Borderline Products: Classifying Devices, Drugs, Cosmetics and PKRT in Indonesia

1. Key takeaways

Two rulers decide whether a product is a device in Indonesia. ① Primary mechanism of action: products acting mainly through pharmacological, immunological or metabolic means belong to drugs (regulated by BPOM); only products not acting primarily through these means can be devices. ② Intended use claims: products for cleaning, beautifying or changing appearance belong to cosmetics (BPOM); instruments and materials for maintaining health in households and public places belong to PKRT (Kemenkes, a category parallel to devices).

• Combination products are judged by the primary mode of action. The typical case is a drug-containing dressing: if the primary action comes from the drug component, the product may be classified as a drug (BPOM); if the drug plays only an auxiliary role, the body of the product stays on the device pathway (Kemenkes). The determination should be completed at the project initiation stage, because the two pathways differ completely in documentation systems, review agencies and timelines.
• The PKRT/device confusion zone. Mother-and-infant care and disinfection/antiseptic products are the two most confusable categories. The same wipes product, claimed as household cleaning, is PKRT (classes 1/2 via the notification route, submitted through OSS, 12 working days); claimed as pre-operative skin disinfection, it may be recognised as a device (marketing authorisation, 21-55 working days). Fix the intended use first, then the pathway — the order cannot be reversed.
• Misjudgment costs three times. ① The application is returned — with the wrong documentation system, reviewers send it straight back; ② unlicensed circulation risk — if a product goes to market via PKRT notification but should have taken the device licence, it may be deemed to be circulating without a marketing authorisation, falling within the destruction and sanction scope; ③ rework cost — reclassification, redoing the documentation, paying the fees again (PNBP is non-refundable).
• When uncertain, ask the authority. Apply for the Product Information Certificate Letter (IDR 250,000, 3 working days, valid for 2 years): Ditjen Farmalkes replies in writing whether the product is a device or PKRT. Note: the letter expressly states it is not for customs clearance, but it is sufficient as the written basis for internal classification and external communication.

2. Legal basis

The classification logic starts with UU No. 17/2023, which contains the device definition and the primary-mechanism test separating devices from drugs. Permenkes No. 5/2026 governs the classification of medical supplies under the current framework. The borderline tool is documented in the Kemenkes Certificate Services Manual product information certificate letter entry: IDR 250,000, 3 working days, valid for 2 years, issued by Ditjen Farmalkes as a written statement of whether a product is a device or PKRT, expressly not usable for customs clearance. The functional division between BPOM and Kemenkes allocates drugs and cosmetics to BPOM and devices and PKRT to Kemenkes. The PKRT notification route rests on Permenkes 14/2021 and the notification letter UM.01.05/5/0024/2022, under which class 1/2 PKRT products are notified through OSS in 12 working days, in contrast to the device marketing authorisation timeline of 21-55 working days.

3. Expert insights

Classification is a strategy decision, not a labelling detail. The two tests — primary mechanism of action and intended use claims — produce consequences that cascade through everything: which agency reviews the file, which documentation system is used, how long the process takes and what it costs. A product that drifts into the wrong category does not merely need a different form; it needs a different dossier built to a different logic for a different reviewer. This is why the determination belongs at project initiation: every week of work done under the wrong assumption is work that must be redone.

The wipes example shows how narrow the line can be. One product, two claims, two regimes: household cleaning puts it on the PKRT notification route through OSS at 12 working days, while pre-operative skin disinfection pushes it toward the device marketing authorisation at 21-55 working days. The difference is not the product but the intended use written on it — and the intended use must be fixed first, because the pathway follows from it, never the reverse. Mother-and-infant care and disinfection/antiseptic products sit closest to this line and should be treated as presumptively borderline until proven otherwise.

The confirmation letter is the cheapest insurance in the Indonesian system. For IDR 250,000 and 3 working days, Ditjen Farmalkes states in writing, with a 2-year validity, whether the product is a device or PKRT. The limitations are known: the letter is expressly not for customs clearance. But for its actual purpose — anchoring internal classification decisions and backing external communication — it converts an arguable judgment call into an authoritative document. Given that misjudgment can cascade into rejection, unlicensed circulation findings, destruction and sanctions, and non-refundable PNBP, the letter is the highest value-per-rupiah step in the entire registration pathway.

4. Practical recommendations

• Make the classification confirmation letter the first expenditure of every borderline project. Apply to Ditjen Farmalkes before any documentation work begins; IDR 250,000 and 3 working days buy certainty for the entire pathway.
• Run the two tests explicitly and record the answers. Document the primary mechanism of action analysis and the intended use claim analysis for every product, so the device/drug/PKRT call is written down rather than assumed.
• Fix the intended use before selecting the pathway. Never reverse the order: the claim determines the route, so drafting claims is a regulatory task, not a marketing task.
• Flag mother-and-infant care and disinfection/antiseptic products as presumptively borderline. These two categories account for most confusions; give them mandatory classification review.
• Remember the letter’s limits. Use it for internal classification and external communication, not for customs clearance, and track its 2-year validity against the project timeline.

5. Verification checklist

• □ UU No. 17/2023 confirmed: device definition and primary mechanism of action test (verified 26 October 2026)
• □ Permenkes No. 5/2026 confirmed: medical supplies classification
• □ Kemenkes Certificate Services Manual confirmed: product information certificate letter entry, IDR 250,000 / 3 working days / 2-year validity
• □ BPOM and Kemenkes functional division mapped to the product portfolio
• □ PKRT notification route confirmed: Permenkes 14/2021, notification letter UM.01.05/5/0024/2022
• □ Classification confirmation letter obtained for all borderline products

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