Lifesciences Compliance Services in Indonesia

Expert consulting for life sciences firms navigating regulatory compliance, BPOM submissions, and approval processes in Indonesia.

Indonesia

BPOM Approval and Product Licensing Guidance

We provide integrated services in the major life sciences industries. As a leading company, Artixio offers our clients to make use of our comprehensive services which include regulatory, market research & access, product lifecycle, testing, pharmacovigilance and more. Join us for ongoing support, customized strategies and faster product approvals.

Regulatory Authority in Indonesia

In Indonesia, the National Agency for Food and Drugs Control (BPOM) is responsible for the drugs and food supervision. The Ministry of Health, Indonesia, is authorized for the medical device regulation. A product license is required for the marketing of pharmaceuticals as well as medical devices. At times it can be confusing to understand which regulations apply in different situations. For instance, in Indonesia, the medical devices are divided into 4 classes. Ranging from low risk to high risk and the requirements are different for each class.

Regulatory Submission and Documentation Support Services In Indonesia

Our team has hands-on experience supporting regulatory requirements in Indonesia. With deep knowledge of local processes and a practical approach, we help clients navigate submissions, testing, approvals, and ongoing compliance with confidence. Whether it’s product registration, post-approval changes, or market access, we work closely with you at every stage — including document preparation, quality support, and lifecycle management.

We aim to support life sciences companies in bringing safe, high-quality products to global markets. Our work spans across key sectors including pharmaceuticals, medical devices, cosmetics, nutrition, biologics, and animal health. At Artixio, we focus on practical, reliable solutions that help you meet regulatory expectations and reach customers faster.

Artixio: Leading Your Way

Artixio operates in Indonesia through strong regional presence and affiliate networks. This was possible for us through our decades of experience, excellence, flexible and creative attitude in delivering the client needs.

We believe innovation doesn’t happen without genuine interest. Like our clients, we care deeply about bringing meaningful products to market — whether they help treat serious conditions or simply improve everyday life. While the industry often leans toward business goals, we stay focused on making sure only safe, effective, and quality products reach the public.

What sets us apart is the kind of guidance we offer throughout each regulatory step. From identifying gaps to helping accelerate approvals, we adapt our support based on what each product needs. Our understanding of regional rules and market realities helps prevent delays, rejections, or recalls. Big or small, every project matters to us — and we put everything into getting it right for our clients.

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Why Artixio For Regulatory Compliance Services in Indonesia?

FAQs

Which CTD format is used in Indonesia?

ASEAN Common Technical Dossier (ACTD) is the CTD format used in Indonesia. Unlike eCTD, ACTD has 4 parts. Part I contains table of contents, administrative and prescribing information, Part II should contain quality overall summary and body of data, Part III must have non-clinical overview summary and study reports and lastly Part IV describe clinical overview summary and study reports.

What are the steps involved in the registration for a BPOM Certificate in Indonesia?

Completion of BPOM registration form, preparation of relevant documents according to the type of BPOM Certificate applying for. For cosmetic products submit the documents to NADFC and for food products submit to the BPOM officer. Assessment and evaluation is carried out to ensure product fitness in the Indonesian market. After this, wait for the review of the application. If approved your account will be active.

What products require a BPOM Certificate in Indonesia?

The products include therapeutic products, drug ingredients, narcotics, psychotropics, additive substances, precursor, cosmetics, health supplements and complementary products, processed foods and traditional medicines

What is Izin Edar?

Izin Edar is the distribution permit. Besides from the BPOM certificate, to distribute the product in the market this distribution permit is required.

What is the validity period for marketing authorization for products in Indonesia?

5 years is the marketing authorization validity for products including pharmaceuticals and medical devices in Indonesia. It can be extended via the renewal registration mechanism. The marketing authorization can expire and must be renewed before the date of expiration.

Lifesciences Compliance Services in Indonesia

Indonesia

Our Services

Our Countries

Our Industries

BPOM Approval and Product Licensing Guidance

Regulatory Authority in Indonesia

Regulatory Submission and Documentation Support Services In Indonesia

Artixio: Leading Your Way

Our Services

Why Artixio For Regulatory Compliance Services in Indonesia?

FAQs

Which CTD format is used in Indonesia?

What are the steps involved in the registration for a BPOM Certificate in Indonesia?

What products require a BPOM Certificate in Indonesia?

What is Izin Edar?

What is the validity period for marketing authorization for products in Indonesia?

Industries We Serve in the Indonesia

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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