Distributor Exclusivity and SKU Allocation Rules for Medical Devices in Indonesia

1. Key takeaways

Can one product be appointed to multiple distributors in Indonesia? The answer is no. The rule is that a brand may have multiple distributors, but each must correspond to different SKUs. Giving product one to distributor A and product two to distributor B is permissible; giving product one to A, B and C simultaneously is not. The reason is structural: each product corresponds to one marketing authorisation, and one authorisation has only one licence holder. This single principle drives most of the exclusivity and channel-assignment questions that arise in Indonesian device distribution, and it operates independently of what the parties agree between themselves, because the constraint attaches to the registration certificate rather than to the commercial contract.

• One product equals one marketing authorisation equals one licence holder; multiple distributors are only possible by splitting the portfolio at SKU level.
• Replacing the importer or licence holder is a variation that requires a new application.
• Termination of the appointment of a distributor or importer by the manufacturer can constitute a statutory ground for revocation of the marketing authorisation under Permenkes 5/2026, Article 51 paragraph (1) point d.
• Combining the two points: changing the agent means re-registration.
• After the new holder’s authorisation is issued, the original holder may continue selling remaining stock for 6 months subject to approval, a transition window rather than a default right.
• Splitting the portfolio at SKU level across distributors is the only legal route to multi-channel coverage under the one-product-one-holder rule.

2. Legal basis

The allocation rule has its origin in Permenkes No. 62/2017, Article 13, under which products of one trade name or brand may be registered by only one PAK or PKRT importer; in current practice the rule is carried forward under Permenkes 5/2026. The revocation consequence sits in Permenkes No. 5/2026, Article 51 paragraph (1) point d, under which termination by the manufacturer of the authorisation granted to a distributor or importer can constitute a statutory ground for revoking the marketing authorisation. The stock transition window appears in the same provision together with Permenkes No. 11/2025, standard 3: once the new holder’s authorisation has been issued, the original holder may, with Kemenkes approval, continue selling remaining inventory for 6 months. The variation and re-application requirements follow the current Kemenkes list of changes requiring new applications. Taken together, the three provisions form a closed loop: the allocation rule fixes one holder per product, the revocation provision makes unilateral exit by the manufacturer legally hazardous, and the stock window provides a limited, approval-based bridge between an outgoing and an incoming holder. Channel design in Indonesia therefore has to be drafted with these consequences in view from the first appointment, not retrofitted after a dispute.

3. Expert insights

The 6-month inventory window deserves careful handling. It is a transition window, not a default right: it requires Kemenkes approval, and it should be written into the commercial agreement and the operational plan rather than assumed. Teams that treat the window as automatic discover the gap when the approval is not in place at handover, leaving stock stranded between holders precisely when sales continuity matters most. Planning the handover around the approval as an explicit milestone, with the window documented in both the regulatory file and the commercial documents, converts a legal allowance into a reliable operational bridge.

SKU allocation is the only compliant path to channel flexibility. Splitting the product line at SKU level across different distributors preserves competitive tension without breaching the one-product-one-holder rule. The trap lies in bundling: where accessories or consumables of the same SKU are sold together with the main equipment, licence ownership must be clarified in advance, otherwise clearance and after-sales conflicts arise in the pattern of the device sitting with A while its consumables sit with B. Import logistics and service obligations both attach to the licence holder, so a mismatch between the equipment licence and the consumable licence surfaces at the border and again in the field. A further practical point concerns the cost of switching agents. Three actions reduce it: set the appointment term at 5 years rather than 2 to reduce renewal frequency; embed change-cooperation obligations and breach liability in the letter of appointment; and, where possible, prefer an independent licence holder structure that decouples holding from distribution. None of these removes the re-registration requirement, but each lowers the frequency and friction of the events that trigger it.

4. Practical recommendations

• Set the appointment term at 5 years rather than 2, reducing the frequency of renewal events over the certificate cycle.
• Write change-cooperation obligations and breach liability into the letter of appointment, so that the handover duties of a departing holder are contractually defined.
• Prefer an independent licence holder structure where channel flexibility matters, decoupling legal holding from commercial distribution.
• Never rely on oral arrangements that give one category to multiple agents: in Indonesia this is not a commercial issue but a compliance issue that can lead to revocation of the certificate.
• Where a conflict is discovered, the correct response is to re-split the SKU assignment, not to leave the overlapping appointment in place.
• Clarify the licence ownership of bundled accessories and consumables before the equipment registration is filed, and document the split in both the appointment documents and the commercial agreement.
• Plan the 6-month stock transition into the handover timetable, securing Kemenkes approval as an explicit deliverable rather than an assumed step.

5. Verification checklist

• □ Confirm Permenkes No. 62/2017, Article 13: products of one trade name or brand may be registered by only one PAK or PKRT importer, currently carried forward under Permenkes 5/2026.
• □ Confirm Permenkes No. 5/2026, Article 51 paragraph (1) point d, on termination as a revocation ground.
• □ Confirm Permenkes No. 11/2025, standard 3, on the 6-month stock window.
• □ Confirm the variation and re-application list in line with current Kemenkes practice, pending verification against the version applicable at submission.

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