How Indonesia Defines Medical Devices, Software and Borderline Products

1. Key takeaways

Indonesia defines medical devices broadly, includes software expressly within the definition, and draws three boundary lines that determine which regulatory regime applies. Getting the categorisation right at the start determines the classification, the dossier, the fees and the timeline that follow, so the definitional questions below are worth answering carefully before any filing decision is made.

• UU 17/2023 defines alat kesehatan as instruments, apparatus, machines, implants and software (perangkat lunak) and similar items used to prevent, diagnose, treat or alleviate disease, restore health, and improve the structure and function of the body, and whose primary intended mechanism of action is not pharmacological, immunological or metabolic.
• Software counts as a device. Software has been written expressly into the device definition since UU 17/2023. On 7 September 2026, Kemenkes issued KMK No. HK.01.07/MENKES/951/2026, the first instrument to regulate software-based devices separately, covering the classification, standards and evidence requirements for SaMD, SiMD and AI devices.
• Before that instrument, software could only be assessed by applying the four-class hardware classification rules; there is now a dedicated pathway.
• The three boundaries are: against drugs, where a primary mechanism that is pharmacological, immunological or metabolic places the product under BPOM; against PKRT, which covers implements, materials or mixtures used to maintain human health in households and public places and is an independent category parallel to devices, not a low-risk subset; and against cosmetics, where the intended use of cleaning, beautifying or altering appearance places the product under BPOM.
• The deciding tools are the intended-use claims plus the primary mechanism of action, read together. A product whose claims promise a therapeutic effect through a pharmacological route will be pulled towards the drug regime regardless of its physical form, while a product whose claims promise cleaning or beautification will be pulled towards cosmetics even if it uses device-like technology.
• Three recurring misjudgements account for most categorisation errors: filing medicated dressings as ordinary dressings, treating AI software with diagnostic output as an ordinary IT system, and excluding disinfection products from the device scope. Each error sends the project down the wrong filing route.

2. Legal basis

The definition originates in UU 17/2023, which establishes that a medical device covers instruments, apparatus, machines, implants and software used for the prevention, diagnosis, treatment and alleviation of disease, the restoration of health, and the improvement of bodily structure and function, provided that the primary intended mechanism of action is not pharmacological, immunological or metabolic. The implementing layer for classification of medical supplies is found in the relevant provisions of Permenkes 5/2026. For software-based devices, KMK No. HK.01.07/MENKES/951/2026, issued on 7 September 2026, provides the first dedicated rules on classification, standards and evidence requirements for SaMD, SiMD and AI devices, replacing the previous situation in which software had no specific pathway and was evaluated by analogy under the hardware classification rules. For products whose categorisation remains unclear, the procedural instrument is the product information confirmation letter (Surat Keterangan Informasi Produk) issued by Ditjen Farmalkes, the service for which is described in the Kemenkes manual on confirmation letters for medical devices and PKRT (Pedoman Pelayanan Surat Keterangan Alat Kesehatan dan PKRT). Reading these instruments in sequence, from the statutory definition through the classification provisions to the software-specific rules, resolves the overwhelming majority of categorisation questions without recourse to guesswork, and leaves a documented trail for the rest.

3. Expert insights

When a categorisation question cannot be resolved internally, it should not be settled by internal discussion alone. Two reliable routes exist: apply to Ditjen Farmalkes for the product information confirmation letter, on which the authority responds in writing whether a given product falls within the device or PKRT scope; or ask the appointed licence holder for precedent, based on its experience in registering products of the same type. Note the limits of the letter: it is not used for customs clearance, it carries a PNBP fee of Rp250,000 and is processed in 3 working days, but it does serve as a written basis for internal categorisation decisions. The most common misjudgements seen in practice are filing drug-eluting or medicated dressings as ordinary dressings, treating AI software with diagnostic output as an ordinary IT system, and excluding disinfection products from the device scope entirely. All three errors lead to the wrong filing route, rejection of the submission, or a later finding that the product is being distributed without a valid licence, each of which is far more expensive than resolving the categorisation question at the outset. A written categorisation decision, supported by either an official letter or a documented precedent, also protects the project when personnel change mid-cycle and the original reasoning is no longer remembered by anyone on the team.

4. Practical recommendations

• Decide categorisation from the intended-use claims and the primary mechanism of action together, and document both in writing before any classification work begins.
• Where the categorisation is genuinely uncertain, obtain the product information confirmation letter from Ditjen Farmalkes rather than relying on internal consensus, and file the letter with the project documentation.
• Alternatively, ask the licence holder to state a precedent from its own registration experience with similar products, and record that reasoning in the project file.
• Treat categorisation as the first gate of the project: once it is wrong, the classification, the dossier content, the fees and the timelines downstream are all wrong, and the rework cost greatly exceeds the cost of confirming the category early.
• For software products, use the dedicated pathway introduced by KMK No. HK.01.07/MENKES/951/2026 instead of forcing the product through the hardware classification rules.

5. Verification checklist

• □ UU 17/2023, device definition provision.
• □ Permenkes 5/2026, medical supplies classification provisions.
• □ KMK No. HK.01.07/MENKES/951/2026 (7 September 2026).
• □ Kemenkes manual on confirmation letters for medical devices and PKRT (Pedoman Pelayanan Surat Keterangan Alat Kesehatan dan PKRT), entry on the product information confirmation letter.

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