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How to register your product for BPOM in Indonesia

How to register your product for BPOM in Indonesia

The Indonesian Food and Drug Authority, or Badan Pengawas Obat dan Makanan (BPOM), plays a crucial role in safeguarding the country’s food, drugs, and cosmetics safety and quality. BPOM is also responsible for other regulated products entering and circulating within the Indonesian market. As a business looking to import or manufacture these products in Indonesia, obtaining permits from BPOM in Indonesia is crucial for your operation.

Understanding the BPOM certification in Indonesia

In general, Badan Pengawas Obat dan Makanan (BPOM) has functions similar to those of the Food and Drug Administration (FDA) in the United States (US). The main functions of BPOM in Indonesia include:

  • Developing new policies, standards, procedures, and criteria.
  • Updating existing policies, standards, procedures, and measures.
  • Implementing and overseeing the enforcement of policies, standards, practices, and actions.
  • Conducting product laboratory testing.
  • Inspecting manufacturing and distribution facilities, as well as product sampling.
  • Issuing certificates and permits.

Read more: The halal industry: trends and prospects in Indonesia

The purpose of the BPOM certification

Product registration procedures with BPOM in Indonesia

The certification issued by BPOM in Indonesia serves several important purposes. However, the most important certificate is to ensure product safety and quality before being released into the market.

Adherence to regulation

Obtaining BPOM certification is a crucial step in penetrating Indonesia’s market. It is designed to guarantee that the products being sold are safe, high-quality, and meet the strict regulations set by the Indonesian authorities.

Product standardization

The certification provided by BPOM in Indonesia is crucial in promoting standardization and consistency across various product categories. It helps establish a unified framework that fosters reliability and encourages businesses to maintain high-quality standards, ultimately benefiting consumers.

Good manufacturing practices

Manufacturers adhere to strict GMP protocols throughout production, from sourcing raw materials to final product packaging. This effectively reduces the risk of contamination or adulteration.

Product evaluation

The BPOM certification process involves a comprehensive product assessment, including random spot checks, sampling, and laboratory testing. This process identifies potential risks and ensures that the product complies with regulatory standards.

Inspection of manufacturing facilities

The role of BPOM in Indonesia cannot be overstated when it comes to ensuring that manufacturing and distribution facilities comply with regulatory requirements. By performing inspections, BPOM plays a vital role in promoting safety and quality in producing and distributing goods.

Research for policy development

Beyond its regulatory functions, BPOM in Indonesia also conducts research to advance public health.

Who needs to register products for BPOM certification in Indonesia?

Local companies, agents, or distributors are eligible to register food products. However, alternative options exist if you do not have a company or have yet to select an importer.

One option is establishing a foreign-owned company, PT PMA, which allows for 100% foreign ownership. However, the percentage may vary based on specific conditions, such as the sector of business operation.

Foreigners can fully own a PT PMA for importing and exporting goods, but product distribution still requires a local distributor to be appointed. If your business plan includes the distribution of food products, foreign ownership is limited to 67%, necessitating a local partner.

Types of products that must be registered in Indonesia

To have a smooth process of registering your product, it’s important to be familiar with the different types of product registration. Here are a few types you should keep in mind:

Health supplements

Health supplements in Indonesia are formulated to meet individuals’ nutritional needs and enhance their overall health and well-being. These supplements contain various ingredients, including vitamins, minerals, amino acids, and other essential nutrients.

They are typically categorized into three groups based on their ingredients and how they are prepared.

  • Category 1: Comprising isolated materials.
  • Category 2: Including natural materials.
  • Category 3: Involving new forms of preparation, dosages, and applications.

The registration procedures for health supplements closely mirror those for food and beverages, ensuring that products are safe and compliant with regulations.

Medical devices and equipment

In Indonesia, medical devices are classified into four categories, taking into consideration their potential impact on health. The registration process involves a few essential steps that need to be followed.

  • Register the legal entity with the Ministry of Health online.
  • Conduct inspections of local manufacturers if applicable.
  • Register products after determining their class, which permits their distribution and sale.

Cosmetic product registration

Cosmetic products in Indonesia must be registered for each variation, with strict regulations governing labeling, advertising, claim requirements, and ingredient usage. Successful registration requires compliance with these requirements, and the process involves several steps:

  • Register the legal entity online with BPOM.
  • Complete online registration of the manufacturer.
  • Register products, thereby enabling their distribution and sale in the Indonesian market.

BPOM certification codes in Indonesia

BPOM certification employs three distinct codes to differentiate registered products in the market.

  • ML (Makanan Luar): This code is specific to imported processed food and beverage products.
  • MD (Makanan Produksi Dalam Negeri): This code is specific to domestically produced food and beverage products that must adhere to food safety requirements.
  • SP (Sertifikat Penyuluhan): This code is specific to small and medium-sized enterprises (SMEs) receiving assistance from municipal health agencies.

The procedure for obtaining SKI through BPOM registration

It’s important to comply with safety standards set by the Indonesian National Agency of Drug and Food Control (BPOM) when importing medicines, traditional remedies, cosmetics, supplements, and processed foods into Indonesia.

Regulation No. 12 of 2015 governs this process, mandating registration before customs clearance. Follow the outlined steps to obtain a Letter of Import (SKI) from the Head of BPOM:

Step 1: Register online

Go to the BPOM or the INSW website (Indonesia National Single Window) and create your account using Single Sign-On.

Step 2: Gather your documents

Here’s what you’ll need to upload:

  • Application letter
  • Letter of responsibility
  • Importer Identification Number (API) – NIB
  • Trading Business License (SIUP)
  • Tax ID (NPWP)
  • Power of attorney letter for importing (if applicable)
  • List of HS codes for the product
  • Pharmaceutical Industry License (for drug SKI)

Step 3: Payment

Complete the e-payment for Non-Tax Revenue (PNBP).

Step 4: Submit electronic documents

Now, upload these additional documents:

  • Distribution approval license
  • Certificate of analysis
  • Invoice
  • Proof of Payment of Non-Tax Revenue (PNBP)

Extra requirements (depending on your product)

  • Vaccines and serums: Batch/lot release certificate, batch/lot protocol summary, and a letter from the producer.
  • Processed food: Letter of recommendation (may be required).

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What can InCorp Indonesia help with your BPOM certification

Obtaining certification for your product registration in Indonesia can be complex and time-consuming. InCorp Indonesia is your expert throughout this intricate procedure, ensuring compliance with Indonesian regulations.

We specialize in streamlining the registration process for:

Contact our experienced team below for assistance.

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    Pandu Biasramadhan

    Senior Consulting Manager at InCorp Indonesia

    An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

Frequently Asked Questions

    The Indonesian Halal bodies recognize some of the international halal certifications. Nevertheless, since there might be differences in the standards used by each certification body, it is still necessary to process Halal Certification in Indonesia.

    Within the scope of foreign direct investment in Indonesia, foreign investors can typically do business in two ways:

    • Set up a PMA (Perusahaan Modal Asing)
    • PMA is a local subsidiary in the form of a limited liability corporation for foreign investment reasons

    • Set up a RO (Representative Office)

    According to Law No. 25/2007 on Investment, foreign investors are required to establish a PMA company in order to make direct investments and conduct commercial and business activities in Indonesia. A PMA firm in Indonesia is a legally recognized business entity that can engage in various commercial and business operations as long as it complies with the current laws and regulations. As for RO, its purposes include conducting market feasibility studies and liaison activities.

    A newly established PMA company in Indonesia is typically provided with import facilities, tax holidays, tax allowances, or investment allowances.

    • Import facilities
      Investors in Indonesia, particularly in manufacturing, may benefit from import tax exemptions for capital goods and raw materials through the Master List Facility. The imported goods must meet specific criteria, such as not being produced locally or not meeting industry demand despite local production.
    • Tax holiday
      The government offers CIT reductions of 50% or 100% for 5–20 years for listed pioneer industries, based on investment value. After this period, a CIT reduction of 25% or 50% applies for two fiscal years. Non-listed sectors can also apply by meeting criteria demonstrating pioneer industry status.
    • Pioneer industries are industries that have a wide range of connections, provide additional value and high externalities, introduce new technologies, and have strategic value for the national economy.

    • Tax allowance
      For companies in certain designated areas or regions, the government may provide the following tax concessions:
      Net income reduction up to 30% of the amount invested, prorated at 5% annually for six years, on condition that the assets invested are retained for the same duration.
      Accelerated depreciation and/or amortisation deductions
      An extension of tax losses carried forward for a maximum of ten years
      A 10% (or lower if treaty relief is available) withholding tax rate on dividends paid to non-residents
      The applicant eligible has to meet high-level-criteria for the above tax facilities:
      High investment value or for export purposes
      High manpower absorption
      High level of local content
    • Investment allowance
      The government offers a reduction in net income of up to 60% of the investment, distributed at 5% annually over six years of commercial production, contingent upon the retention of invested assets for the same duration. To qualify, applicants must meet business line eligibility criteria and employ a minimum of 300 Indonesian workers in the project.
    • Super deduction
      This facility could be granted to certain businesses, such as:
      60% reduction in net income of the amount of tangible fixed assets invested for labor-intensive industries, distributed throughout a certain time frame.
      Up to 200% reduction in the gross income of the amount spent for human resources development in certain competency activities.
      Up to 300% reduction in gross income of the amount spent for certain R&D activities in Indonesia.

    You will need to register your products with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health) before you can distribute them in Indonesia. It can only be registered with an Indonesian legal entity. Your local distributor will register your product in Indonesia under their entity and become the license holder if you distribute via the entity you choose.

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