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.
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:
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The certification issued by BPOM in Indonesia serves several important purposes. However, the most important purpose of the certificate is to ensure product safety and quality before being released into the market.
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.
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.
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.
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.
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.
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Beyond its regulatory functions, BPOM in Indonesia also conducts research to advance public health.
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.
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 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.
The registration procedures for health supplements closely mirror those for food and beverages, ensuring that products are safe and compliant with regulations.
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.
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:
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BPOM certification employs three distinct codes to differentiate registered products in the market.
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:
Go to the BPOM or the INSW website (Indonesia National Single Window) and create your account using Single Sign-On.
Here's what you'll need to upload:
Complete the e-payment for Non-Tax Revenue (PNBP).
Now, upload these additional documents:
Obtaining certification for your product registration in Indonesia can be complex and time-consuming. Ascentium Indonesia is your expert throughout this intricate procedure, ensuring compliance with Indonesian regulations.
We specialize in streamlining the registration process for: