Medical Device Registration in Indonesia

Streamline your Indonesia medical device registration process with our full regulatory support from dossier preparation and Regalkes submission to license holding and post-approval compliance.

At Product Registration Indonesia, we simplify the medical device registration process so you can focus on bringing your products to market efficiently and confidently.

Dr. Hussein H. Mashhour, MD, has more than 10 years of experience in product registration and licensing in Indonesia.

Why Choose Us for Medical Device Registration in Indonesia?

Indonesia’s growing healthcare market presents tremendous opportunities for medical device manufacturers. Product Registration Indonesia helps foreign manufacturers and local distributors navigate Indonesia’s Ministry of Health (MoH) Regalkes system for medical device registration and licensing.

With over 15 years of experience, our regulatory consultants ensure your submission is accurate, fast, and compliant by minimizing costly delays or rejections.

End-to-end support for Regalkes and IDAK (Distributor License)
CDAKB (Good Distribution Practice) certification readiness
Preparation and review of complete technical dossiers
Representation as neutral license holder for flexibility in distributor management
Support for foreign principals in all classes of medical devices (A–D) and IVD

Our Medical Device Registration Service

Regulatory Consultation

Our experts assess your medical device classification (Class A to D) and provide a clear roadmap for compliance, minimizing potential delays.

Document Preparation

We handle all required administrative and technical documentation, including:

• Company Registration (NIB)

• Good Manufacturing Practice (GMP) Certificate

• Distributor License (IDAK) & Good Distribution Practice (CDAKB)

• Executive Summaries, Device Descriptions, Risk Analysis, and Validation Reports

Submission and Monitoring

We manage the entire submission process through the MOH’s e-registration system, ensuring timely progress updates.

Post-Approval Support

Product Registration Indonesia provide ongoing support to maintain compliance:

Post-market surveillance & vigilance reporting
Renewal & license transfer support
Regulatory updates as Indonesia’s medical device regulations evolve

Partner with Product registration indonesia

Deep Regulatory Knowledge

Our experts stay up to date with the latest MOH and ASEAN directives, ensuring a smooth and compliant medical device registration process.

Local Expertise

Partner with us to benefit from our local connections and in-depth understanding of the Indonesian regulatory landscape.

Tailored Solutions

Whether you need to register a simple Class A product or a high-risk Class D device, our services are customized to meet your specific needs.

Benefits of Our Services

Fast Approval Times

With our streamlined document preparation and submission process, we help you bring your medical devices to market sooner.

Risk Mitigation

Our local expertise ensures that you avoid costly mistakes and regulatory hurdles, giving you peace of mind.

End-to-End Compliance

From registration to post-approval maintenance, we cover every aspect of regulatory compliance, saving you time and effort.

Get Started Today

Ready to simplify your medical device registration process in Indonesia? Contact us now for a free consultation, and let our experts guide you every step of the way. Don’t let regulatory challenges delay your market entry—act now and secure your success.

Clients Testimonial

See what our clients are saying

"The Product Registration Indonesia team was highly professional in helping us secure Medical Device Registration for our Class B diagnostic equipment. The process was transparent, the timeline well managed, and they were always responsive whenever we needed document updates."

Dr. Emily Clarke

Regulatory Affairs, Indonesia

"Our Cosmetic Product Registration went smoothly thanks to their expert team who thoroughly understand the latest BPOM regulations. They explained each technical requirement clearly, allowing us to launch our skincare line on schedule."

Nguyễn Thị Lan

Quality Assurance at Beauty & Wellness Company, Vietnam

"Used their Undername Export/Import service to ship our herbal supplements to Indonesia. All customs procedures and licensing were handled in detail, enabling us to enter the market without a local entity."

Rajesh Kumar

Entrepreneur, India

The Household Product Registration for our eco-friendly cleaning range went off without a hitch. Their team conducted an initial product assessment and provided formulation recommendations to meet BPOM standards.

Jessica Lee

Product Manager at Retail Company, Singapore

"Their Medical Device Registration for our surgical instruments was extremely thorough. From risk classification to documentation verification, everything was handled according to international standards."

Lim Soo-jin

Compliance Manager at Healthcare Company, South Korea

The Food and Beverage Registration for our chili sauce was surprisingly easy, thanks to the Product Registration Indonesia service. They provided comprehensive guidance for the license submission.

Siti Nurhayati

Brand Manager at FMCG Company, Indonesia

Frequently Asked Questions (FAQ)

Why should I register a medical device in Indonesia beyond just meeting government rules?

Registering a medical device in Indonesia is not only a legal requirement (you must hold a Nomor Izin Edar / NIE to import, sell, or distribute). It’s a strategic business move that affects market control, timing, and commercial opportunity.

Medical device registration in Indonesia as a commercial strategy as much as a compliance task. Align your regulatory approach (classification, local representation, dossier completeness) with your sales, distribution and procurement plans to protect market access and speed up revenue realization. For a more detailed regulatory strategy and timelines, see our full article on Indonesia Medical Device Product Registration Explained

What types of medical devices need registration?

All medical devices, from low-risk Class A products to high-risk Class D devices, must be registered with the Indonesian Ministry of Health.

How long does the registration process take?

The registration process typically takes between 2 to 6 months, depending on your product’s class (A–D), dossier completeness, and responsiveness to MoH clarifications. We help you expedite approval through accurate dossier preparation, pre-assessment, and constant coordination with the MoH Regalkes team.

What are the classifications and types of medical devices in Indonesia?

Indonesia classifies medical devices (including In Vitro Diagnostics and related products) by risk into four ascending classes: Class A (low risk), Class B (low–moderate risk), Class C (moderate–high risk), and Class D (high risk). This risk-based framework determines the regulatory pathway, required technical documentation, and depth of pre-market review — higher-risk devices face more stringent assessment and evidence requirements.

Typical examples by class:

Class A: very low-risk items, often non-invasive (e.g., adhesive bandages, examination gloves).
Class B: low-to-moderate risk devices (e.g., some simple diagnostic instruments, syringes).
Class C: devices that support or sustain important bodily functions or require tighter control (e.g., catheters, infusion pumps).
Class D: highest-risk devices with major potential patient impact (e.g., pacemakers, implantable prostheses).

There are also product-type distinctions with separate rules or annexes — for example In Vitro Diagnostic (IVD) devices and Software as a Medical Device (SaMD) may have specific classification considerations and evidence expectations. The Ministry of Health / Director General’s regulations set out detailed classification tables, categories, and administrative procedures used by the regulator during evaluation.

Why this matters: the device class directly affects what you must submit (technical file, clinical evidence, quality-system documentation), whether on-site audits or expert reviews are needed, and typical review timelines. Foreign manufacturers normally appoint a local Authorized Representative (or local marketing authorization holder) to file the application and liaise with the regulator.

For a complete device-by-device mapping, registration pathway flowcharts, and a practical checklist you can use when preparing an application, see our full guide: Types of Medical Devices and Their Classification in Indonesia.

What is Regalkes in Indonesia medical device registration?

Regalkes is the official online platform managed by the Indonesian Ministry of Health for medical device registration and approval. All imported or locally manufactured medical devices must be registered through this system before distribution.

Learn more about the Indonesia’s Medical Device Registration Guidelines on our article.

What documents are required for medical device approval in Indonesia?

You’ll need an ISO 13485 certificate, Certificate of Free Sale (CFS), Letter of Authorization (LoA), Device Master File (DMF), IFU (Bahasa), and Clinical Evaluation Report (for higher-risk devices). PRI reviews every document to ensure compliance with MoH and ASEAN Medical Device Directive (AMDD) standards.

Can a foreign manufacturer register medical devices in Indonesia without a local entity?

Yes. We offer a License Holder Service that acts as your local representative in Indonesia. This allows foreign manufacturers to register and distribute their medical devices legally without establishing a local subsidiary by ensuring compliance while maintaining flexibility in choosing distributors.

Do you handle IVD registration in Indonesia?

Absolutely. Our service includes In Vitro Diagnostic (IVD) registration under the MoH Regalkes system. We guide you through dossier preparation, risk classification, and performance verification, ensuring compliance and timely approval.

Trusted by Leading Brands Across Industries

Here are some of the companies that have partnered with us to navigate regulatory compliance and successfully bring their products to market.