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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.

Services We Offer
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



Each category falls under a specific platform and licensing model:
Regulatory Authority | Regulates | Platform |
---|---|---|
BPOM | Pharmaceuticals, cosmetics, processed food, supplements, herbal | e-BPOM, e-Registration |
Ministry of Health (MoH) | Medical devices, diagnostics, hospital-use products | OSS (Online Single Submission) |
BKPM / OSS-RBA | Business licenses, National Institute of Biologics, risk-based categorization | https://oss.go.id |
Product Categories Regulated in Indonesia
Category | Examples |
---|---|
Pharmaceuticals | Prescription drugs, generics, biologics, OTC |
Medical Devices | Diagnostic kits, instruments, implants |
Cosmetics | Skin, body, and hair care products, fragrances |
Health Supplements | Vitamins, minerals, nutraceuticals |
Traditional Medicine | Herbal formulations, Jamu, Ayurveda-inspired products |
Processed Foods | Beverages, snacks, packaged products |
Risk-Based Classification and their Registration Routes
Risk Level | Products | Registration Route Type |
---|---|---|
High Risk | Prescription drugs, implants | Full Evaluation |
Medium Risk | Supplements, diagnostic kits | Abridged Review |
Low Risk | Cosmetics, general food products | Notification |
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
Category | Timeline (approx.) |
---|---|
Cosmetics & Food | 2–4 months (notification route) |
Health Supplements | 4–6 months (abridged review) |
Medical Devices | 3–6 months (based on device class) |
Pharmaceuticals | 9–12 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.





FAQs
Can a foreign company register products without a local presence?
Is Halal certification required for all products?
How long is a marketing authorization valid in Indonesia?
Are there separate fees for variation filings and renewals?
- IDR 5,000,000 for branded drugs
- IDR 1,000,000 for generic drugs
What are the typical fees for drug registration in Indonesia?
Looking to Register Your Product in Indonesia?
Still Have Questions ?
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