Tag: registrasi produk indonesia

Having a population that is the 4th largest in the world added with a tremendous growth of the middle class contributing to the consumption surge over the years, Indonesia has become a top destination for foreign investors in the food and beverage (F&B) industry.

What is more, as a country that is still developing rapidly, Indonesia requires more advanced technology in medical devices. Foreign supply, then, is in high demand. The healthcare industry, particularly the medical device sector, is something that foreign investors should explore more.

How to Import Food, Beverages, and Medical Devices into Indonesia in 2023

Basic Requirements

The basic requirements to register F&B and medical devices in Indonesia are almost the same. You are required to submit an online application with 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

Securing an Import License in Indonesia

The Indonesian government has implemented the Online Single Submission (OSS) system since July 2018 to streamline the process of securing an import license, which took up to five months.

All business entities must register through the OSS. Once the registration process is completed, an NIB is issued automatically. The NIB serves as the basic Import License and replaces the Company Registration Certificate (TDP) and Importer Identification Number (API).

How to Register Food and Beverage Products in Indonesia

For F&B and medical device registration, the procedures are slightly different. For a successful F&B registration in Indonesia, the following are required:

• Legal entity (company) registration at BPOM system: carried out online
• Facility (warehouse) registration, followed up by facility inspection
• Manufacturer registration: carried out online
• Product registration: products can be distributed and sold after getting a product license number (valid for five years)

In general, each F&B product must be registered. But, the government has made some exceptions for the following products:

• Used for personal consumption (with amount limit)
• Sold as ingredients to the manufacturer and not sold directly to the end customer
• Short-lasting (its life cycle does not last more than seven days)
• Fast food

Different packaging materials and designs need a separate registration. But, if they come in various sizes and weights, one registration is enough. For example, biscuits will be sold in small and big packaging.

How to Register Medical Devices in Indonesia

To register a medical device, the procedure is as follows:

• Legal entity (company) registration at the Ministry of Health: carried out online
• Manufacturer (local products) registration: MoH inspection to the local manufacturer
• Product registration after device class determination: products can be distributed and sold after getting a medical device license (valid for five years or according to the validity of LoA)

Indonesia implements a four-grade risk evaluation system when medical devices are mishandled or not used properly:

• Class A (low risk): not harmful to humans
• Class B (low to moderate risk): can have some serious effects but will not be considered as a serious accident to humans
• Class C (moderate to high risk): can have very serious effects but will not be considered as a serious accident to humans
• Class D (high risk): can have some serious effects and will be considered as a serious accident to humans

COVID-19 in Indonesia: Requirements for Medical Device Licensing are being Relaxed

To battle the coronavirus, the Indonesian government has relaxed the medical device licensing requirements for importation and distribution, including a one-day service to get Distribution Permit (Izin Edar) for local products.

Medical devices that are eligible are those used for taking care of the COVID-19 pandemic, such as surgical gloves and apparel, ventilators, hand sanitizers, and surface/room disinfectants.

Prior to Import into and Product Registration in Indonesia: PT PMA Setup

Company establishment in Indonesia is required because only companies that are legally registered in Indonesia with valid licenses can register either food, beverages or medical devices.

Foreign investors can establish a foreign-owned company, known as a PT PMA. Depending on the business classification, a PT PMA allows up to 100% foreign ownership.

An import-export company can be 100% owned by foreigners. However, a foreign distributor company can own 67% of shares, whereas a retailer of food and beverage products is fully closed to foreigners.

A PT PMA requires an investment plan of IDR 10 billion (also with a paid-up capital of IDR 10 billion). It takes approximately 1 to 1.5 months to set up a PT PMA.

If You Don’t Want to Establish a PT PMA

Foreign investors who do not want to wait for 1 to 1.5 months to complete the PT PMA registration process can start importing right away with the following alternatives:

Product License Holder

A Product License Holder will provide importers with all necessary licenses. All imported products will be registered based on a license holder agreement without the right of exclusivity. This means that foreign investors can engage several distributors.

Undername Importer

Undername Importer, also known as Importer of Record (IOR), is the ideal solution to import products into Indonesia. An Undername Importer is a registered legal entity with an import license. It is responsible for taking care of all documents and entry requirements to import goods into Indonesia.

What about Halal Certification?

Approximately 88% of the Indonesian population are Muslims. This fact makes Indonesia hold the status of having the world’s largest Muslim population. Taking into account the staggering percentage, investors should care about halal certification.

Starting from October 2019, these product categories are required to have halal certificates from the BPJPH: food and beverages, drugs, traditional medicines and health supplements, cosmetics, chemical, biological, genetically engineered products, and used goods with certain criteria.

Here are the steps to secure a halal certificate:

• Implement Halal Assurance System (HAS) of SNI 99001:2016
• Prepare required documents
• Fill out documents according to certification status and submit them to a representative
• Guidance is provided for all audits and lab analyses by the representative
• A Halal Certificate is issued when the product meets the HAS requirements

According to Indonesian Law No. 6 Year 2023, halal certification is valid as long as there’s no change in the ingredient or process.

How InCorp Indonesia Can Assist

It may be challenging to comply with local regulations regarding import export, company setup, and product registration, especially for foreign investors and during a crisis like COVID-19.

For updates on regulation changes pertaining to the COVID-19 situation and a comprehensive guide to ensure hassle-free importation and product registration in Indonesia, a reliable business consultant like InCorp Indonesia can be a great help.

Learn more about our services and how they can help you by contacting us via the form below.