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Under Indonesian law, every PKRT (Perbekalan Kesehatan Rumah Tangga) product must be assigned a risk class before it can be submitted for marketing authorization. The classification system — established under Permenkes No. 62 Tahun 2017 — divides all household health products into three classes based on the level of risk they pose to human health through normal use.
This class determines everything: the documentation depth required, whether laboratory testing is mandatory, how long the evaluation process will take, and how much the government registration fee (PNBP) will cost. Getting the classification right at the start is essential — submitting under the wrong class can result in application rejection or additional costs.
New to PKRT Registration in Indonesia?
This article focuses on risk classification. For the complete end-to-end registration process — including required documents, the Regalkes portal, halal certification, and timelines — see our full guide.
Household Health Supplies Registration Indonesia (PKRT) – Complete Guide 2026 →1. How PKRT Risk Classification Works
According to Permenkes No. 62 Tahun 2017, PKRT products are divided into three risk classes — Class 1 (low), Class 2 (medium), and Class 3 (high) — based on the potential harm the product may cause to its user under normal conditions of use. Risk is primarily determined by the type and concentration of active ingredients, the product’s intended function, and whether it contains substances with toxic, corrosive, or carcinogenic potential.
The applicant — whether a local manufacturer or an importer — is responsible for self-declaring the class at the time of pre-registration. The Kemenkes evaluator will then verify and, if necessary, correct the declared class. An incorrect classification can delay the process or result in underpayment of PNBP fees, which must be rectified before evaluation continues.
Important: PKRT uses a 3-class system (Class I, II, III). This is different from Medical Devices (Alat Kesehatan), which uses a 4-class system (Class A, B, C, D). A common mistake is confusing the two — make sure you are working with the correct regulatory pathway for your product type.
2. Class I — Low Risk
Class I covers household health products that do not cause significant harm under normal conditions of use. Specifically, these products do not trigger irritation, corrosive reactions, or carcinogenic effects. They are typically physical materials — such as absorbent or wiping products — rather than chemical formulations.
Class I products benefit from the simplest registration pathway. They do not require laboratory testing as part of the application process, and the Kemenkes evaluation timeline is the shortest among all three classes.
Typical Class I Products
- Facial tissue, toilet tissue, and dining tissue
- Wet tissue / refreshing wipes (without antiseptic agents)
- Cotton balls and cotton rolls for cosmetic use
- Cotton buds (non-clinical)
- Paper towels
Registration Requirements for Class I
- Completed registration form (uploaded via the Regalkes portal)
- Administrative documents: company license (NIB/SIUP), NPWP, and letter of authorization (for imported products)
- Formula information and manufacturing flow
- Product specification and stability data
- Labeling artwork (2 color copies submitted to Kemenkes counter)
- No lab testing certificate required
Note on cotton products: Despite being Class I (low risk), cotton products must undergo a fluorescence test conducted at an independent laboratory in Indonesia. This specific test is a mandatory exception even for low-risk items.
3. Class II — Medium Risk
Class II covers products that may cause irritation or have corrosive properties under certain conditions, but do not carry the risk of serious long-term harm such as carcinogenicity. This is the broadest and most diverse class — encompassing the majority of chemical household cleaning products, antiseptics, fragrances, and baby equipment.
Under the post-Omnibus Law notification system (Permenkes No. 14/2021), Class II products are eligible for a simplified notification pathway (Izin Edar Notifikasi), which reduces documentation requirements compared to the full registration required for Class III. However, laboratory testing is still required for most Class II products.
Typical Class II Products
- Washing preparations: Laundry detergent, fabric softener, laundry bleach, washing enzyme, hand wash soap
- Household cleaners: Floor cleaner, glass cleaner, toilet bowl cleaner, dishwashing liquid, furniture polish, carpet cleaner
- Antiseptics & disinfectants: Hand sanitizer, antiseptic hand wash, surface disinfectants
- Fragrances / air fresheners: Room air fresheners, car air fresheners, refrigerator deodorizers, camphor
- Baby care equipment: Baby diapers, feeding bottles, pacifiers, breast milk storage containers
- Other: Water purifiers, shoe cleaners, car cleaners
Registration Requirements for Class II
- All administrative and formula documents (same as Class I)
- Laboratory testing required — Certificate of Analysis (CoA) from an accredited Indonesian lab
- Product Conformity Document (DKP) including raw material specs and finished product stability data
- Labeling artwork in color (2 copies submitted to Kemenkes)
- For imported products: Certificate of Free Sale (CFS) + Letter of Authorization legalized by Indonesian Embassy (LoA valid min. 2 years)
Class II Special Testing Requirements:
- Disinfectants: Must pass a phenol coefficient test at an independent Indonesian laboratory
- Antiseptics: Must pass an antimicrobial efficacy test (5-log reduction per EN 1276:2019 for antibacterial claims)
- Baby diapers: Must pass fluorescence and absorbency tests at an independent Indonesian laboratory
- Baby feeding bottles (plastic): Must pass a BPA-free test at an independent laboratory
4. Class III — High Risk
Class III is reserved for products that contain pesticide-active substances capable of causing serious harm, including carcinogenicity and acute toxicity. These are products specifically designed to kill or repel biological organisms — such as insects, rodents, or other household pests.
Class III requires the most rigorous regulatory process. Unlike Class I and II, these products must go through a full marketing authorization registration (not a simplified notification) and require additional approval from the Indonesian Pesticide Commission (Komisi Pestisida) under the Ministry of Agriculture before a PKRT marketing authorization can be issued.
Typical Class III Products
- Insecticides & repellents: Mosquito coils, insecticide aerosol sprays, electric mosquito vaporizers, mosquito repellent lotions (DEET-based), mosquito patches
- Rodent control: Rat poison baits and rodenticide preparations
- Head lice control: Pediculicide shampoos and lotions
- Pet pest control: Flea and tick control preparations for pets (non-livestock)
Registration Requirements for Class III
- All standard administrative and technical documents (formula, specifications, labeling, CFS, LoA)
- Decision Letter from the Ministry of Agriculture (SK Mentan) — registration and permanent license for the pesticide ingredient
- Efficacy test (uji efikasi) and active ingredient concentration test (uji kadar bahan aktif)
- Toxicity test (uji toksisitas) — for repellent and aerosol products
- Labeling approved by the Pesticide Committee (Komite Pestisida)
- All Class III hardcopy documents must be physically submitted to the Kemenkes Integrated Services Unit (Unit Layanan Terpadu)
Warning: Class III requires coordination with two separate government bodies — the Ministry of Agriculture (for pesticide approval) and the Ministry of Health (for PKRT marketing authorization). This dual-track requirement significantly extends the overall timeline. Companies planning to register Class III products should allow considerably more lead time than for Class I or II.
5. Side-by-Side Class Comparison
The table below summarizes the key differences across all three PKRT classes, covering risk level, typical products, lab testing obligations, and the registration pathway applicable to each.
| Criteria | Class I | Class II | Class III |
|---|---|---|---|
| Risk Level | Low | Medium | High |
| Product Examples | Tissue, cotton, cotton buds, paper towels | Detergent, hand sanitizer, disinfectant, baby diaper, air freshener, floor cleaner | Mosquito coils, insecticide spray, repellent lotion, rat bait, head lice treatment |
| Lab Testing | Not required (except cotton fluorescence) | Required (CoA from accredited Indonesian lab) | Required + toxicity & efficacy testing |
| Registration Type | Notification (Izin Edar Notifikasi) | Notification (Izin Edar Notifikasi) | Full Registration + Ministry of Agriculture approval |
| Evaluation Timeline | 45 calendar days | 80 calendar days | 100 calendar days |
| Warning Label Required | No | Yes (for some products) | Yes (mandatory) |
* Classification verification by evaluator takes an additional 7 calendar days before the evaluation period begins. All timelines above refer to the initial evaluation stage only (Evaluasi I).
6. Key Factors That Determine Your Product’s Class
If your product sits on the boundary between two classes — or if you are unsure which class applies — evaluators at Kemenkes will assess based on four primary criteria defined in the classification guidelines:
| Factor | What Kemenkes Assesses | Example Impact on Class |
|---|---|---|
| Product Name | How the product is commercially labeled and described | A “mosquito repellent tissue” may be reclassified as Class III despite its physical form |
| Product Type | The PKRT category it falls into (tissue, pesticide, antiseptic, etc.) | All household pesticides are automatically Class III regardless of concentration |
| Intended Use | The stated purpose of the product on labeling and registration form | A hand sanitizer claiming antiviral efficacy is treated more strictly than one claiming basic hygiene |
| Method of Use | How the product is applied (spray, topical, inhalation, surface contact) | An inhalable aerosol product carries higher risk than the same formula in cream form |
Practical Tip: Kemenkes allows applicants to cross-reference product types against the US FDA Code of Federal Regulations (CFR) as a reference guide for classification decisions. This is particularly useful for novel or multi-function products that do not have a clear Indonesian precedent.
7. Government Fees (PNBP) and Processing Timelines
The official government registration fee — known as PNBP (Penerimaan Negara Bukan Pajak) — is set by government regulation and differs by class. Fees must be paid and the payment receipt uploaded to the Regalkes portal within 14 days of receiving the class verification result. Failure to pay within this window will cause the application to lapse.
| Application Type | Class I | Class II | Class III |
|---|---|---|---|
| New Registration (PNBP) | IDR 1,000,000 | IDR 2,000,000 | IDR 3,000,000 |
| Renewal / Variation (PNBP) | IDR 500,000 | IDR 1,000,000 | IDR 1,000,000 |
| Class Verification (All) | 7 calendar days | 7 calendar days | 7 calendar days |
| Evaluation Period (New) | 45 days | 80 days | 100 days |
| Evaluation Period (Renewal / Variation) | 45 days | 45 days | 45 days |
Source: Kemenkes RI Pedoman Pelayanan Izin Edar PKRT (2016) based on PP No. 21 Tahun 2013. Fees are subject to update by government regulation.
Key note on PNBP: If you self-declare an incorrect (lower) class, any PNBP shortfall must be paid before the evaluation continues — and the time spent waiting counts against your application window. Overpayment is non-refundable and cannot be transferred to another application.
Now that you know your product’s class, the next step is preparing your full registration dossier. Get the complete documentation checklist, Regalkes submission walkthrough, halal certification requirements, and more in our main guide.
Read the Complete PKRT Registration Guide 2026 →Conclusion
PKRT risk classification is the foundational step of the entire registration process in Indonesia. Class I (low risk) products — such as tissues and cotton — follow the simplest path with no lab testing and a 45-day evaluation period. Class II (medium risk) products — the broadest category, covering detergents, antiseptics, baby equipment, and air fresheners — require laboratory testing and an 80-day evaluation. Class III (high risk) products — exclusively those containing pesticide-active substances — carry the most demanding requirements, including toxicity testing, Ministry of Agriculture approval, and a 100-day evaluation window. Getting the classification right from the outset determines your documentation requirements, your timeline, and your overall cost of compliance.
