Disclaimer

Our company is a private service provider offering administrative assistance and business consultancy. We are not an official institution appointed or authorized by the government of the Republic of Indonesia or its relevant institutions to issue or legalize company establishment deeds or business licenses.

All services we provide are supportive and facilitative in nature, including assistance in document preparation, form completion, representation and consultations regarding the procedures for company formation and business licensing in accordance with the applicable laws and regulations of the Republic of Indonesia.

The legality and official issuance of legal documents such as notarial deeds, Ministry of Law and Human Rights (MoLHR) approvals, Business Identification Numbers (NIB), and other licenses are entirely under the authority and responsibility of the relevant government agencies, such as:

The Ministry of Health (MoH),
BPOM,
Licensed public notaries,
And/or other competent government institutions as stipulated by prevailing laws and regulations of the Republic of Indonesia.

By using our services, the client acknowledges and agrees that our services do not substitute official services provided by government institutions or authorized officials, and that legal responsibility for the issuance of formal documents remains with the appropriate government authorities of the Republic of Indonesia.

Frequently Asked Questions (FAQ)

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.