Indonesia Medical Device Regulatory Authority: Kemenkes and Ditjen Farmalkes

1. Key takeaways

The regulatory authority for medical devices in Indonesia is the Ministry of Health (Kementerian Kesehatan, commonly abbreviated Kemenkes). Within Kemenkes, executive responsibility sits with the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes), and the device evaluation function rests with the directorate responsible for the assessment of medical devices and household health supplies. The competent authority is not BPOM.

• BPOM (the National Drug and Food Control Agency) regulates drugs, food, cosmetics, health supplements and traditional medicines. It does not regulate medical devices or in vitro diagnostic reagents. This is one of the most frequent errors found in Chinese-language materials about Indonesia.
• The two frameworks operate in parallel. If a company carries both a pharmaceutical product line and a device product line, it must engage the two systems separately.
• The first layer of the legal basis is Law No. 17 of 2023 on Health (in force since August 2023, commonly known as the Omnibus Health Law). Its Article 143 provides that manufacturing or distributing medical devices requires a business licence (perizinan berusaha). This article is the starting point of the entire Indonesian device regulatory regime.
• Indonesia applies a dual-layer structure of product licence plus corporate licence, and both layers are tied to an Indonesian local entity. At the product layer, an Izin Edar must be obtained (known as AKL for imported devices). At the corporate layer, the licence holder must be an Indonesian local legal entity holding an IDAK distribution licence.
• Foreign manufacturers cannot hold the licence directly; they may only appoint a local licence holder. The arrangement resembles the European authorised representative model in appearance but differs in substance, because the Indonesian licence holder is not a representative acting on behalf of the manufacturer but the rights holder named on the certificate itself.

2. Legal basis

The statutory foundation for this allocation of authority is Law No. 17 of 2023 on Health, which entered into force in August 2023 and is commonly referred to as the Omnibus Health Law. Article 143 of that law establishes that the manufacture or distribution of medical devices is subject to a business licence under the perizinan berusaha regime. This provision is the parent-law starting point for all device regulation in Indonesia, and everything downstream, including the implementing ministry regulations and the technical guidance issued by Ditjen Farmalkes, ultimately traces back to it. In practice, this means that any argument about whether a product requires registration, which body must receive the submission, or which licence category applies should be anchored to this article and to the implementing regulations issued under it, not to secondary commentary.

The organisational allocation of functions between Kemenkes and BPOM follows from the same statutory framework. Kemenkes, through Ditjen Farmalkes, administers medical devices and household health supplies, while BPOM administers drugs, food, cosmetics, health supplements and traditional medicines. Companies with mixed portfolios should treat the two channels as fully separate tracks with their own dossiers, portals and licence holders, rather than assuming that an approval or a relationship built under one framework creates any entitlement or shortcut under the other.Misunderstandings on this single allocation question are among the costliest errors observed in practice, because a submission lodged with the wrong agency wastes an entire cycle and must be restarted under the correct framework.

3. Expert insights

The point that foreign manufacturers most need to understand first is the dual-layer structure. Indonesia separates the product licence from the corporate licence, and it binds both layers to an Indonesian local entity. At the product layer the market authorisation is the Izin Edar, and for imported devices this authorisation carries the AKL designation. At the corporate layer the party named as licence holder must be an Indonesian local legal entity that holds the IDAK distribution licence. A foreign manufacturer cannot hold the certificate in its own name; its only option is to appoint a local licence holder. This is where the comparison with the European model breaks down. In the European Union the authorised representative performs a defined representative function while the manufacturer remains the rights holder of the CE marking. In Indonesia the local licence holder is the rights holder of the certificate itself. That difference has direct commercial consequences for exclusivity, transferability and control of the registration, and it should be evaluated before any distribution agreement is signed rather than after. Treating the local holder as a mere formality is the single most common structural mistake seen among first-time entrants to the market.

4. Practical recommendations

• Assess whether an Indonesian partner is genuinely qualified to hold a licence by checking three things: a valid IDAK distribution licence, a valid CDAKB certificate, and AKL certificates actually held in the partner’s name that can be found in the public search function of Kemenkes.
• Only when all three items are present should the partner be regarded as having real licence-holding capability. A business licence and a marketing brochure alone are not sufficient evidence.
• Do not assume that a partner active in drugs, food or cosmetics is therefore competent for devices, because BPOM and Kemenkes run separate parallel frameworks and experience in one does not transfer to the other.
• Before signing any appointment or distribution agreement, clarify in writing who will appear as the licence holder on the AKL certificate and how changes of licence holder would be handled, given that the local holder is the rights holder on the certificate.
• If the portfolio includes both devices and pharmaceuticals, plan the two regulatory tracks separately from the outset, including separate documentation, separate submissions and separate internal ownership of each track.

5. Verification checklist

• □ Undang-Undang No. 17 Tahun 2023 tentang Kesehatan, Article 143.
• □ Kemenkes organisational structure (Permenkes No. 21 Tahun 2024).
• □ Ditjen Farmalkes official website farmalkes.kemkes.go.id and its statement of functions.
• □ Regalkes portal regalkes.kemkes.go.id and its public search function.

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