Regulatory Affairs Consulting Services 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.

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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 Regulatory Authorities 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) – Online Single Submission Risk-Based Approach – Handles business licensing, risk-based categorization, and National Business Identification Number (NIB).

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 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 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

Registration and approval timelines depend on risk classification, product type, and dossier completeness.

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?

No, Indonesian law mandates a local entity or MAH to manage submissions, approvals, and renewals.

Is Halal certification required for all products?

No, it’s not mandatory across all sectors, but highly recommended for food, cosmetics, and supplements to meet consumer demand and distribution requirements.

How long is a marketing authorization valid in Indonesia?

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.

Are there separate fees for variation filings and renewals?

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

What are the typical fees for drug registration in Indonesia?

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.

Looking to Register Your Product in Indonesia?

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.