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A Look into Indonesia’s Product Registration and Regulation

Indonesia makes an enticing destination for foreign investors engaging in the food and beverage (F&B) as well as cosmetics industries as it boasts the 4th largest population in the world, supported with the rapid growth of the middle class that has significantly contributed to the consumption surge over the years.

Furthermore, as a developing country, Indonesia is in need of more advanced technology in medical devices, thus demanding foreign supply. The healthcare industry, particularly the medical device sector, is something worth diving into.

The graphic below displays the number of products that have been registered at the Indonesian Agency for Drug and Food Control (Badan Pengawas Obat & Makanan – BPOM) in 2021.

BPOM Indonesia Registration - Infographic

What is BPOM and Its Relation to Product Registration in Indonesia?

The BPOM works similarly to the US Food and Drug Administration. It has three important roles: legislation, standardization, and regulation of food and drug products that cover food and beverages, food or health supplements, and cosmetics, among others.

In summary, the BPOM performs the following functions, among others:

  • 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

Essentials of Product Registration in Indonesia

Indonesia’s goal is to improve its foreign direct investment. It is working with other countries to help create a more global standard for product registration. Integration at the regional level includes ASEAN Consultative Committee for Standards and Quality (ACCSQ), Pacific Area Standard Congress (PASC), and the Asia Pacific Laboratory Accreditation Cooperation (APLAC), while at the international level the integration includes Codex Alimentarius Commission (CAC) and International Laboratory Accreditation Cooperation (ILAC).

Basic Requirements

The basic requirements for registering F&B, medical devices, health supplements, and cosmetics in Indonesia are more or less the same.

When submitting an online application, you are required to submit the following documents altogether:

  • 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

For more detailed information on all the requirements of product registration for each specific product, please reach out to our consultants.

Food and Beverages Registration in Indonesia

Food is defined as any product, whether unprocessed or processed, from biological sources. These include farms, water sources, plantations, and forests.

Before being registered, food and beverages are required to be categorized based on risk levels, namely very low risk, low risk, medium risk, and high risk.

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

Various factors determine the risk level, such as use of food additives and statement claims. For specific details, you can contact our consultants.

The following is the summary of the procedures of 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 the detailed procedures upon request.

Health Supplements Registration in Indonesia

BPOM defines health supplements as products that are intended to supplement nutritional needs, maintain, improve and/or improve health function, 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 important 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 of 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

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

In accordance with 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, in accordance with ASEAN Medical Device Directive (AMDD), medical devices can be classified into four classes:

  • Class 1: Low Risk – These are devices or equipment that don’t cause any serious physical harm if they malfunction. Examples include bandages and weighing scales.
  • Class 2: Low to Moderate Risk – These are devices or equipment that may cause a significant but not serious 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 serious 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 are devices or equipment that result in serious physical harm, including death, when they are misused or malfunction. 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.

Cosmetic Product Registration in Indonesia

If you are interested in importing cosmetic products into Indonesia, it is extremely important to take into account different registration for every variation of a cosmetic product. For example, if you are planning to sell different shades of powder, you are required to register every shade with the BPOM. What is more, all cosmetic products must be registered without exception, even for products like toiletries.

Other important details that you need to pay attention to include labeling, advertising, and claim requirements. The use of specific ingredients is also under specific regulations. For example, it is not allowed to use short-term pigments for long-wear cosmetic products. 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)

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, Cekindo will help you with all your problems.

We believe you have a greater chance of success of not only registering your product but also 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 country is notorious for being relaxed in its implementation, more often than not, they are strict.

A violation of any of them could mean serious consequences. At the very least, you cannot register your product.

Under the harmonization rules of the ASEAN, it is implied that products approve 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 need to remember that no foreigner can import products into the country as a sole proprietor. You need to have a more corporate setup. One of the easiest is a PT PMA, but it has a huge minimum investment.

You can also appoint a nominee or partner with a local distributor. We have in-depth knowledge of the pros and cons of each of these options. We can provide you with sound advice. Not only that, we can assist you in setting up your company including searching for a local nominee or a distributor.

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 why project registrations get rejected or take a long time to get approved is the lack of 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.

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

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

Indonesia is a country with so much economic potential, making it beneficial for you. Do not waste such an opportunity.

Get help with product registration in Indonesia, consult with us now by filling in the form below.

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