Artixio

Regulatory Affairs Consultant in Indonesia

Regulatory Affairs services in Indonesia offering expert strategies and lifecycle product maintenance support for efficient product registrations and sustainable compliance across all regulated sectors.

Did you know that documentation errors and regulatory misclassification are among the top reasons for product approval delays in Indonesia?

With a population of over 270 million, Indonesia is one of Southeast Asia’s largest healthcare markets. However, its regulatory system can be challenging due to multiple authorities, local language dossier requirements, and a changing risk-based approach. Partnering with experts offering regulatory compliance services in Indonesia can help simplify the process and reduce approval delays.

Key authorities to manage regulatory compliance in Indonesia

BPOM (Badan Pengawas Obat dan Makanan) – Indonesia’s National Agency of Drug and Food Control, regulating drugs, cosmetics, supplements, and processed foods.
Ministry of Health (MoH) – Responsible for medical devices, diagnostics, and hospital-use equipment.
OSS-RBA (BKPM) – Handles business licensing, risk-based categorization, and National Business Identification Number (NIB).

Each category falls under a specific platform and licensing model:

Regulatory AuthorityRegulatesPlatform
BPOMPharmaceuticals, cosmetics, processed food, supplements, herbale-BPOM, e-Registration
Ministry of Health (MoH)Medical devices, diagnostics, hospital-use productsOSS (Online Single Submission)
BKPM / OSS-RBABusiness licenses, National Institute of Biologics, risk-based categorizationhttps://oss.go.id

Product Categories Regulated in Indonesia

CategoryExamples
PharmaceuticalsPrescription drugs, generics, biologics, OTC
Medical DevicesDiagnostic kits, instruments, implants
CosmeticsSkin, body, and hair care products, fragrances
Health SupplementsVitamins, minerals, nutraceuticals
Traditional MedicineHerbal formulations, Jamu, Ayurveda-inspired products
Processed FoodsBeverages, snacks, packaged products

Risk-Based Classification and their Registration Routes

Indonesia adopts a risk-based classification system to determine the regulatory route, required documentation, and review timelines. Each category requires a customised approach and specific documentation.
Risk LevelProductsRegistration Route Type
High RiskPrescription drugs, implantsFull Evaluation
Medium RiskSupplements, diagnostic kitsAbridged Review
Low RiskCosmetics, general food productsNotification

Regulatory Affairs Lifecycle in Indonesia

Every step of the product registration process is handled by Artixio’s regulatory consultants, backed by our proprietary intelligence system. The product follows a BPOM-compliant process for approval and licensing, which can vary in complexity based on the risk level and product classification. Our Indonesia regulatory affairs consulting services help streamline this journey and reduce delays.

Estimated Registration Timelines

Registration and approval timelines depend on risk classification, product type, and dossier completeness.
CategoryTimeline (approx.)
Cosmetics & Food2–4 months (notification route)
Health Supplements4–6 months (abridged review)
Medical Devices3–6 months (based on device class)
Pharmaceuticals9–12 months (full evaluation)

Why Artixio?

Artixio combines global standards with in-country execution to support effective regulatory affairs in Indonesia, helping clients manage compliance and approvals with confidence.

35+ years of ASEAN regulatory experience
Full regulatory lifecycle maintenance
ACTD, CTD, and BPOM-standard dossier preparation
Local submission & MAH representation
Digital platform expertise across e-BPOM and OSS

FAQs

Can a foreign company register products without a local presence?
No, Indonesian law mandates a local entity or MAH to manage submissions, approvals, and renewals.
No, it’s not mandatory across all sectors, but highly recommended for food, cosmetics, and supplements to meet consumer demand and distribution requirements.
A drug’s marketing authorization is valid for 5 years. Renewal applications must be submitted no sooner than 12 months and no later than 2 months before the license expiry date to avoid lapse.
Yes. Variations that involve changes to manufacturing sites, active ingredients, or labeling—especially those affecting safety—can cost between IDR 1,000,000 to 12,500,000. Renewal of marketing authorizations costs:
  • IDR 5,000,000 for branded drugs
  • IDR 1,000,000 for generic drugs
Drug registration fees in Indonesia vary significantly based on the product type and level of regulatory evaluation required. For example:
  • Pre-registration: IDR 1,000,000 per item
  • New active substances or new combinations: IDR 30,000,000
  • Generic drugs: between IDR 2,000,000 and IDR 12,500,000
  • These fees are governed by Government Regulation No. 32 of 2017 and are payable to BPOM.
  • Regulatory processes can feel complex but we, at Artixio help you to reduce regulatory risks, accelerate approvals, and stay compliant. With deep regional expertise and tech-enabled processes, we simplify compliance, reduce regulatory risks, and accelerate product approvals with flexible, budget friendly and timely compliance solutions.
    Talk to our regional regulatory expert today to make your product approvals faster, easier, and fully compliant.

    Still Have Questions ?

    Get expert answers tailored to your needs.

    Specialized Regulatory Affairs
    Services Across Multiple Industries

    Pharmaceuticals

    MedTech

    Cosmetics

    Nutrition

    Biologics

    Veterinary

    Expert Regulatory Services To Streamline Compliance

    Regulatory Intelligence & Strategy
    Medical & Technical Writing
    Publishing & Submission
    Product Registration
    Investigation New Drug Application (IND)
    New Drug Application (NDA)
    Post Approval Lifecycle Maintenance
    Artwork and Label Review
    Ad Promo Review

    Regulatory Affairs Across Multiple Countries

    India

    Singapore

    Mexico

    Brazil

    Vietnam

    Malaysia

    Argentina

    Colombia

    Taiwan

    China

    European

    Thailand

    Indonesia

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