What is PKRT product registration? In Indonesia, household health products, or Perbekalan Kesehatan Rumah Tangga (PKRT), refer to a category of products used to maintain health and hygiene in the home environment. Such products must comply with specific regulations to ensure they meet safety and efficacy standards before being placed on the market in Indonesia. PKRT classification Class 1 (low risk): products with minimal health risk, typically items that contain no active or hazardous ingredients. Class 2 (medium risk): products that may pose a medium risk due to active ingredients or specific uses, requiring additional safety information. Class 3 (high risk): products that pose a higher health risk due to potent ingredients (such as pesticides or disinfectants), requiring detailed documentation and regulatory review. How to register your PKRT 1. Identify your PKRT product class. Determine your product's classification under PKRT (Perbekalan Kesehatan Rumah Tangga) according to the household-health-product category and specific regulatory classification. 2. Prepare the necessary documents: company registration and licensing documents, product specifications and labeling, risk classification and assessment report, clinical-trial data for Class 2C and Class 3D, and a declaration of conformity. 3. Gap analysis: a written assessment of the administrative documents, technical documents and applicable supporting documents you submit. 4. Submit the application: submit the application to the Directorate General of Pharmaceuticals and Medical Devices (Direktorat Jenderal Kefarmasian dan Alat Kesehatan, Regalkes) through SINOQUAL. 5. Pay the PNBP fee: complete payment of the Non-Tax State Revenue (PNBP) fee. 6. Assessment: assessors verify and evaluate the PKRT product's risk level, safety, quality and efficacy requirements to confirm whether the applicant can obtain a marketing authorization. The assessment results take one of the following forms: a) marketing-authorization approval; b) a notification to supplement data; c) a rejection letter. 7. Collect the licence certificate: obtain the certificate after the application is approved. Basic document requirements Letter of Authorization (LOA); Certificate of Free Sale (CFS); KBLI 46499; raw-material and packaging specifications; special testing requirements (for specific products); and the production process flow diagram.
FAQ
- How are Indonesia's household health products (PKRT) classified, and what is the registration process?
- In Indonesia, household health products (PKRT, Perbekalan Kesehatan Rumah Tangga) are products used to maintain health and hygiene in the home environment, classified into three risk classes: Class 1 (low risk, typically no active or hazardous ingredients); Class 2 (medium risk, containing active ingredients or for specific uses, requiring additional safety information); and Class 3 (high risk, containing potent ingredients such as pesticides or disinfectants, requiring detailed documentation and regulatory review). The registration process includes: 1) identify the product class; 2) prepare necessary documents (company registration and licensing, product specifications and labeling, risk classification and assessment report, clinical-trial data, etc.); 3) gap analysis; 4) submit the application to the Directorate General of Pharmaceuticals and Medical Devices (Regalkes); 5) pay the PNBP fee; 6) assessment (verifying risk level, safety, quality and efficacy, with results being marketing-authorization approval, a data-supplement notification, or a rejection letter); 7) collect the licence certificate.
