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Complete Guide to Indonesian AKL (Market Circulation Authorization) Certification

Food/pharmaceuticals/cosmetics/medical devices/food contact materials are essential for market entry in Indonesia

1. Understanding Indonesian AKL Certification

Indonesia's AKL (Izin Edar Angka Klasifikasi Lazim) is a market circulation license number issued by the Indonesian Food and Drug Regulatory Agency (BPOM-Badan Pengawasan Obat dan Makanan). It is a core regulatory certificate under the Indonesian Ministry of Health. All controlled products such as food, drugs, cosmetics, and medical devices sold or imported in Indonesia must obtain a unique number through mandatory AKL certification or filing. Non-compliant products are prohibited from customs clearance, shelving, or promotion. Certification follows the Indonesian Food Law, Drugs and Cosmetics Law, and Medical Device Management Regulations, serving as a mandatory entry certificate for entering the Indonesian consumer market. The certification results are mutually recognized by most ASEAN countries.

1.1 Which products require Indonesian AKL certification?

Category	Specific products
Food category	Processed foods, beverages, nutritional supplements, infant formula, frozen foods, seasonings, prepackaged foods
Pharmaceuticals	Prescription drugs (Rx), over-the-counter drugs (OTC), traditional herbal medicines (Jamu), generics, medicinal health products
Cosmetics	Imported regular cosmetics and special efficacy cosmetics (whitening, spot removal, sun protection, acne treatment, hair growth)
Medical device category	Class I-IV medical devices (medical masks, blood glucose meters, surgical instruments, implantable devices, in vitro diagnostic reagents)
Other categories	Food contact materials (plastic tableware, packaging), disinfectant products, medical dressings, toothpaste, mouthwash, health supplements

Exceptions:

Fresh unprocessed agricultural products (such as vegetables, raw meat, and fresh milk) do not require AKL certification but must pass quarantine by the Indonesian Agricultural Department (Kementerian Pertanian).
Samples intended only for research and testing (not for sale) may apply for a temporary import permit (valid for 6 months).
Locally produced ordinary cosmetics in Indonesia (without functional claims) only require BPOM filing and do not require a full AKL certification process

1.2 Types of Indonesian AKL certification

Types of certification	Applicable products/scenarios	Validity period
AKL Product Registration (Mandatory Certification)	Pharmaceuticals, Class II-IV medical devices, imported cosmetics, special efficacy cosmetics, nutritional supplements	5 years (unified validity period for all categories)
BPOM Notification (Filing)	Local Indonesian general cosmetics, Class I medical devices, food contact materials	Permanently valid (annual information update required)
Registered Importer (Importir Terdaftar)	Local Indonesian entity for all imported BPOM-controlled products	3 years (renewal required 3 months in advance)
Temporary Import Permit (Izin Impor Sementara)	Products for research, emergency medical use, and exhibitions	6 months (non-renewable, can reapply)
Registered Local Manufacturer (Pabrik Lokal Terdaftar)	Food, pharmaceuticals, cosmetics, and medical device companies producing locally in Indonesia	3 years (GMP/SNI audit required)

II. Certification Process & Core Basic Information

Preparation of Materials and Pre-evaluation

Preparation Phase

Confirm product classification (mandatory certification/registration), organize product technical files and safety data, select an Indonesian local agent officially recognized by BPOM (Perwakilan Resmi), and complete product pre-classification review.

Product Testing and Report Acquisition

20-30 working days

Send products to BPOM-recognized laboratories in Indonesia (e.g., Balai Besar POM) to complete safety, efficacy, and quality compliance testing (microbiological, heavy metals, ingredient testing, etc.), and obtain bilingual (Indonesian-English) official test reports.

Online Application Submission

7-15 working days

Submit test reports, product labels, instructions, and other documents through the BPOM official Sistem Informasi BPOM online system and pay certification/registration fees (charged according to product type and classification).

Review and On-site Inspection (if applicable)

25-40 working days

BPOM reviews the completeness and compliance of documents. Drugs, Class III-IV medical devices, and special cosmetics require on-site inspection of the manufacturing facility (meeting GMP/ISO 13485/SNI standards).

Certificate Issuance and AKL Number Acquisition

5-10 working days

After passing the review, obtain the BPOM certification certificate and exclusive AKL number. Product information is entered into the BPOM national database and can be verified online. The AKL number must be permanently displayed prominently on the product packaging.

Core Basic Certification Information

Applicant Information

Business registration certificate of the local Indonesian agent company (TDP/NIB)
Agency Company Tax Registration Certificate (NPWP)
BPOM-approved Agency Authorization Letter (Surat Kuasa, notarized by the Indonesian Embassy)
Indonesian Import License (SIUP Import, if applicable)

Basic Product Information

Complete list of product ingredients/formula (in Indonesian and English, listed in descending order by content)
Product specification sheet, packaging design draft, label sample (including reserved AKL number position)
Bilingual product manual in Indonesian and English (without exaggerated functional claims)
Product classification certification (e.g., medical device grade report, cosmetic efficacy certification)

Testing and Qualification Documents

Comprehensive test report issued by a BPOM-recognized laboratory in Indonesia
Production factory GMP/SNI/ISO 13485 certification (must be officially recognized by BPOM)
Product stability test report (at least 12 months, including accelerated tests)
Raw material supplier qualifications and Indonesian compliance certificates (e.g., halal raw material certificate)

Special Product Registration Documents (classified by product category)

Food Product Registration Documents

Indonesian Halal certification (HALAL) issued by MUI, mandatory
Microbiological test report (total plate count, Salmonella, and other pathogenic bacteria)
Heavy metal/food additive test report (compliant with Indonesian SNI standards)
Nutritional information table (in Indonesian and English, indicating core indicators such as energy, protein, etc.)
Allergen test report and packaging labeling instructions (prominent warnings in Indonesian)
Shelf-life stability test report (at least 6 months, including room temperature/accelerated tests)
Food contact material compliance certificate (packaging materials must comply with BPOM standards in Indonesia)

Cosmetic Product Registration Documents

Complete ingredient list (in descending order by content, with CAS number and Indonesian name for each ingredient)
Product safety assessment report (MSDS, Indonesian version)
Microbiological/heavy metal/methanol test report (compliant with BPOM cosmetic standards)
Functional verification report for special-effect cosmetics (for efficacy such as whitening/sunscreen, third-party testing required)
Product stability test report (12 months, including high/low temperature/cycle testing)
Declaration of absence of prohibited ingredients (such as corticosteroids, mercury, lead, and other BPOM forbidden ingredients)
Production equipment cleaning validation report (to ensure no cross-contamination of raw materials)

Registration information for medical device products

Medical device classification certificate (Class I-IV classification report issued by BPOM accredited body)
Complete product technical documentation (design, production, performance parameters, inspection standards)
Product Risk Analysis Report (compliant with ISO 14971 standard, Indonesian version)
Biocompatibility test report (required for implantable/skin-contact devices)
ISO 13485 Quality Management System Certification (requires official BPOM mutual recognition)
Clinical evaluation report (Essential for Class II-IV devices, including clinical data/literature support)
Product sterilization verification report (disposable medical devices must provide ethylene oxide/irradiation sterilization certificate)

3. Indonesian AKL certification label requirements

General requirements

It must be annotatedIndonesian EnglishBilingual instructions: Indonesian fonts are no smaller than English and take up the main page
Clearly display Indonesian BPOM-AKL serial numbers (standard format: BPOM RI AKL XXXXXXXX)
Include the full name of the manufacturer, address, and the full contact information of the local Indonesian agent (phone/address)
Production date, expiration date (standard format: DD-MM-YYYY) and production batch number (Batch No.)
Product ingredients/formula (listed in descending order of content, core ingredients labeled in Indonesian)
Food/cosmetics must bear the Indonesian Halal Certification (HALAL) mark (issued by MUI)

Special restrictions

Food: Claims such as "cure," "cure," or "medical efficacy" are prohibited; only nutrition-related benefits may be labeled
Cosmetics: Special efficacy products must be labeled as "BPOM Diizinkan untuk Khasiat XXXX" and the target group; exaggeration of efficacy is prohibited
Medications: Prescription/OTC labeling (Rx/OTC) must be indicated, clearly indicating usage, dosage, contraindications, and storage conditions
Medical devices: must be marked with classification labels (Kelas I/II/III/IV) and use warning phrases (e.g., "Hanya untuk Penggunaan Medis")
All products: The use of official logos such as the Indonesian flag and emblem is prohibited, and false origin claims are prohibited

Format and violation explanations

Format standardized
The AKL number must be printed prominently on the front or back of the packaging (font ≥ 12, unobstructed). The label must be waterproof, abrasion-resistant, and resistant to storage environments; Pharmaceutical/medical device labels must clearly indicate storage conditions (e.g., "Di bawah 25°C, Hindari Cahaya Langsung"); Imported products must affix the Indonesian main label, but must not overwrite core certification information such as AKL number or halal marking
Violation penalties
Missing labels/incorrect information: maximum fine of 500 million rupiah (about 230,000 RMB), forced removal and recall of products; Misuse/forgery of AKL numbers: 1-7 years imprisonment, fines of 1-5 billion rupiah, and permanent inclusion of related companies on BPOM blacklist; Mandatory sales of products without AKL certification: confiscation of all inventory, fines of five times the product value, and cancellation of import qualifications by importers;

Calculate the compliance path for Indonesia AKL certification clearly

Materials, duration, and costs explained at once; if not approved, compensation as agreed.

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Indonesia AKL Certification