registrasi produk

Sistem Registrasi Produk dan Regulasi Produk di Indonesia

  • InCorp Editorial Team
  • 18 Juni 2024
  • 6 minute reading time

If you’re looking to navigate the complexities of product registration in Indonesia, you’ve come to the right place. This comprehensive guide will provide insights and information on product registration in Jakarta and other cities across Indonesia. We focus on four key imported product categories: Medical Devices, Cosmetics/Beauty, Food Supplements, and Food and Beverage.

Overview of Indonesia’s Product Industry

Indonesia, with a population exceeding 270 million, witnessed a significant economic milestone when it transitioned to an ‘upper-middle-income country’ status in July 2020, as declared by the World Bank. This transformation is attributed mainly to Indonesia’s growing middle class. 

The new status is resulting in increased consumption rates and diverse market demands. The Indonesian government’s efforts to simplify regulations for foreign investments and the rapid adoption of digital technologies further. They plan to contribute to the nation’s attractiveness to foreign companies and investors.

Understanding BPOM Indonesia and Its Regulatory Role

In essence, Badan Pengawas Obat dan Makanan (BPOM) is Indonesia’s equivalent of the Food and Drug Administration (FDA). BPOM regulates and oversees national policies, standards, and regulations governing various products, including food, beverages, medicines, medical devices, health supplements, and cosmetics imported, distributed, and sold in Indonesia.

In summary, here are the key functions of BPOM:

  • Formulating new policies, standards, procedures, and criteria.
  • Updating existing policies, standards, procedures, and measures.
  • Implementing and supervising enforcing policies, standards, practices, and actions.
  • Conducting laboratory testing of products.
  • Inspecting manufacturing, distribution facilities, and product sampling.
  • Issuing certificates and permits.

Quality Standards for Indonesia Products

Indonesia’s pursuit of economic growth prioritizes foreign direct investment and international collaboration to establish global standards for product registration in Jakarta and Indonesia. Essential quality standards include:

  • 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)

Product Registration via BPOM – Basic Requirements

Registering products in Food and Beverage, Medical Devices, Health Supplements, and Cosmetics in Indonesia follows a 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 for more details.

BPOM Indonesia Food Regulation and Registration

Food and beverage products are categorized based on risk levels, which are divided into four categories. The risk level depends on factors such as food additives and statement claims.

  • Very Low Risk: Minimal processing, few ingredients.
  • Low Risk: Processed products like instant noodles.
  • Medium Risk: Mainly processed foods with sterilization or pasteurization.
  • High Risk: Products tailored for specific health conditions.

Consult our experts for specific details regarding risk classification and registration procedures.

How Indonesia Enforces Control on Medicines and Food through BPOM?

The Indonesian government, through the Food and Drug Supervisory Agency (BPOM), mandates the registration of all local and imported products before distribution. To expedite the process, exporters are advised to engage a local business partner and allocate sufficient time for BPOM registration.

Products registered with the Directorate of Food Safety Assessment receive unique labels:

  • Code ML (Imported Food): Applied to imported processed food and beverages.
  • Code MD (Domestically Produced Food): Issued to large-scale domestic products meeting government food safety requirements.
  • Code SP (Counselling Certificate): Granted to small and medium enterprises receiving counseling.

BPOM’s labeling procedure adheres to regulations (No. 27/2018 and No. 26/2018) overseeing food and drug entry and e-licensing. Required documents include an application letter, Importer’s Permit, Authorization Letter, Certificate of Good Manufacturing Practice (GMP), Trading License copy, Taxpayer Identification Number (NPWP) copy, and an Industrial License for pharmaceutical products, along with any additional necessary documents.

Types of Product Registration in Indonesia

Health Supplements Product Registration in Indonesia

Health supplements in Indonesia supplement nutritional needs and improve health function, containing vitamins, minerals, amino acids, and other materials. Health supplements are categorized into three types based on ingredients and preparation form.

  • Category 1: Contains isolated materials.
  • Category 2: Includes natural materials.
  • Category 3: Involves new preparation forms, dosages, and usages.

Registration procedures for health supplements mirror those for food and beverages, ensuring safe and compliant products.

Medical Devices and Equipment Product Registration in Indonesia

Medical devices are categorized into four classes based on their potential impact on health. The registration process is as follows:

  • Register the legal entity at the Ministry of Health online.
  • Inspect local manufacturers (if applicable).
  • Register products after class determination, allowing distribution and sale.

BPOM Indonesia Cosmetic Product Registration

Cosmetic products in Indonesia require registration for each product variation—strict regulations about labeling, advertising, claim requirements, and ingredient usage. Ensure compliance with these requirements for successful registration.

  • Register the legal entity online at BPOM.
  • Online registration of the manufacturer.
  • Register products, enabling distribution and sale.

Guide to Doing Business in Jakarta

Mailchimp Free eBook Indonesia Business Insight

How to Register Your Product through BPOM?

To bring medicines, traditional cures, cosmetics, food supplements, and processed foods into Indonesia, comply with the safety standards set by the Indonesian National Agency of Drug and Food Control (BPOM). The process, governed by Regulation No. 12 of 2015, mandates registration before customs clearance.

Follow these steps to obtain a Letter of Import (SKI) from the Head of BPOM:

Register online at BPOM’s or INSW’s website using Single SignOn.

Upload required documents:

  • Application letter
  • Letter of responsibility
  • Importer Identification Number (API) – NIB
  • Trading Business License (SIUP)
  • Tax ID (NPWP)
  • Power of attorney letter for importing
  • List of HS code for the product
  • For drug SKI, include the Pharmaceutical Industry License.

Complete e-payment as Non-Tax Revenue (PNBP)

Submit electronic documents:

  • Distribution approval license
  • Certificate of analysis
  • Invoice
  • Proof of Payment of Non-Tax Revenue (PNBP).
  • For vaccine and serum applications, include: Batch/lot release certificate and summary of batch/lot protocol
  • Certificate of analysis
  • Letter from the producer.
  • For processed food, a letter of recommendation may be required. Additional documents may be requested based on the product category.

Streamline Your Indonesia Product Registration with InCorp

Navigating product registration in Indonesia can be challenging and risky when done independently. InCorp Indonesia (formerly Cekindo) is your expert guide through this intricate process, ensuring you meet Indonesian regulations. We will help you with:

  • Complex Regulations: We handle the complicated rules for imported products.
  • Company Setup: Establishing the proper structure for product imports.
  • Document Accuracy: We ensure your paperwork is complete and accurate, speeding up approvals.

Contact our product specialists by filling out the form below to simplify your product registration for a successful entry into the Indonesian market.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

Get in touch with us.

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Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.

We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.

We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.

Frequent Asked Questions

  • Kategori A (Risiko rendah): Jika salah digunakan, alat kesehatan tidak menyebabkan bahaya kepada manusia.
  • Ketegori B (resiko rendah ke sedang): Jika salah digunakan, alat kesehatan mungkin saja menyebabkan dampak serius, namun tak dianggap sebagai kecelakaan berat.
  • Ketegori C (risiko sedang): Jika salah digunakan, alat kesehatan mungkin saja menyebabkan dampak yang sangat serius, namun tetap belum dianggap sebagai kecelakaan berat.
  • Kategori D (risiko tinggi): Jika salah digunakan, alat kesehatan mungkin menyebabkan dampak yang berbahaya, dan dianggap sebagai kecelakaan fatal terhadap manusia.

Bisa. Anda dapat mengimpor produk melalui layanan Importer of Record yang memungkinkan perusahaan mengimpor barang melalui perantara mitra importir.

Sebelum didistribusikan, Anda harus mendaftarkan produk tersebut ke Badan Pengawas Obat dan Makanan (BPOM). Hanya badan hukum di Indonesia saja yang dapat mendaftarkan produk ke BPOM. Jika Anda memutuskan untuk mendistribusikan produk melalui distributor lokal, mereka akan mendaftarkan produk Anda dengan nama mereka, dan menjadi pemegang izin produk. InCorp bisa menjadi mitra distributor lokal dan mendaftarkan produk Anda.