INDONESIA · MEDICAL DEVICES

Indonesia Medical Device Distributor Change: New Application and Old Stock Transition Rules

When changing a medical device distributor in Indonesia, the first step is to confirm whether the change concerns the licence-holding distributor named on the Izin Edar (marketing authorisation) or a downstream sales partner. The former usually requires the new entity to re-apply for the product licence; the latter cannot be treated as requiring cancellation of the existing licence merely because a sales contract has changed.

For imported products, the difficulty of the handover is not only obtaining a new authorisation letter. The new company’s eligibility to apply, the administrative status of the existing licence, the sell-off of old stock and the responsibility for continuity of supply must all be brought into the same plan. In particular, “termination of appointment by the manufacturer” and “the old licence has been revoked” are not the same point in time in legal terms.

What is the difference between changing the licence-holding distributor and a name change under the same NIB?

The Ministry of Health’s 2021 Guideline on Change Management for Medical Device and In Vitro Diagnostic Medical Device Marketing Authorisations draws a clear distinction: changing or transferring the distributor is a new-application situation, while a change of the distributor’s name under the same business identification number (NIB), and a change of the distributor’s address, fall under the change category. What is discussed here is the distributor information in the product licence, not every downstream dealership relationship. (Source: Basis: Guideline section 2.4.8 items k and l, and section 2.4.9 item b)

The assessment should compare the legal entity, the NIB and the original licence, rather than only whether the brand, management team or ultimate shareholders are the same. If Company A exits and Company B takes over, even where both are controlled by the same group, this cannot be handled as a company name change simply on the basis of an “intra-group adjustment”. Conversely, a qualifying name change where the entity remains the same should not indiscriminately be required to re-submit a full application.

However, the 2021 guideline cannot be used in isolation from the current regulations. Permenkes 5/2026 has revoked the former Regulation 62/2017; its Article 124 retains only those existing implementing provisions that do not conflict with the new regulation. The guideline can therefore be used to understand the classification of changes, but the specific application documents and submission method must be read together with Permenkes 11/2025 and current system requirements; the paper-based procedural steps in the old guideline cannot all be carried over as they stand. (Source: Basis: Articles 124 and 125 of 5/2026)

What capabilities does the new licence-holding company need?

The licence-holding distributor of imported devices carries responsibility for the licence and for product management; it does not merely provide a local name. The licensing standard for imported devices under the current Regulation 11/2025 requires the relevant business licence, proof of good distribution practice, product appointment documents and the applicable product information, and includes post-market procedures for complaints, adverse events and recalls. (Source: Basis: 11/2025 Annex, imported device standard, item 3(b))

The manufacturer’s due diligence should therefore cover product categories, warehousing and distribution capability, the technical person in charge and post-market communication arrangements. The fact that the technical file is provided by the manufacturer does not relieve the new applicant of its local responsibilities; a company that excels at hospital sales is not necessarily suited to taking on all of the licence-holding work.

If the plan is to separate licence holding from commercial sales, the contract should state precisely who holds the Izin Edar, who is responsible for the actual import, who supplies customers and who handles complaints. The downstream sales partner may participate as agreed, but this commercial division of roles cannot substitute for the qualifications each entity requires under the law.

If the existing licence holder does not cooperate, can the manufacturer cancel the old licence by terminating the appointment?

Article 51(1)(d) of Regulation 5/2026 lists the manufacturer’s termination of its appointment of the distributor or importer as a circumstance in which the Izin Edar for medical devices and related products may be revoked. The provision says “may be revoked”, not “automatically lapses when the termination letter is issued”. This basis helps in projects where the existing licence holder is uncooperative, but it does not mean the manufacturer can declare on its own that the administrative registration has been cancelled. (Source: Basis: Article 51(1)(d))

In the project, keep separately the original appointment and the termination notice, evidence of service and of the effective date, the original licence records and the new appointment documents, and verify with the competent authority the administrative processing required. A private contractual dispute and a regulatory decision may exist side by side; resolving one does not necessarily resolve the other.

Nor should one infer from Article 51 that “the old licence must be cancelled before a new one can be applied for”, or that “the old licence is automatically cancelled once the new one is issued”. The article sets out grounds for revocation; it does not independently provide a complete sequence for the transfer of registration. The sequence should be determined by the competent authority’s requirements, the status of the existing licence and eligibility for the stock transition; until these conditions are clear, promising a seamless switch is not prudent.

Can the former distributor’s stock continue to be sold for six months?

A conditional stock sell-off mechanism does exist. The imported device standard in the Annex to Regulation 11/2025 provides that, where a change of agency leaves the former distributor with remaining stock, the sell-off period is six months from the issue of the new Izin Edar. But the company must first obtain the Ministry of Health’s approval of the sell-off application, and the application can only be made while the product licence is still valid. (Source: Basis: imported device standard, item 5(g))

This arrangement addresses remaining stock; it does not give the old entity six months of additional import rights, still less is it a general grace period for a revoked licence. A contractual term that “the former agent may continue selling for half a year” must still satisfy the administrative conditions. If the licence number, distributor name or address on the packaging needs to be changed, the relabelling or over-labelling must also be applied for and approved; the new company’s details cannot simply be affixed and sales begun. (Source: Basis: items 5(g) and (h))

Attention must also be paid to how the new regulation treats products whose licence has been revoked. Articles 89 and 90 of Regulation 5/2026 bring products with a revoked licence within the destruction rules, imposing corresponding obligations on manufacturing, import, distribution and other establishments that hold or store the products concerned. Therefore, if the old licence is later revoked, it cannot be assumed that an earlier sell-off arrangement continues; the competent authority’s decision and the specific stock disposal requirements must be verified. (Source: Basis: Articles 89(1)(c) and 90(1))

From an operational perspective, the sell-off application should be assessed at the same time as the exit of the existing licence is discussed, not done afterwards following cancellation. Because the application conditions depend on the validity of the existing licence, premature revocation may remove the basis for a stock plan that could otherwise have been assessed. The manufacturer should also check the actual remaining batches, shelf life, labelling status and customer demand, to avoid building up “transition stock” that cannot be lawfully cleared within the period.

Are the six-month shortage notice and the stock sell-off the same rule?

No. Article 96(1)(c) of Regulation 5/2026 requires the marketing authorisation holder of health supplies to report a potential shortage to the Minister at least six months before the supply shortage is expected to occur. It applies to the licence holder, and the trigger is a potential shortage, not every change of distribution contract; nor should it be shortened to “every transfer of registration must be reported six months in advance”. (Source: Basis: Articles 94(b) and 96)

If it is already foreseeable that the handover will cause a supply disruption, the reporting assessment should be started early rather than left until stock runs out. For sudden disruptions that could not be foreseen, the handling requirements need to be confirmed with the competent authority as soon as possible; “less than six months” cannot be read as meaning no report is needed. The regulatory acceleration or special channel measures in the provisions are not exemptions the company is automatically entitled to.

Ordinary commercial imports by the new licence-holding company must be based on an Izin Edar having been obtained; they cannot proceed on an application receipt or a new appointment letter alone. Article 58 separately provides an import certification mechanism for specific circumstances, but such exceptions must meet their conditions and obtain the required approvals separately, and cannot be treated as the default route during a normal transfer of registration. (Source: Basis: Article 58(4)-(5))

How do you structure a handover project that does not decouple stock from the licence?

We recommend building a handover file by model, linking the progress of the new application to the existing licence, remaining stock and after-sales records. First verify the new entity’s eligibility and the availability of documents, then confirm the interdependent conditions for the exit of the old appointment, the sell-off application and the effective date of the new licence, and then set the final import and customer delivery arrangements. This sequence is a risk-management approach; it does not replace the competent authority’s requirements for the individual case.

Hypothetical case: A manufacturer plans to have Company B replace Company A as holder of the Izin Edar for an imported device, and Company A still holds four months’ worth of stock. If only “how long the new licence approval takes” is calculated, the sell-off approval is easily overlooked. The more prudent approach is to assess the sell-off application and labelling conditions while the existing licence is still valid, while preparing Company B’s new application in parallel. Once the new licence is approved, the old stock must also be handled within the approved scope; the six-month period cannot be used for additional imports. If a supply gap is still expected, the Article 96 reporting obligation should be assessed separately, rather than treating the sell-off approval as having completed the shortage report.

Nor should the mark of a completed handover be only that the new licence is in hand. The manufacturer should also confirm that the complaint contact has been switched, that old batches remain traceable, and that someone is responsible for repair spare parts and open corrective actions. Otherwise, although the licence change is complete, product support at the hospital end may be interrupted.

When licence holding and sales need to be arranged separately, see MediPass’s Indonesia local licence holding and transfer of registration services.