Guide to PKRT Product Registration in Indonesia

PKRT (Perbekalan Kesehatan Rumah Tangga) also referred to as Household Health Supplies are products used at home or in public places to maintain and care for human health.

If you plan on selling PKRT products in Indonesia, it is mandatory to register your products with the Ministry of Health, specifically the Directorate General of Pharmaceutical and Medical Devices and obtain a Product License. This ensures that your products meet safety and quality standards before they can be sold in Indonesia.

This requirement applies to all PKRT products, whether they are made in Indonesia or imported. Note that medical device registration is a whole different process.

In this article, we will explore the essential of PKRT products registration process in Indonesia including the product classifications and key requirements.

List of PKRT Products and Classifications

PKRT products cover a wide range of household health supplies, including:

• Tissues and Cotton: Beauty cotton, facial tissue, toilet tissue, wet tissue, dining tissue, cotton buds, paper towels.
• Laundry Preparations: Laundry soap, detergent, fabric softener, bleach, washing enzyme, hand soap.
• Cleaners: Kitchenware cleaner, glass cleaner, floor cleaner, toilet cleaner, furniture cleaner.
• Baby Care Tools: Pacifiers, baby diapers, milk bottles.
• Antiseptics and Disinfectants: Antiseptics, disinfectants.
• Fragrances: Room fragrance, car fragrance.
• Household Pesticides: Insect control, head lice control, pet flea control.

These products are categorized into three classes based on their potential risk to consumer health and safety.

• Class 1: Low risk products such as facial tissues, cotton buds, etc.
• Class 2: Moderate risk products such as laundry soap, hand soap, etc
• Class 3: High risk products such as specialized cleaning products with strong acids/bases, products that contain pesticides, and Insect repellents, etc.

This classification system determines the level of scrutiny and documentation required during the registration process. For instance, Class 3 products usually require comprehensive documentation and additional approvals from relevant authorities such as Pesticides Commission and have longer review process.

For more details, refer to Household Health Supplies (PKRT) Registration

Key Requirements for PKRT Product Registration in Indonesia

Before you register your PKRT product in Indonesia, you must meet the following requirements.

• Product Classification: PKRT products must be classified into one of three risk levels: Class 1, Class 2, or Class 3.
• Labeling: Product labeling must comply with Indonesian regulations, including the use of Bahasa Indonesia.
• Instructions for Use: Provide clear instructions for use
• Risk Analysis: Conduct risk analysis to identify potential risks associated with the product.
• Certificate of Free Sale (CFS): Obtain a Certificate of Free Sale (CFS) from the health authority in the country of origin for imported products.

PKRT Product Registration Process

1. Appointing a Product Holder

According to the Regulation of the Minister of Health Number 62 of 2017, only product holders can apply for PKRT product registration. The product holders must have a registered company in Indonesia and can be the producer, producer that assembles the product, authorized distributor or the importer.

Therefore, if you would like to own the product license directly and sell your PKRT products, it is advisable to register a company in Indonesia. Note that company registration comes additional requirements such as minimum capital and hold a business classification related to the product (e.g. wholesale trade).

As an alternative to company registration, you can appoint Emerhub as the product holder. Emerhub will legally own your distribution license. That means, you don’t need to register a company or worry about meeting the local compliance requirements.

However, if you plan to have only one distributor in Indonesia, the third options is to appoint that distributor as your Exclusive Distributor and have them hold the license. This is the easiest but least flexible option.

For most companies, we recommend the first two options—either registering a company or appointing Emerhub as the product holder. This allows you to appoint multiple distributors and gives you flexibility and control over the Indonesian market.

You can book a free consultation with our experts to discuss your plans and needs.

2. Preparation of documents

The documentation for PKRT product registration is divided into four sections:

• Section A: General Information
  • Product name, brand name, manufacturer details, product description, and packaging details.
• Section B: Technical Specifications and Safety Data
  • Ingredients and composition, technical specifications, safety data sheets (SDS), toxicology reports, and quality control measures.
• Section C: Efficacy Data and Usage Instructions
  • Efficacy studies, usage instructions, dosage and application, warnings and precautions, shelf life, and storage conditions.
• Section D: Regulatory Compliance and Existing Approvals
  • Compliance certificates, existing approvals, legal documentation, environmental impact assessments, and declarations of conformity.

3. Evaluation and Verification of PKRT Product

Once you submit all the required documents and pay the application fee, the next step is evaluation and verification. The Ministry of Health evaluates the submitted documents and product to ensure compliance with safety, quality, and efficacy standards in Indonesia.

The evaluation and verification process involves aspects such as risk assessment, inspection of production facilities (if applicable), and thorough testing of PKRT product.

4. Distribution license (Izin Edar)

Once your application is approved, you will have a 3-5 year product license to distribute your household products in Indonesia.

Keep in mind that the distribution license is for the specific product and its specifications. If you make any changes to your product, such as ingredients, then those must be approved by the Ministry of Health before you are allowed to sell them in Indonesia.

Before the expiry, Emerhub will apply for a new distribution license to ensure a smooth process and avoid any issues.

Register Your PKRT Products in Indonesia with Emerhub

Ready to Register your PKRT products in Indonesia? Emerhub’s local experts will help you do that. Whether you want to register a company and own the product license or appoint Emerhub as your product holder, our experts can handle the process on your behalf.

Fill out the form below and we will put you in touch with one of experts in Indonesia.