Importing products into Indonesia, especially those in the food, beverage, cosmetics, and pharmaceutical categories, requires strict compliance with national regulations. One of the most critical steps in this process is registering the imported product with the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan or BPOM). For businesses planning to enter the Indonesian market in 2025, understanding the updated procedures and requirements for BPOM registration is essential. This article provides a detailed, step-by-step guide on how to register imported products with BPOM, including tips for a smooth process.
Understanding BPOM and Its Role
What is BPOM?
BPOM is Indonesia’s primary regulatory body responsible for ensuring the safety, efficacy, and quality of food, medicine, cosmetics, and health supplements available in the Indonesian market. The agency regulates both locally produced and imported products, and it enforces compliance with standards to protect public health.
Why BPOM Registration is Important
Registering with BPOM is a legal requirement. Products that are not registered cannot be legally sold or distributed in Indonesia. Furthermore, BPOM registration gives your product legitimacy, builds consumer trust, and provides protection against counterfeit goods.
Categories of Products That Require BPOM Registration
Imported products that typically require BPOM registration include:
- Processed food and beverages
- Health supplements
- Traditional medicines
- Cosmetics
- Over-the-counter and prescription medicines
- Household health supplies (e.g., disinfectants)
Each category may have specific requirements and evaluation processes, so it’s crucial to determine your product type accurately.
Indonesian Regulations
The following are key regulations that govern BPOM registration and product importation in Indonesia:
- Law No. 17 Tahun 2023 on Health: This comprehensive health law consolidates and updates previous legislation governing the healthcare sector. It provides a legal framework for the safety, production, distribution, and registration of pharmaceutical, food, and health-related products, including those that are imported.
- Government Regulation in Lieu of Law (Perppu) No. 2 Tahun 2022 on Cipta Kerja: This regulation streamlines business licensing procedures to enhance investment opportunities and economic growth. It simplifies import licensing processes and integrates them into a centralized digital system (OSS).
- BPOM Regulation No. 23 Tahun 2023 on Processed Food Registration: This is the primary regulation governing the registration of processed food products. It sets out the classification system, assessment criteria, labeling standards, and documentation requirements aligned with international best practices.
- BPOM Regulation No. 28 Tahun 2023: Focuses on post-market surveillance. It includes provisions for risk-based inspections, compliance enforcement, and evaluation of products that are already approved and circulating in the market.
- Regulation of the Minister of Health No. 11 Tahun 2020 about Online Integrated Business Licensing for the Health Sector: This regulation mandates the use of the Online Single Submission (OSS) system for all business licensing in the health sector. It ensures that all entities engaged in product registration or distribution are validated through a unified digital platform.
- Ministry of Trade Regulation No. 8 Tahun 2024: This regulation governs the procedures and requirements for the importation of goods into Indonesia, including import permits, documentation standards, and labeling obligations.
- BPOM E-Registration Guidelines: These are internal procedural guides that explain the steps for digital registration with BPOM. They cover document submission, platform usage, processing timelines, and status tracking through the BPOM online system.
Step-by-Step Guide to Register Imported Products with BPOM in 2025
Step 1: Establish a Legal Entity in Indonesia
Foreign companies cannot register products directly with BPOM. You must appoint a local legal entity, usually in the form of a registered Indonesian company (PT PMA or local distributor), to act as the importer and product registration holder.
Step 2: Obtain an Importer Identification Number (API)
Your appointed Indonesian entity must obtain an Importer Identification Number (API), which is required to legally import goods into Indonesia. The issuance of the Importer Identification Number (API) is now integrated through the Online Single Submission (OSS) system, in accordance with Government Regulation in Lieu of Law (Perppu) No. 2 of 2022 on Job Creation. This integration allows the Business Identification Number (NIB) to also serve as an Importer Identification Number, both API-U and API-P.
Step 3: Secure a Distribution License (PBF for Pharmaceuticals)
Depending on the product type, your local entity must hold the appropriate licenses based on the product type. For pharmaceuticals and supplements, a Pharmaceutical Wholesaler License (PBF) is required under MoH Regulation No. 11/2020. SIUP and MoH Regulation No. 1175/2010 have been replaced by the OSS system. In accordance with Article 3 of BPOM Regulation No. 28/2023, imports of drugs, traditional medicines, quasi-drugs, supplements, or cosmetics must include a SKI Border issued by the authorized agency at the time of import notification.
Step 4: Product Classification and Pre-Submission Assessment
Determine the classification of your product to identify the correct registration pathway. BPOM provides online tools and guidelines to help you classify your product. This step is crucial as each classification has different document and testing requirements.
Step 5: Laboratory Testing and Product Analysis
All imported products must pass safety and quality assessments. BPOM may require laboratory testing of your product either in their own labs or in certified third-party laboratories. The testing ensures that the product complies with Indonesian standards for ingredients, labeling, and manufacturing as per PP No. 28 Tahun 2024 and PerBPOM No. 21 Tahun 2022.
Step 6: Prepare and Submit Documentation
A comprehensive set of documents is required for BPOM submission, including:
- Product formula and specifications
- Certificate of Free Sale (from the country of origin)
- Good Manufacturing Practice (GMP) certificate
- Product label and packaging design (in Bahasa Indonesia)
- Lab test results
- Import and distributor licenses
- Power of Attorney (if using a third-party registrant)
For more information, please read: Registrasi BPOM
These requirements are aligned with BPOM’s various regulations depending on the product category (e.g., PerBPOM No. 23/2023 for food, PerBPOM No. 28/2023 for cosmetics).
Step 7: Online Submission Through BPOM E-Registration System
BPOM has digitized the registration process through its E-Registration system. Once the documentation is complete, it must be submitted online. The system also allows applicants to track the registration status in real time. This is governed under BPOM’s internal digital policy guidance.
Step 8: Evaluation and Product Approval
BPOM will evaluate the submitted documents and test results. If everything complies with the regulations, BPOM will issue a Marketing Authorization Number (Nomor Izin Edar or NIE). This number must be included on the product packaging.
Step 9: Post-Approval Monitoring
Even after receiving BPOM approval, your product is subject to regular monitoring and audits. This includes market sampling, post-marketing surveillance, and routine inspections to ensure ongoing compliance as required under UU No. 17 Tahun 2023.
Common Challenges in BPOM Registration
Lengthy Registration Times
The registration process can take several months, especially for products with incomplete documentation or those requiring extensive testing.
Language Barriers
All submitted documents must be in Bahasa Indonesia or accompanied by certified translations, which can slow down the process.
Regulatory Changes
BPOM regulations are periodically updated, so staying informed of the latest requirements is essential to avoid delays.
Tips for a Successful BPOM Registration in 2025
- Work with experienced consultants or legal experts familiar with BPOM procedures.
- Ensure all documentation is complete and accurate before submission.
- Choose a reliable and knowledgeable local distributor or importer.
- Be proactive in monitoring regulatory updates from BPOM.
- Allocate sufficient time and budget for testing and translations.
Conclusion
Registering imported products with BPOM in 2025 is a necessary but complex process. It involves coordination between multiple agencies, careful documentation, and adherence to strict regulatory requirements. By understanding each step of the process, preparing thoroughly, and working with the right partners, businesses can successfully navigate the BPOM registration process and enter the Indonesian market with confidence.
CPT Corporate offers end-to-end assistance for businesses looking to register imported products with BPOM. From establishing a local entity and securing the necessary licenses, to handling documentation and liaising with regulatory authorities, CPT Corporate ensures a smooth and compliant registration process. Learn more about our services by visiting CPT Corporate Website.
