Product Registration in Indonesia: How to Register Products via BPOM

In this article, we’ll guide you for product registration in Jakarta and other cities in Indonesia across 4 key imported products; Medical Devices, Cosmetics/Beauty, Food Supplements, and Food and Beverage.

Overview of Indonesia’s Product Industry

Indonesia has a population of over 270 million, and its economic status was upgraded to ‘upper-middle-income country’ (from ‘lower-middle-income country’) in July 2020 by World Bank. 

Indonesia’s middle class is growing exponentially. Therefore, the consumption rate is also improving in volume and variety. The growth is part of a continuing effort to ease regulations of foreign investments and fast digital adoption across Indonesia. 

With some advances in place, it becomes one of the few reasons to attract more foreign companies, and investors are focusing on Indonesia.

What Is BPOM Indonesia & Its Role in Indonesia?

In short, Badan Pengawas Obat dan Makanan (BPOM) is equivalent to the Food and Drug Administration (FDA) in Indonesia. The regulatory body oversees national policies, standards, and regulations. 

Whether BPOM Jakarta and other cities in Indonesia also get involved in product classification, such as food, beverages, medicines, medical devices, health supplements, and cosmetics that are imported, distributed, and sold in Indonesia.

In summary, here are the key functions of BPOM;

• Creating new policies, standards, procedures, and criteria
• Updating current/existing policies, standards, procedures, and criteria
• Implementation of the policies, standards, procedures, and criteria, along with supervision afterward
• Laboratory testing of products
• Inspecting building, manufacturing, and distribution facilities and product sampling
• Issuing certificates and permits

Essentials of Product Registration In Indonesia

To improve its economic growth, the Indonesian government has prioritized foreign direct investment as imperative. From a trade perspective, that means working with other countries to help create a global standard for product registration in Jakarta and across Indonesia.

Here are a few quality standards Indonesia products are aligned to:

• ASEAN Consultative Committee for Standards and Quality (ACCSQ)
• Pacific Area Standard Congress (PASC)
• Asia Pacific Laboratory Accreditation Cooperation (APLAC)
• Codex Alimentarius Commission (CAC)
• International Laboratory Accreditation Cooperation (ILAC)

How to Register a Product via BPOM – Basic Requirements

The basic requirements for registering F&B, medical devices, health supplements, and cosmetics in Indonesia undergo a broadly similar process.

The application starts online through the OSS portal. Trading companies are required to submit the following documents:

• Company Documents: Single Business Identity Number (NIB), Company’s Tax ID (NPWP), Trade Business License (SIUP), Importer Identification Number (API), plus Medical Device Distribution License (IPAK) for medical devices.
• Administrative Documents: Letter of Authorization (LoA), Free Sales Certificate, GMP Certificate/ISO.
• Technical Documents: Dossier from Manufacturer

Each document has a specific set of criteria. For a successful application, contact our consultants (via the form below) for more details

BPOM Indonesia Food Regulation & Registration

Food and beverage products are any unprocessed or processed products from biological sources. However, not all food and beverage needs to be registered.

To illustrate this point, we’ll use a case of a Kebab restaurant. The restaurant does not need to register its product online (i.e., kebabs) to BPOM for business in Jakarta and other cities. 

However, if the restaurant decided to produce kebabs as a ready-made frozen meal (like a TV dinner). The company would have to register the product with BPOM. 

Before the registration process starts, it is vital to note food and beverages are categorized based on their risk levels – there are 4 categories.

• Very Low Risk: contains few ingredients without any food additives and animal derivatives and is minimally processed. Examples include olive oil and frozen vegetables.
• Low Risk: Examples include instant noodles, jam, and cereals.
• Medium Risk: usually for mainly processed food with a process of sterilization, pasteurization, and irradiation. Examples include canned food and gluten-free food.
• High Risk: mainly for processed food to be consumed for specific target consumers with specific health conditions. Examples include baby food and food for pregnant women.

Factors such as food additives and statement claims determine the risk level. For specific details, you can contact our consultants. The following is the summary of the procedures for food and beverages registration that you need to go through:

1. Registration of legal entity at the BPOM: carried out online
2. Registration of the facility (warehouse), which is followed up by facility inspection by the local BPOM office in which your facility is located
3. Registration of manufacturer: carried out online
4. Registration of products: products can finally be distributed and sold after getting the food product registration license numbers (valid for five years)

Our consultants can provide you with detailed procedures upon request. 

Health Supplements Registration in Indonesia

BPOM defines health supplements as products intended to supplement nutritional needs, maintain, improve, and/or improve health function, and have nutritional value and/or physiological effects. 

Health supplements contain one or more ingredients in the form of vitamins, minerals, amino acids, and/or other materials (not plants) that can be combined with plants. Furthermore, health supplements are not to be consumed as food.

It is essential to know the categories of health supplements before proceeding further into product registration, which are:

• Category 1: health supplements containing one or more of these materials: vitamin, mineral, carbohydrate, amino acid, protein, fat, or other materials in the form of isolate
• Category 2: health supplements containing one or more of these materials: vitamin, mineral, carbohydrate, amino acid, protein, fat, other isolates, and other materials in the form of natural materials
• Category 3: health supplements of categories 1 and 2 but with a claim of new preparation form, new dosage, new usage, and posology

The procedures for registering health supplements are the same as food and beverages, with a summary in the following:

1. Registration of legal entity at the BPOM: carried out online
2. Registration of the facility (warehouse), which is followed up by facility inspection by the local BPOM office in which your facility is located
3. Registration of manufacturer: carried out online
4. Registration of products: products can finally be distributed and sold after getting the product license numbers (valid for five years)

Medical Devices and Equipment Registration in Indonesia

Like food and beverages and health supplements, before entering the medical device and equipment registration process in Indonesia, take note of the definition and classifications of medical devices.

Under regulation no. 1190/MENKES/PER/VIII/2010-Regarding Medical Devices and Household Products, the medical device is defined as ‘the instruments, apparatuses, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and relieve diseases, treat sick people, recover the health of human beings, and/or form the structure and correct the body function.

Furthermore, per ASEAN Medical Device Directive (AMDD), medical devices can be classified into four classes:

• Class 1: Low Risk – These devices or equipment don’t cause serious physical harm if they malfunction. Examples include bandages and weighing scales.
• Class 2: Low to Moderate Risk – These devices or equipment may cause a significant but non-severe impact on a person’s physical health. Examples include pregnancy self-testing and surgical masks.
• Class 3: Moderate to High Risk –These are devices or equipment that could impact a person’s physical health but don’t lead to severe damage if they malfunction. Class-3 devices are similar to class-2 devices. However, a more thorough evaluation is required. Examples include condoms and contact lenses.
• Class 4: High Risk – These devices or equipment that result in serious physical harm, including death, when misused or malfunctioned. Examples include pacemaker and HIV blood donor screening.

As for medical device registration in Indonesia, you should undertake the following summarized procedures:

1. Registration of legal entity at Ministry of Health: carried out online
2. Registration of manufacturer (local products): MoH inspection to the local manufacturer
3. Registration of products after device class determination: after getting a medical device license (valid for five years or according to the validity of LoA), your medical devices can finally be distributed and sold.

BPOM Indonesia Cosmetic Registration

If you are interested in importing cosmetic products into Indonesia, you must consider additional registration for every variation of a cosmetic product. 

For example, if you plan to sell different shades of powder, you must register every shade with BPOM in Jakarta and across Indonesia. Moreover, all cosmetic products must be reported without exception, even products like toiletries.

Other important details to pay attention to include labeling, advertising, and claim requirements. The use of specific ingredients is also under particular regulations. 

For example, using short-term pigments for long-wear cosmetic products is not allowed. If you need further clarification, please get in touch with our consultants.

To register your cosmetic products, in short, the following steps must be completed:

1. Registration of legal entity at the BPOM: carried out online
2. Registration of manufacturer: carried out online
3. Registration of products: products can finally be distributed and sold after getting the product license numbers (valid for three years)

Continue reading 4 Costly Mistakes in Cosmetic Products Registration in Indonesia.

Product Registration Services in Indonesia from Cekindo

Can you do the product registration in Indonesia by yourself? The answer is yes, but the risks outweigh the benefits. Therefore, InCorp Indonesia (formerly Cekindo) will help you with all your problems.

You have a greater chance of success in registering your product and operating your business smoothly when you rely on professional services.

Here’s how our company can help you manage and avoid the common challenges that come with Indonesian product registration:

1. Confusing and Complex Regulations

Many regulations and laws govern thousands of products that flow into the country. While the government is notorious for being relaxed in its implementation, they are often strict.

A violation of any of them could mean serious consequences. At the very least, you cannot register your product. Moreover, under the harmonization rules of the ASEAN, it is implied that products approved in other participating countries should also be acceptable in Indonesia. But the country still has the final decision on its approval.

In other words, it doesn’t matter if your products have already been approved in the Philippines or Malaysia. They will still go through the long product registration process in Indonesia.

2. Company Setup

Equally important, you must remember that no foreigner can import products into the country as a sole proprietor. So you need to have a more corporate setup. One of the easiest is a PT PMA, but it has a substantial minimum investment.

3. Insufficient Documentation

The Indonesian product registration process takes time. Some of them can last for 2 months to a full year. For that reason, you need to get it right the first time.

One of the biggest reasons project registrations get rejected or take a long time to get approved is the need for complete and proper documents, but we also understand the challenge.

Some of these papers should come from the country of origin, others from local laboratories. You also need to acquire the corresponding business import permits and licenses.

InCorp Indonesia (formerly Cekindo) saves you all the trouble. We handle all your paperwork, including the submission and status updates. For example, we can already perform a pre-audit with halal, so you can make the necessary corrections before applying for the certification.

Find out how we can simplify your market entry and product registration in Indonesia. Drop us your questions in the form below, and a product specialist will contact you.