Medical Device Registration Indonesia
Navigate Regulatory Challenges with Ease. The Indonesian healthcare market is growing rapidly, offering significant opportunities for foreign and local businesses. However, navigating the complex regulatory requirements can be challenging. At Product Registration Indonesia, we simplify the medical device registration process so you can focus on bringing your products to market efficiently and confidently.
Why Register Medical Devices in Indonesia?
Indonesia’s growing healthcare market presents tremendous opportunities for medical device manufacturers. However, the complex regulations enforced by the Ministry of Health (MOH) require detailed attention and understanding to achieve successful product registration. Our experienced team ensures your devices meet all legal requirements, providing you with a strategic advantage in a competitive market.
Our Medical Device Registration Service
Regulatory Consultation
Our experts assess your device’s 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)
• Distributor License (IPAK)
• Good Manufacturing Practice (GMP) Certificate
• 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
We provide ongoing support to maintain compliance, assist with renewals, and address any modifications required to keep your products on the market.
Why Chose Us?
Deep Regulatory Knowledge
Our experts stay up to date with the latest MOH and ASEAN directives, ensuring a smooth and compliant 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 products 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? 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
Frequently Asked Questions (FAQ)
How long does the registration process take?
The registration process usually takes between 6-12 months, depending on the device classification and documentation.
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.
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.
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.
Key business impacts to consider
- Maintain Control Over Your Product — Whoever holds the NIE effectively controls that product’s regulatory status in Indonesia. If a local distributor registers your device, you can become “locked in” to that partner; using a neutral Local Authorized Representative (LAR) or your own local subsidiary preserves flexibility to change distributors, update labels, or add variants without restarting registration.
- Strategic Regulatory Planning — Correctly classifying your device and preparing a complete dossier up front (technical file, risk analysis, clinical evidence where needed) shortens review cycles and reduces rework. Investing in regulatory gap analysis early accelerates time-to-market and lowers the risk of rejection or delay.
- Synchronize Regulatory and Market Entry — Registration is one element of a broader go-to-market plan: company permits (OSS/RBA), distribution licenses (IDAK/CDAKB), logistics, and hospital procurement listings should be coordinated so your NIE is ready by launch date (tender, trade show, or hospital contract). Misalignment between regulatory milestones and commercial plans can derail sales timelines.
- Leverage Local Requirements to Your Advantage — Local rules (e.g., TKDN/local content reporting, halal or distribution quality certifications) can be turned into differentiators for public procurement or buyer confidence. Planning product design, local assembly, or additional certifications with regulation in mind can unlock tenders and strengthen market positioning.
Practical takeaway: treat 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 NIE, risk classes and regulatory strategy.
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.
