PKRT in Indonesia: Household Health Products and the Notification Route

1. Key takeaways

PKRT is a category parallel to medical devices in Indonesia, not a low-risk subset of them, and it runs on its own notification route with its own change-control rules. The boundary between PKRT and devices is decided by the intended-use claim, so the claim must be settled before the filing route is chosen, never after.

• PKRT (Perbekalan Kesehatan Rumah Tangga, household health products) covers implements, materials or mixtures used to maintain human health in households and public places. It is a parallel category to medical devices, and the two are frequently confused.
• Typical categories include tissues and cotton products (cosmetic cotton, facial tissues, wet wipes, cotton swabs and similar), detergent preparations (laundry soaps and enzymes, detergents, fabric softeners, bleaches), cleaning products (for kitchenware, glass, floors, metal, furniture, carpets, water purifiers, pipe cleaners, hand soaps), maternal and infant care products (feeding bottles and teats, infant diapers, breast milk containers, disposable breast milk absorption pads), disinfection and antibacterial products (disinfectants, antibacterials), fragrances, household insecticides and similar items.
• Route: PKRT Class 1 and Class 2 products follow the notification regime (Notifikasi). New applications are submitted through OSS RBA (oss.go.id, using the OSS account and password), while renewals, changes, and renewal with changes are submitted through Regalkes.
• The evaluation time limit under the notification regime is 12 working days, per the Permenkes 11/2025 standard.
• Changes requiring a fresh application include: product renaming, change of importer, change of factory or manufacturer, change of factory or manufacturer address, change of specification, change of raw materials or formulation, and change of company ownership (merger or acquisition).
• Changes not requiring a fresh application include: renaming of the factory with the address unchanged, renaming of the principal, changes in packaging specification, and changes in packaging container.
• Each declaration submitted through Regalkes must bear the required stamp duty (under UU 10/2020, with a practical estimate of Rp10,000 per document).
• The notification regime is materially faster than the device registration routes, but speed depends on clean paperwork: the category lists are long and heterogeneous, and products that sit near the PKRT-device boundary are the ones that generate most of the trouble in practice.

2. Legal basis

The PKRT notification regime rests on four instruments. Permenkes No. 14/2021 establishes the risk-based business licensing standards under which the notification operates. The Kemenkes notification letter UM.01.05/5/0024/2022, effective 10 January 2022, governs the implementation of the notification regime for PKRT Class 1 and Class 2 products. Permenkes No. 11/2025 supplies the service standard, including the 12-working-day evaluation time limit for the notification route, and also distinguishes the submission channels, with new notifications filed through OSS RBA and renewals and changes filed through Regalkes. Finally, UU No. 10/2020 contains the provisions on stamp duty that apply to the declarations submitted through Regalkes, for which the practical estimate is Rp10,000 per document. Read together, these four instruments define the scope of the category, the route for each transaction type, the clock that governs the review, and the fiscal formality attached to each declaration. For a portfolio of household health products, this structure means that most questions can be answered from a single well-organised reference sheet: which class the product sits in, which channel takes the transaction, how long the review runs, and what the declaration must carry.

3. Expert insights

Maternal and infant care products and disinfection and antibacterial products are the ambiguous zone for many companies. The same wet wipe from the same factory, claimed for household cleaning, is PKRT; claimed for preoperative skin disinfection, it may be determined to be a device. The direction of the analysis is fixed: first define the intended use, then determine the filing route, and never reverse the order. Reversing the order, by picking the cheaper or faster route first and writing claims to fit, produces filings whose claims do not match the product reality, and a mismatch discovered during evaluation or post-market control is far more expensive than the time saved at the start. The change-control lists reward the same discipline: knowing exactly which changes force a fresh application and which do not allows commercial decisions such as importer changes or ownership restructurings to be timed with the regulatory calendar instead of colliding with it. A portfolio-level change register, listing every product with its notification number, its classification within PKRT, and the change types that would trigger a fresh application, turns this knowledge into a routine check that any commercial team can run before signing an agreement, rather than a specialist question asked after the deal terms have been fixed.

4. Practical recommendations

• Settle the intended-use claim before choosing the filing route, and check whether a product claim such as preoperative skin disinfection pulls the product out of PKRT and into the device regime.
• Submit new Class 1 and Class 2 notifications through OSS RBA and route renewals, changes, and renewal with changes through Regalkes, keeping the two channels clearly separated in the project plan.
• Map every contemplated commercial change against the change-control lists before executing it: product renaming, importer change, factory or manufacturer change, address change, specification change, raw material or formulation change, and ownership change by merger or acquisition all require a fresh application, while factory renaming with the address unchanged, principal renaming, and packaging specification or container changes do not.
• Provide for the stamp duty on each declaration submitted through Regalkes, budgeting on the practical estimate of Rp10,000 per document under UU 10/2020.
• Track the 12-working-day notification clock against the launch plan, remembering that the clock covers evaluation and that document readiness before submission is what keeps the clock meaningful.

5. Verification checklist

• □ Permenkes No. 14/2021 (risk-based business licensing standards).
• □ Kemenkes notification letter UM.01.05/5/0024/2022 (effective 10 January 2022, implementation of the notification regime for PKRT Class 1 and 2).
• □ Permenkes No. 11/2025 (12-working-day notification regime).
• □ UU No. 10/2020, stamp duty provisions.

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