Navigating Distribution Permits in Indonesia: Simplified Notification System for PKRT Classes 1 and 2
Indonesia has modernized its business licensing framework by shifting to a risk-based licensing system (Perizinan Berusaha Berbasis Risiko). Mandated by Law No. 11/2020 (Cipta Kerja) and Government Regulation No. 5/2021, this change aims to streamline operations, boost investment, and accelerate economic growth.
One important outcome is a simplified permit process for Household Health Supplies (Perbekalan Kesehatan Rumah Tangga / PKRT) regulated under Permenkes No. 14/2021.
1. Understanding PKRT and Distribution Permits
What is PKRT?
PKRT covers tools, materials, or mixtures intended for maintaining human health, designed for use in households and public facilities.
What is an Izin Edar?
An Izin Edar (Distribution Permit) is mandatory for medical devices and PKRT (whether domestically manufactured or imported). The permit is issued only after an assessment of the product’s safety, quality, and efficacy.
The Notification System (Izin Edar Notifikasi)
For PKRT Class 1 & 2, Indonesia offers a simplified notification system. This reduces documentation requirements and approval time, allowing evaluators to focus on higher-risk products. The core requirement is the Product Conformity Document (DKP).
2. PKRT Classification by Risk
Understanding your product class is the first step in the registration process.
| PKRT Class | Risk Level | Examples | Permit Type |
|---|---|---|---|
| Class 1 | Low Risk | Tissue, cotton | Notification |
| Class 2 | Medium Risk | Cleaning products, baby care, antiseptics | Notification |
| Class 3 | High Risk | Household pesticides | Full Registration |
3. Key Requirements for Notification
Applicants must submit documents across three main areas. This applies to both domestic producers and importers.
A. Administrative Requirements
- Application form & Brand documentation
- PKRT Production Certificate (Sertifikat Produksi) or NIB
- NPWP & SIUP / NIB (for importers)
- Integrity Pact and Statement Letter
⚠️ For Imported Products: You must include a Letter of Authorization (LoA) legalized by the Indonesian Embassy (valid min. 2 years) and a Certificate of Free Sale (CFS) from the country of origin.
B. Formula & Manufacturing
- Formula: List active ingredients and excipients (Total = 100%).
- Manufacturing: Flow chart from raw materials to finished product (mixing, filling, packaging).
C. Product Conformity Document (DKP)
- Raw Materials: Specs and Certificates of Analysis (CoA).
- Finished Product: Test results signed by responsible personnel.
- Stability Data: Accelerated and/or real-time studies to determine shelf life (using SNI or validated standards).
4. Labeling Rules and Claims
Labeling is strictly regulated under Permenkes No. 14/2021. All mandatory information must appear in Bahasa Indonesia.
Mandatory Label Info
Must include: Purpose of use, directions, warnings, net content, expiry date, active ingredients (%), manufacturer/importer name and address.
🚫 Prohibited Claims
- Superlative terms (e.g., “terbaik,” “number one,” “super”)
- Medical/therapeutic claims (e.g., “treats,” “virus-free”)
- Cosmetic claims not applicable to PKRT (e.g., “moisturizing”)
- References implying government endorsement
Claims Requiring Validation
- Halal: Requires valid certificate from authorized institution.
- Dermatology Tested: Accredited third-party lab test required.
- Anti-bacterial: Must meet 5-log reduction (EN 1276:2019).
- Anti-virus: Must meet 4-log reduction (EN 14476).
Need Help with PKRT Registration?
Preparing compliant DKP, formula documentation, and stability studies is technically demanding. Insightof Consulting Indonesia (ICI) specializes in regulatory compliance for PKRT, medical devices, and cosmetics. We help you accelerate market entry.
