Where to get a medical device distribution license
The medical device industry is tightly regulated to ensure that only safe, effective, and high-quality products reach healthcare providers and patients. One of the most important requirements for businesses operating in this sector is the medical device distribution license. This license serves as official authorization from a national health authority, confirming that a distributor meets all regulatory, operational, and technical criteria needed to handle medical devices. Whether you’re starting a distribution company or expanding into a new region, knowing where and how to get this license is critical for compliance and long-term success.
Acquiring a distribution license is not only a legal obligation but also a mark of credibility and trustworthiness in the eyes of partners, manufacturers, and clients. Regulatory authorities use this licensing system to track accountability, enforce standards, and monitor the flow of medical equipment across the supply chain. In this article, we’ll explore where to apply for a medical device distribution license, what organizations are responsible for issuing it, and what you need to prepare to ensure approval.
Where to Get a Medical Device Distribution License
The first and most important place to get a medical device distribution license is through the national health regulatory authority in the country where your business intends to operate. In Indonesia, for example, distribution licenses for medical devices are issued by the Ministry of Health (Kementerian Kesehatan or KEMENKES). Companies must register through the OSS (Online Single Submission) system and comply with regulations outlined in CDAKB (Cara Distribusi Alat Kesehatan yang Baik), which stands for Good Distribution Practices of Medical Devices. The Ministry assesses your operational procedures, staffing, documentation, and quality management system before granting approval.
In the United States, companies must register with the Food and Drug Administration (FDA). Businesses that distribute Class I, II, or III medical devices must list their establishment and all marketed devices annually. The FDA does not issue a “license” in the traditional sense, but registration and device listing serve as proof that a business is legally authorized to distribute medical devices in the U.S. Additionally, companies must comply with FDA’s Quality System Regulation (QSR), which aligns closely with ISO 13485 standards.
For those operating in the European Union, medical device distribution falls under the purview of the National Competent Authorities (NCAs) of each member state. Distributors must adhere to the Medical Device Regulation (MDR) 2017/745 and may need to notify their respective NCA before engaging in distribution activities. In many EU countries, companies must also appoint a Person Responsible for Regulatory Compliance (PRRC) and maintain a post-market surveillance system. While the process may vary slightly by country, central coordination and oversight are harmonized across the EU.
What You Need to Prepare for License Approval
One of the first requirements for obtaining a medical device distribution license is establishing a registered legal business entity in the country of operation. Regulatory authorities will not grant a license to individuals or unregistered organizations. You must have a company registered with relevant government bodies, including tax identification, business permits, and physical or virtual office addresses. This legal foundation proves that your business is operating transparently and is accountable to national laws.
You also need to appoint a qualified Technical Person in Charge (TPC), known in Indonesia as the Penanggung Jawab Teknis (PJT). This person is responsible for ensuring that distribution operations comply with medical device regulations. The TPC should have a relevant academic background (e.g., pharmacy, biomedical engineering, or health sciences) and must attend training from an accredited institution. Their role includes overseeing incoming and outgoing goods, managing documentation, and serving as the contact point during audits and inspections.
Documentation is a crucial element in the license approval process. Companies must prepare Standard Operating Procedures (SOPs), facility layout diagrams, equipment calibration logs, temperature monitoring records, and training logs. Authorities will review whether the company has systems in place to ensure product integrity, traceability, and recall readiness. In some cases, on-site inspections may be conducted to verify the information submitted. Without accurate and complete documentation, the licensing process may be delayed or denied.
Supporting Agencies and Online Portals for Application
Most countries now have dedicated online portals for medical license applications, making the process more streamlined and transparent. In Indonesia, the OSS RBA (Risk-Based Approach) System is the platform through which businesses apply for a distribution license. This system connects with the Ministry of Health and provides a centralized location for submitting business information, uploading documents, and tracking application status. Once submitted, the application is reviewed by KEMENKES, and any follow-ups are communicated through the portal.
In the United States, businesses can register through the FDA Unified Registration and Listing System (FURLS). This system allows companies to create and manage their Establishment Registration and Device Listing. While there is no physical license document, proof of registration can be downloaded from the system and used to verify compliance. Businesses must also pay an annual fee, which changes each fiscal year, to maintain their active status with the FDA.
For EU-based companies, the EUDAMED (European Database on Medical Devices) is becoming the central platform for registration and regulatory communication. Although not fully operational in all areas, it will eventually serve as the unified database for distributors, manufacturers, and regulatory bodies across the EU. In the meantime, each country’s NCA provides online services for local registration and compliance verification. Some nations also require companies to register in a medical device registry maintained by public health authorities.
Legal and Technical Standards Required for Compliance
To be eligible for a distribution license, companies must comply with specific national and international quality standards. In Indonesia, CDAKB serves as the backbone for compliance, outlining requirements for warehousing, transportation, recordkeeping, training, and recall systems. Companies are required to undergo periodic internal audits and maintain complete traceability of all medical devices in their inventory. Non-compliance can result in license suspension or fines.
Most licensing authorities require companies to align with ISO 13485, the international standard for quality management systems in the medical device industry. Although not always mandatory for distributors, ISO 13485 is often recommended or required for higher-risk products. Implementing ISO standards improves internal processes, boosts audit readiness, and increases global trust in the organization’s capabilities.
Beyond quality systems, compliance with labeling, importation, and reporting rules is essential. Products must be properly labeled with approval numbers, expiry dates, manufacturer information, and usage instructions. If a company handles imported devices, it must secure import permits and declare shipments according to national customs regulations. Distributors are also responsible for post-market surveillance, including adverse event reporting and customer complaint handling.
The Importance of Choosing the Right Distribution Model
When applying for a distribution license, it’s essential to decide whether to operate as an importer, local distributor, or third-party logistics provider (3PL). Each role has different licensing implications. Importers must handle customs clearance and ensure product compliance upon entry into the country. Local distributors are responsible for ensuring storage conditions, traceability, and end-user delivery. 3PL providers, although not involved in sales, must still comply with warehousing and transport standards outlined in national guidelines.
Some businesses may also choose to partner with already licensed entities as part of a strategic entry into new markets. For example, a foreign manufacturer may appoint a local agent who already holds a valid distribution license, saving time and ensuring smoother market access. However, such partnerships require legal agreements and clear role definitions to avoid regulatory confusion or disputes.
Moreover, businesses must consider the long-term scalability of their distribution model. Licensing is not a one-time task but an ongoing obligation. Companies should plan for expansion by ensuring their systems, staff, and facilities can handle increased volume, additional product categories, and future compliance requirements. A well-planned distribution model will not only pass audits but also enable sustainable growth.
Streamlining Your Path to Legal Distribution
Obtaining a medical device distribution license is a critical first step for any company looking to operate in the healthcare sector. Whether you’re based in Indonesia, the United States, Europe, or another region, your business must comply with national regulations, appoint qualified personnel, and maintain rigorous quality systems. Knowing where to get a medical device distribution license—and what documentation and procedures are required—can save time, reduce costs, and prevent legal complications down the road.
By leveraging digital application systems, working with experienced compliance consultants, and building an audit-ready infrastructure, your organization can achieve licensing success and establish itself as a trusted partner in the medical device supply chain. In an industry where safety, accuracy, and traceability are non-negotiable, proper licensing is more than a requirement it’s a commitment to excellence.
Contact Naramedic for further consultation.