Indonesia Product Registration & Certification
Important Notes
- BPOM Centralized Regulation & Marketing Authorization: All pharmaceuticals, medical devices, traditional medicines, health supplements, and cosmetics require BPOM approval, following rigorous and lengthy processes.
- Independent Statutory Categories: Traditional Medicines & Health Supplements: Jamu-based Traditional Medicines and modern Health Supplements are distinct registration categories with specific technical and claim requirements.
- Mandatory Local Marketing Authorization Holder: A foreign manufacturer must appoint a locally incorporated company as the MAH, bearing full lifecycle legal responsibility and serving as the sole regulatory contact.
- Absolute Indonesian Language Documentation & Labeling: All technical dossiers, labels, and instructions must be in Indonesian, complying with BPOM’s highly detailed formatting guidelines.
- Critical Market Value of Halal Certification: For food, supplements, and cosmetics, halal certification from MUI, while not a registration mandate, is often crucial for consumer trust and market acceptance.
- Strong Policy Drive for Local Production & R&D: The government strongly incentivizes localization of manufacturing and technology transfer through tax benefits and streamlined registration.
Indonesia Specific Requirements
- World’s Largest Archipelagic Market & Muslim Population: A huge, young, and geographically dispersed population with strong halal consciousness creates a unique, diverse, and massive consumer market.
- Stringent Regulation & Highly Institutionalized Processes: BPOM is known for its rigorous, detail-oriented reviews and complex, lengthy procedures. Attention to detail and local language is paramount, making a professional local partner essential.
- Modernization & Commercialization of Traditional Herbal Culture: The rich Jamu tradition is modernized into a large and trusted Traditional Medicine market through contemporary dosage forms and production.
- Massive Influence of Digital Channels & Social Media: E-commerce and social media KOLs play an increasingly central role in marketing and selling consumer health and beauty products.
- ASEAN Leader & Aspiring Regional Manufacturing Hub: As a core ASEAN economy, Indonesia’s regulatory decisions carry regional weight. It is also actively developing as a regional pharmaceutical and cosmetics manufacturing center.
Medical Devices Registration
Regulatory Requirements
- Medical Device Distribution License (Izin Edar)
- Risk-based classification system (Class A, B, C, D)
- Technical documentation and test reports
- Quality Management System certification (ISO 13485)
- Indonesian language labeling and instructions for use
- Certificate of Free Sale
- Clinical evaluation data
- Biocompatibility testing (where applicable)
- Performance verification reports
- Risk management documentation
Main Process
- Product classification determination
- Technical documentation preparation
- BPOM review submission
- Local importer appointment
- Distribution license acquisition
Registration Timeline
9-18 months
Official Fees
IDR 50,000,000 - 1,500,000,000
Service Fees
$16,000 - $48,000
Regulatory System Overview
BPOM
National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan)
Responsible for medical devices, cosmetics, traditional herbal medicines, pharmaceuticals, and food products registration approvals, quality supervision, and market surveillance. The independent national regulatory authority in Indonesia.
Kemenkes
Ministry of Health of Indonesia (Kementerian Kesehatan)
Responsible for developing national health policies, public health programs, and healthcare standards, working closely with BPOM on regulatory matters.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class A, B, C, D) according to Indonesian regulations
Technical Documentation Preparation
Prepare comprehensive technical documentation in Indonesian language including test reports and clinical data
Local Importer Appointment
Designate authorized importer (Importir Umum) within Indonesia
BPOM Application Submission
Submit Medical Device Distribution License application to BPOM
Technical Assessment Completion
Pass BPOM technical assessment, quality system audit, and product testing
Cosmetic Products Registration
Regulatory Requirements
- Cosmetic Distribution License (Izin Edar)
- Ingredient safety assessment
- Indonesian language labeling requirements
- Good Manufacturing Practices (CPKB)
- Compliance with Indonesian cosmetic regulations
- Product safety documentation
- Microbiological quality specifications
- Stability study data
- Manufacturing process description
- Restricted ingredients compliance
Main Process
- Ingredient compliance assessment
- Safety assessment completion
- Distribution license application
- Label review preparation
- Market access completion
Registration Timeline
6-12 months
Official Fees
IDR 20,000,000 - 500,000,000
Service Fees
$9,000 - $24,000
Regulatory System Overview
BPOM
National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan)
Responsible for medical devices, cosmetics, traditional herbal medicines, pharmaceuticals, and food products registration approvals, quality supervision, and market surveillance. The independent national regulatory authority in Indonesia.
Kemenkes
Ministry of Health of Indonesia (Kementerian Kesehatan)
Responsible for developing national health policies, public health programs, and healthcare standards, working closely with BPOM on regulatory matters.
Cosmetic Products Registration Process
Ingredient Compliance Assessment
Verify ingredient compliance with Indonesian cosmetic regulations and restricted substances list
Safety Assessment Report
Prepare product safety assessment report (CPKB document in Indonesian)
Distribution License Application
Submit Cosmetic Distribution License application to BPOM
Labeling Compliance Review
Ensure labeling compliance with Indonesian language requirements and local regulations
Manufacturer Registration
Complete manufacturer registration with BPOM and GMP compliance
Traditional Herbal Medicines (Jamu) Registration
Regulatory Requirements
- Traditional Herbal Medicine Registration (Izin Edar)
- Ingredient safety and quality evidence
- Indonesian language labeling requirements
- Good Manufacturing Practices (CPOTB)
- Traditional use evidence
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Traditional formulation evidence
Main Process
- Product classification determination
- Technical documentation preparation
- BPOM registration submission
- Label review preparation
- Registration certificate acquisition
Registration Timeline
8-15 months
Official Fees
IDR 30,000,000 - 800,000,000
Service Fees
$12,000 - $32,000
Regulatory System Overview
BPOM
National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan)
Responsible for medical devices, cosmetics, traditional herbal medicines, pharmaceuticals, and food products registration approvals, quality supervision, and market surveillance. The independent national regulatory authority in Indonesia.
Kemenkes
Ministry of Health of Indonesia (Kementerian Kesehatan)
Responsible for developing national health policies, public health programs, and healthcare standards, working closely with BPOM on regulatory matters.
Traditional Herbal Medicines (Jamu) Registration Process
Regulatory Classification
Determine product classification as traditional herbal medicine (Jamu)
Technical Documentation Preparation
Prepare ingredient analysis, traditional use evidence, safety data in Indonesian language
BPOM Registration Application
Submit Traditional Herbal Medicine Registration application to BPOM
Labeling Compliance Review
Ensure labeling compliance with Indonesian traditional herbal medicine labeling regulations
Traditional Evidence Provision
Provide scientific evidence of traditional use and safety data