation clock: 21 working days for Class A, 36 for Class B, 36 for Class C and 55 for Class D, per Permenkes 11/2025.
• The end-to-end practical duration is significantly longer, because the licence holder’s qualifications and the dossier must be ready before the clock starts, and deficiency rounds interrupt the clock. Industry experience values: approximately 1-2 months for Class A, approximately 3-5 months for Class B/C, and approximately 5-7 months for Class D. These are industry experience values, not official commitments.
• CE or FDA certificates are useful but not a substitute. The mandatory documents are the free sale certificate (CFS) from the country of origin and proof of marketing in the country of origin; CE marking or FDA approval are supplementary evidence that can smooth the evaluation and reduce the supplementary data requests, but they cannot replace any mandatory requirement.
• PNBP payment accompanies the submission step, and the certificate-before-import rule means no shipment may be planned ahead of the grant; sequencing revenue before the certificate is not an option the pathway offers.

2. Legal basis

The procedural backbone of the pathway is Appendix 3 of Permenkes No. 11/2025, which sets the evaluation time limits and the document requirements for each class. Permenkes No. 5/2026, in Articles 50 and 58, establishes that the certificate must be obtained before importation, which is why the sequencing of the pathway matters as a legal matter and not merely as a project management preference. Permenkes No. 14/2021 governs the IDAK distribution licence and CDAKB requirements that define a qualified licence holder, and therefore underpins the second step of the pathway where the licence-holding entity is chosen. The end-to-end durations cited alongside the official clock are industry experience values and are identified as such; only the working-day figures in Permenkes 11/2025 carry regulatory force, and any project plan should keep the two categories of timeline strictly separate so that contractual commitments are not made against non-official numbers.

3. Expert insights

Set the project start at the moment the decision to enter Indonesia is made, not at the moment shipment is being prepared. Three workstreams consume time entirely outside the evaluation clock: the qualification of the licence holder (IDAK plus CDAKB), the notarisation and legalisation of documents, and the Indonesian-language labelling and instructions for use. Because they run in parallel with nothing else on the regulatory critical path, they must be started in parallel and early; started sequentially, they stretch the project by months without any visible cause on the evaluation side. The second-step lesson reinforces this: since a change of licence holder means a fresh application for the marketing authorisation, the licence-holding decision made in step two is effectively irreversible at acceptable cost, and deserves the same scrutiny as the technical content of the dossier itself. A structured comparison of licence holder candidates, covering distribution capability, regulatory track record and the validity status of their IDAK and CDAKB credentials, costs little at step two and prevents the disproportionate expense of a forced re-filing later in the product life cycle.

4. Practical recommendations

• Start the project clock at the decision to enter Indonesia, and launch licence holder qualification, document notarisation and legalisation, and Indonesian-language labelling in parallel from day one.
• Evaluate licence holder candidates on IDAK and CDAKB status before commercial terms are negotiated, since the licence holder named on the certificate is the legal rights holder and switching later requires a fresh marketing authorisation application.
• Build the plan on the official evaluation clock of 21 working days for Class A, 36 for Class B and C, and 55 for Class D, and layer the industry experience values for the end-to-end duration separately, clearly marked as industry experience values rather than official commitments.
• Prepare the mandatory documents, the CFS from the country of origin and proof of marketing in the country of origin, as gating items; treat CE marking and FDA approval as supplementary evidence that smooths evaluation but never as substitutes.
• Plan for a maximum of two deficiency correction rounds and keep a response pack ready, since deficiency rounds interrupt the evaluation clock and are the main controllable source of schedule slippage within it.
• Sequence the post-certificate actions early: KFA code, e-Katalog, batch-by-batch SKI and post-market reporting all become due once the certificate is granted, and none of them should be discovered for the first time after the certificate arrives.

5. Verification checklist

• □ Permenkes No. 11/2025, Appendix 3 (time limits and document requirements).
• □ Permenkes No. 5/2026, Articles 50 and 58 (certificate before importation).
• □ Permenkes No. 14/2021 (IDAK and CDAKB).
• □ End-to-end durations are industry experience values and are marked as such.

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