In this article, we’ll provide a guide on BPOM Indonesia registration across 4 key imported products; Medical Device, Cosmetic/Beauty, Food Supplements, Food and Beverage.
. Indonesia has a population size of over 270 million, 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 expanding quickly, and so is their consumption in terms of volume and variety. Continued efforts to ease regulations of foreign investments, and fast digital adoption across Indonesia are one of the few reasons more foreign companies and investors are focusing on Indonesia.
The graphic below displays the number of products that have been registered at BPOM Indonesian in 2021.
In short, BPOM Indonesia (Badan Pengawas Obat dan Makanan) is equivalent to an Indonesia FDA (Food and Drug Administration). It oversees national policies, standardizations, regulations and Indonesia 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;
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.
Here are a few quality standards Indonesia products are aligned to:
The basic requirements for registering F&B, medical devices, health supplements, and cosmetics in Indonesia undergo a largely similar process.
The application starts online and trading companies are required to submit the following documents:
Each document has a specific set of criteria. For a successful application, reach out to our consultants (via the form below) for more details
Food and beverage products are defined as any product, whether unprocessed or processed, 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. However, if the restaurant decided to produce kebabs in the form of 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 important to note, Food and beverages are categorized based on their risk levels – there are 4 categories.
Various factors determine the risk level, such as the 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:
Our consultants can provide you with detailed procedures upon request.
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:
The procedures of registering health supplements are the same as food and beverages, with a summary in the following:
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:
As for medical device registration in Indonesia, you should undertake the following summarized procedures:
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:
Continue reading 4 Costly Mistakes in Cosmetic Products Registration in Indonesia.
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:
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.
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 special purpose vehicle 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 special purpose vehicle or a distributor.
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.
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 be in touch with you.