How to check the distribution license number of medical devices

Medical devices play a crucial role in modern healthcare, and ensuring that these products are safe, effective, and legally distributed is a top priority for health authorities around the world. One of the key indicators of a medical device’s legitimacy is its distribution license number a unique identifier that confirms regulatory approval and allows for traceability.

Whether you’re a healthcare professional, distributor, or consumer, understanding how to check the distribution license number of a medical device can help prevent the use of counterfeit or unauthorized products. This guide explains everything you need to know about locating, verifying, and interpreting medical device license numbers across various countries.

A distribution license number is a unique identification number issued by a national regulatory authority to authorize the legal sale and distribution of a medical device within a country or region. This number confirms that the device has met all necessary safety, performance, and documentation requirements.

The format and structure of the license number may vary depending on the country. However, the presence of this number on packaging, labeling, or registration databases provides assurance that the device has been reviewed and approved by a competent authority.

Why Checking the License Number Matters

Verifying a medical device’s license number ensures that the product is safe and compliant with local regulations. This helps:

• Prevent the use of substandard or counterfeit devices
• Reduce risks to patient safety
• Maintain compliance for healthcare providers and institutions
• Protect manufacturers and distributors from legal issues

It is especially critical when sourcing devices online or from unfamiliar suppliers.

Where to Find the Distribution License Number

The distribution license number can typically be found in the following places:

• Product packaging
• Instruction for use (IFU) or user manual
• Device label or box
• Official health authority database
• Supplier or distributor invoice or certificate

In some countries, the license number is accompanied by a registration logo or approval mark (e.g., CE mark in Europe or FDA listing number in the U.S.).

Common Terms for License Numbers in Different Countries

The name for a distribution license number can differ from one regulatory authority to another. Here are some commonly used terms:

• FDA Registration Number – United States
• CE Certificate Number – European Union
• AKL Number (Nomor Izin Edar) – Indonesia
• ARTG Number – Australia
• MOH Registration Number – Malaysia
• Medical Device Registration Number – General global term
• License Number or Marketing Authorization Number – Generic references
  

Knowing these variations can help when searching in international databases.

How to Check a Medical Device License Number in Indonesia (AKL)

In Indonesia, the AKL number (Alat Kesehatan Layak) is the official distribution license for medical devices. It is issued by Badan Pengawas Obat dan Makanan (BPOM) or Kementerian Kesehatan RI.

To check an AKL number:

1. Visit the official website of infoalkes.kemkes.go.id
2. Go to the “Data Alat Kesehatan” section
3. Enter the AKL number or device name in the search bar
4. Review details such as manufacturer, product category, and validity status
   

This database is publicly accessible and updated regularly.

How to Check a Device License in the United States (FDA)

In the United States, the Food and Drug Administration (FDA) oversees medical device approvals. License information is found in the FDA Device Registration and Listing Database.

Steps to check:

1. Go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
2. Search using the company name, product code, or registration number
3. Click on the appropriate device entry
4. View registration, listing, and manufacturer details
   

Ensure the product is not marked as “delisted” or “withdrawn.”

How to Verify CE Marked Devices in Europe

In the European Union, medical devices must carry a CE mark, indicating compliance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). The CE certificate number is issued by a Notified Body.

To check:

1. Locate the Notified Body number (e.g., 0123) next to the CE logo
2. Search the Notified Body in the NANDO database at https://nando.europa.eu
3. Contact the Notified Body to verify the certificate
4. Request a copy of the Declaration of Conformity from the manufacturer

Note: There is no central EU database open to the public yet for all devices, but EUDAMED is being developed to serve this purpose.

How to Check an ARTG Number in Australia

Australia uses the ARTG (Australian Register of Therapeutic Goods) to list approved medical devices. Each product receives an ARTG ID number upon registration by the Therapeutic Goods Administration (TGA).

To verify:

1. Visit https://www.tga.gov.au
2. Use the “Search the ARTG” feature
3. Enter the ARTG ID, sponsor name, or product name
4. Review the product’s approval status, sponsor, and manufacturing details

Only devices listed on the ARTG may be legally supplied in Australia.

Verifying Medical Device Licenses in Malaysia

In Malaysia, medical device licenses are managed by the Medical Device Authority (MDA). Each device is issued a unique MDA registration number.

To check:

1. Visit https://mdar.mda.gov.my
2. Use the “Registered Medical Device Search” tool
3. Search by product name, registration number, or manufacturer
4. Confirm product validity and classification

All imported and locally manufactured devices must be registered with the MDA to be marketed legally.

Using Mobile Apps and QR Codes to Verify License Numbers

Many countries are adopting mobile apps and QR code systems to simplify license verification for consumers and professionals.

Examples include:

• Indonesia’s SIPTIK or Infoalkes Mobile App
• China’s NMPA mobile scan verification
• India’s CDSCO barcode system (coming soon)

Simply scan the QR code printed on the product or label to access device information, license status, and safety notices.

Common Red Flags in License Number Verification

When checking license numbers, watch for these red flags:

• License number does not appear in the official database
• Product is listed under a different name or manufacturer
• Registration is expired or “under evaluation”
• No supporting documents like CE certificate or DoC
• Device label contains spelling errors or inconsistent logos
  

If in doubt, avoid using the product until verification is complete.

What to Do If the Device Is Not Registered

If you discover that a medical device is not properly registered:

1. Do not use the device until verified
2. Contact the manufacturer or distributor for clarification
3. Report the issue to the national regulatory authority
4. Retain evidence such as packaging, invoice, or screenshots
   

Regulatory bodies may investigate and issue recalls, warnings, or fines.

Tips for Distributors and Healthcare Providers

Distributors and institutions have a legal responsibility to ensure that the products they supply or use are fully licensed.

Tips for best practices:

• Request license documentation from suppliers
• Perform random checks using official databases
• Train procurement teams on verification procedures
• Keep records of license numbers for audits
• Avoid grey-market or unverified imports
  

Compliance protects both patients and business operations.

Legal Consequences of Using Unregistered Devices

The use or sale of unregistered medical devices can result in serious consequences, including:

• Fines or legal penalties
• Revocation of licenses or permits
• Product seizure or recall
• Loss of patient trust and institutional reputation
• Civil or criminal liability in case of harm
  

Strict adherence to registration laws ensures long-term business sustainability and public health safety.

Benefits of License Verification for Consumers

Consumers may not always be aware that they can check medical device licenses. However, informed buyers can:

• Avoid fake or dangerous products
• Confirm the authenticity of online purchases
• Make informed choices for family health needs
• Report suspicious products to authorities
• Support manufacturers who comply with regulations
  

Education and awareness among consumers contribute to a healthier market.

International Harmonization and Future Developments

Efforts are underway globally to harmonize medical device registration and verification systems. Organizations such as the International Medical Device Regulators Forum (IMDRF) are working to create unified frameworks.

Future developments may include:

• Public access to centralized global databases
• QR code scanning across countries
• Blockchain for tamper-proof device tracking
• AI-powered regulatory intelligence tools
  

These advancements aim to simplify verification and improve safety on a global scale.

Knowing how to check the distribution license number of medical devices is essential for healthcare professionals, distributors, and consumers alike. It ensures that the devices in use are safe, effective, and legally approved. While the process varies by country, the core principles of verification remain consistent: confirm the number through the national authority, examine product documentation, and remain alert to signs of non-compliance.

By adopting a proactive approach to license verification, we can collectively protect public health, support ethical manufacturers, and ensure the continued trust in medical technologies that are so vital to modern healthcare.

Contact Naramedic for further consultation.