Panduan 2020 tentang Impor Makanan, Minuman dan Alat Kesehatan serta Sertifikasi Halal

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.

Product Registration Halal

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.

Update Lebih Lanjut tentang Prosedur Sertifikasi Halal di Indonesia

Memperbarui diri sendiri dengan regulasi terkini di Indonesia penting untuk menjalankan bisnis yang berkelanjutan. Terkait sertifikasi halal di Indonesia, pada 15 Oktober 2019 Kementerian Agama membuat efektif Peraturan 26/2019 tentang Badan Penjamin Produk Halal.

Cekindo telah memilih beberapa area terpenting untuk Anda ketahui:

  • Implementasi sertifikasi halal progresif
  • Prosedur sertifikasi halal
  • Pelabelan halal

Implementasi Sertifikasi Halal Progresif

Wajib bagi semua barang dan jasa yang diimpor dan diperdagangkan di wilayah Indonesia untuk memiliki sertifikasi halal. Namun, produk dari bahan non halal tidak diwajibkan memiliki sertifikasi halal.

Bisnis dapat memperoleh sertifikat halal secara progresif atau perlahan dalam periode yang ditentukan berikut:

  • Makanan dan minuman: 17 Oktober 2019 – 17 Oktober 2024
  • Pengemasan makanan dan minuman: tergantung pada jenis makanan dan minuman
  • Obat tradisional dan suplemen kesehatan: 17 Oktober 2021 – 17 Oktober 2026
  • Pakaian, aksesoris kepala dan aksesoris: 17 Oktober 2021 – 17 Oktober 2026
  • Produk kimia, produk kosmetik dan produk rekayasa: 17 Oktober 2021 – 17 Oktober 2026
  • Alat kesehatan risiko kelas A: 17 Oktober 2021 – 17 Oktober 2026
  • Peralatan rumah tangga, pasokan produk rumah tangga, alat tulis dan peralatan kantor, peralatan doa umat Muslim: 17 Oktober 2021 – 17 Oktober 2026
  • Alat kesehatan risiko kelas B: 17 Oktober 2021 – 17 Oktober 2029
  • Obat Over-the-counter (OTC) dan obat OTC terbatas: 17 Oktober 2021 – 17 Oktober 2029
  • Alat kesehatan risiko kelas C: 17 Oktober 2021 – 17 Oktober 2034
  • Obat-obatan yang diresepkan (kecuali psikotropika): 17 Oktober 2021 – 17 Oktober 2034
  • Layanan terkait obat OTC, obat OTC terbatas, obat yang diresepkan (kecuali psikotropika), produk kimia, kosmetik dan produk rekayasa: tergantung jenis produk
  • Produk biologis, produk obat, alat kesehatan dengan bahan atau proses produksi yang belum ditentukan sebagai halal: sesuai hukum dan regulasi terkait

 

Produk yang tidak memiliki sertifikat halal sebelum 17 Oktober 2019 masih dapat diimpor dan diperdagangkan di Indonesia mengacu pada periode di atas.

Selain itu, selain makanan dan minuman, bisnis tidak diizinkan menyampaikan aplikasi sertifikasi halal sebelum periode di atas dimulai.

Prosedur Sertifikasi Halal

Semua bisnis harus mengikuti prosedur berikut untuk memperoleh sertifikat halal:

  1. Sampaikan dokumen ke Badan Penyelenggara Jaminan Produk Halal (BPJPH) dan BPJPH akan memeriksa dokumen dalam 10 hari kerja.
  2. Begitu dokumen dikonfirmasi lengkap, Lembaga Pemeriksa Halal (LPH) akan menguji jika produk halal, memvalidasi dokumen dan proses manufaktur.
  3. LPH lalu akan melapor hasil pengujian ke BPJPH. Begitu laporan dinyatakan lengkap, BPJPH akan menyampaikan ke Majelis Ulama Indonesia (MUI).
  4. MUI menentukan jika produk halal melalui halal fatwa. Keputusan akan disampaikan ke BPJPH.
  5. BPJPH akan menerbitkan sertifikasi halal setelah persetujuan.

Pelabelan Halal

Label halal di produk wajib hukumnya saat bisnis telah memiliki sertifikasi halal yang sesuai.

Format baru pelabelan halal ditentukan BPJPH dalam Peraturan 26/2019 dan format pelabelan halal sebelumnya masih dapat digunakan hingga 15 Oktober 2024.

Bagaimana Cekindo dapat Membantu

Cekindo adalah perusahaan konsultasi bisnis dengan rekam jejak kesuksesan yang tinggi menyangkut kepuasan pelanggan dan penyampaian layanan. Kami menawarkan layanan dan bantuan konsultasi untuk memperoleh sertifikat halal di Indonesia.

Pertama, kami akan memahami perusahaan Anda beserta produk dan layanannya, lalu kami akan memroses dengan analisis celah untuk mengidentifikasi masalah yang Anda hadapi saat memroses sertifikasi halal.

Kami juga akan membantu dengan persiapan dokumen dan penyampaian aplikasi sesuai persyaratan BPJPH. Ini mengeliminasi waktu dan upaya yang Anda kerahkan sehingga sertifikat halal bisa sampai ke tangan Anda lebih cepat dan efektif.

Tertarik memiliki sertifikat halal untuk produk Anda dan melakukan ekspansi bisnis? Silakan tanya apa saja pada kami tentang regulasi sertifikasi halal baru, dan ahli kami siap membantu.

Isi form di bawah ini.

Industri Halal: Masa Depan Perekonomian Indonesia – Dapatkan Sertifikasi Halal Sekarang

No one would argue the fact that Indonesia has the largest Muslim population in the world. Consisting of over 260 million people, Indonesia has more than 88% Muslim citizens.

According to a study conducted by Thomson Reuters, in 2015 alone, Muslims worldwide spent over US$1.9 trillion in a variety of sectors, especially in the food and beverages and clothing industries. In 2016, Indonesia was ranked the country with the highest spending on food and beverages, amounting to US$169.7 billion.

Therefore, Indonesia is favorably positioned to be Southeast Asia’s biggest halal products hub. This is very attractive to many foreign investors. The projection is further supported and evidenced by the diverse Indonesian demographics, increasing consumer awareness, growing income, and rising awareness of religious obligations.

Let us take a closer look at the halal industry in Indonesia and how ready the initiative is to drive and shape the future of Indonesia’s economy.

The Halal Industry in Indonesia is Booming

In 2018, the Indonesian government revealed that halal certification would be mandatory by 2019. This makes sense because Indonesia wishes to push the already booming halal industry and lead the country to become a global halal hub.

Plus, the Indonesian Halal market has yet to reach its full potential. Many opportunities are on their way to benefit the investors, business owners, and the country’s economy.

Furthermore, the global Muslim population will increase to 2.2 billion by 2030, and the Indonesian population contributes to a big part of the increase. Within eight years’ time, from 2010-2018, the Muslim population in Indonesia reached 200 million people, and the number has never stopped growing.

With all the stated facts, the demand for halal products is believed to rise significantly. Numerous small and medium-sized companies in Indonesia have already taken advantage of these halal opportunities.

halal market indonesia

Big Business in Halal

A result from Google Trends shows the search for halal topics has increased greatly, indicating that people have increased interest in halal products and services.

With a market value of more than US$1 trillion and estimated to reach US$2.6 trillion by 2023, the Indonesian government has strongly encouraged industry players to enter this highly profitable market.

You may wonder which sectors have the most considerable potential and profits in the halal market. According to a report by Indonesia Halal Lifestyle Center (IHLC), ten sectors are currently thriving as major halal businesses: food, fashion, education, pharmaceuticals, cosmetics, tourism, media and travel, medical and health, art and culture, and Sharia financial and banking industry.

Related article: Most Common Questions about Halal Certificate

Mandatory Halal Certification in Indonesia

Taking effect from October 2019, all businesses are required to obtain the mandatory halal certification. This new regulation will also enforce labeling and quality measures for halal products. Halal certificates are issued by the Halal Products Certification Agency (Badan Penyelenggara Jaminan Produk (BPJPH)).

Only businesses with halal certification will be able to prove that their halal products comply with Sharia laws, thus permitting the products to be consumed or used. This new law includes goods and services related to food and beverages, cosmetics, pharmaceuticals, chemical and biological products, and genetically modified products.

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

Process of Halal Certification in Indonesia

Though the halal certification process might seem cumbersome, InCorp Indonesia can simplify the process for you. With InCorp Indonesia, the process to apply for halal certification in Indonesia is as follows:

  • Meet MS23000 halal requirements and implement the Halal Assurance System (HAS)
  • Prepare all necessary documents, the registration, and the halal certification contract fee, and submit them to InCorp Indonesia
  • Fill out documents according to your certification status and submit them to us to be processed
  • To ensure compliance, guidance is provided for all audits and lab analysis
  • The certificate is issued when the product meets HAS requirements and passes lab analysis.

Read also our in-depth guide on Securing Halal Certification in Indonesia.

Certify Your Halal Products through InCorp Indonesia

One important point to note is that if you do not obtain halal certification for your products in Indonesia, even when they are halal, they will become non-halal, with gradual implementation starting in October 2019.

This is why we urge you to register your halal products and obtain halal certificates as soon as possible. Get in touch with us today should you require assistance with your halal certification application in Indonesia by filling in the form below. Or visit our offices in Jakarta, Bali, Semarang, Surabaya, and Batam.