Example of medical device registration number
Medical devices must undergo strict regulatory oversight before they are allowed to be marketed, sold, or used in any country. One of the key elements that proves a device’s legal approval is its medical device registration number. This unique identifier is granted by regulatory bodies to indicate that the product has passed the required safety and performance evaluations.
Understanding what a medical device registration number looks like, how it is formatted, and where it can be found is essential for manufacturers, distributors, and even consumers. This article explores real-world examples, explains how these numbers vary across countries, and offers tips for verifying their authenticity.
Example of Medical Device Registration Number
A medical device registration number is an official code or identification issued by a national regulatory authority confirming that a device has been evaluated and approved for sale or use. It is essentially a license or listing number used to track, verify, and monitor medical products.
These numbers are a key part of a device’s labeling, packaging, and compliance documentation. They allow for quick validation in regulatory databases and ensure traceability in the event of recalls, complaints, or post-market surveillance.
Why Medical Device Registration Numbers Are Important
Medical device registration numbers serve multiple purposes:
- Confirm legal market approval
- Help healthcare providers and consumers verify product legitimacy
- Provide access to product specifications and regulatory documents
- Enable authorities to monitor the safety and performance of devices
Without a valid registration number, a device may be considered unauthorized or even illegal, depending on the region.
General Format of Medical Device Registration Numbers
While the structure of registration numbers varies by country and regulatory agency, they usually include:
- A country or agency code (e.g., FDA, CE, AKL)
- Year or issuance date
- A product classification or category code
- A unique serial or license number
Understanding the format can help you identify where and when the product was registered.
Example from the United States – FDA Registration Number
In the U.S., the Food and Drug Administration (FDA) assigns registration or listing numbers via the FDA Establishment Registration and Device Listing system. However, the actual device license number is not always printed on the label—only the manufacturer’s registration number and the 510(k), PMA, or De Novo number if applicable.
Example:
- 510(k) Number: K123456
- PMA Number: P970004
- Establishment Registration Number: 3012345678
You can search these numbers in the FDA database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Example from Indonesia – AKL Number (Nomor Izin Edar)
In Indonesia, the Ministry of Health (Kementerian Kesehatan RI) assigns a unique AKL number for approved medical devices. This number must appear on the label or packaging of all devices distributed in the country.
Example:
- AKL Number: AKL 123456789012
This number can be verified on https://infoalkes.kemkes.go.id by searching with the AKL number or product name.
Example from the European Union – CE Certificate Number
Medical devices sold in the EU must comply with the Medical Device Regulation (MDR) and bear the CE marking along with a certificate number issued by a Notified Body.
Example:
- CE Marking: CE 0123
- Certificate Number: NB123456789
The number after “CE” identifies the Notified Body, and the certificate number refers to the actual regulatory approval. Manufacturers should also provide a Declaration of Conformity containing the same number.
Example from Australia – ARTG Number
Australia requires all medical devices to be listed in the Australian Register of Therapeutic Goods (ARTG), managed by the Therapeutic Goods Administration (TGA).
Example:
- ARTG ID: 123456
This number can be searched on the TGA website at https://www.tga.gov.au using the ARTG search function. The result will display product information, sponsor, and registration date.
Example from Malaysia – MDA Registration Number
In Malaysia, the Medical Device Authority (MDA) issues unique medical device registration numbers for both local and imported devices.
Example:
- MDA Number: MDA-XYZ-XXXXXXXX
This number consists of the MDA acronym, device classification, and an 8-digit license number. You can search for registered devices at https://mdar.mda.gov.my
Example from Canada – Medical Device License (MDL)
In Canada, the regulatory body Health Canada provides a Medical Device License (MDL) for Class II, III, and IV devices.
Example:
- License Number: 123456
The MDL number can be verified via the Health Canada database by searching with the device name, manufacturer, or number.
Where to Find the Registration Number on a Device
The registration number can usually be found on:
- The outer packaging of the product
- The device label or sticker
- The user manual or instructions for use (IFU)
- The Declaration of Conformity
- Online databases or regulatory certificates
Manufacturers are required to include the number as part of traceability and compliance documentation.
How to Verify the Registration Number
To ensure that a medical device is registered and legally approved:
- Visit the regulatory authority’s official database
- Search using the registration number, product name, or manufacturer name
- Check the expiration date and approval status
- Compare the listed information with the product packaging
- Contact the regulatory authority or manufacturer if in doubt
Always use the official websites of national health authorities for verification.
What If a Device Does Not Have a Registration Number
If a device does not have a registration number:
- It might be unregistered or counterfeit
- It could be a prototype or sample not for sale
- The label might have been altered or removed
- The product may be imported illegally or through gray channels
In such cases, you should avoid using the device and report it to the relevant health authority immediately.
How Often Do Registration Numbers Expire
Most medical device registration numbers are valid for a fixed period—often between 2 to 5 years—after which they must be renewed.
Expiration timelines by country:
- Indonesia (AKL): Valid for 5 years
- EU CE Certificate: Typically valid for 3–5 years
- FDA (U.S.): Annual establishment registration renewal
- Malaysia MDA: 5-year validity
- Australia ARTG: Annual renewal with listing updates
Always check the license’s expiration status to ensure it is active and valid.
Using QR Codes and Digital Platforms for Verification
Some countries and manufacturers use QR codes to make verification easier. By scanning the QR code with a mobile phone, users can view:
- Registration number
- Product specifications
- Approval status
- Manufacturer information
This trend is growing in regions like Southeast Asia, China, and the EU.
Common Mistakes When Reading a Registration Number
When checking registration numbers, avoid the following mistakes:
- Confusing registration with product serial numbers
- Searching in the wrong national database
- Using outdated or expired certificates
- Ignoring Notified Body identifiers in CE markings
- Assuming FDA clearance based on manufacturer claims without checking the actual listing
Verifying each product properly helps prevent health risks and legal issues.
Red Flags in Medical Device Registration
Be cautious of the following red flags:
- Number is missing from label or box
- Mismatched manufacturer names on product and certificate
- Expired or forged certificates
- Vague or generic approval claims (e.g., “FDA Approved” without a number)
- Poor-quality packaging or labeling inconsistencies
Report suspicious products to your national regulatory authority.
Responsibilities of Distributors and Importers
Distributors and importers must ensure:
- Devices have valid registration numbers
- Products are labeled according to local regulations
- Documentation is stored and accessible during inspections
- Compliance with post-market surveillance and recall requirements
Failing to verify registration can result in fines, revoked licenses, or damaged reputation.
How to Request a Registration Number from a Manufacturer
If the number is not readily available, you can:
- Contact the manufacturer directly
- Ask for a copy of the registration certificate
- Request the Declaration of Conformity or device license
- Contact the local authorized representative or distributor
Reputable manufacturers are transparent about their regulatory approvals.
Future of Global Medical Device Registration Systems
As the healthcare industry becomes more globalized, efforts are being made to harmonize registration processes. Developments include:
- Centralized databases like EUDAMED in Europe
- ASEAN harmonization under AMDD (ASEAN Medical Device Directive)
- Electronic Unique Device Identifiers (UDI)
- Blockchain and cloud-based verification systems
These innovations aim to improve transparency, reduce duplication, and protect public health worldwide.
Understanding the example of medical device registration number is more than just decoding a string of digits—it’s about ensuring safety, legality, and trust. Whether you’re checking an FDA 510(k) in the U.S., an AKL number in Indonesia, or a CE mark in the EU, registration numbers serve as the backbone of regulatory compliance in healthcare.
By learning how to read and verify these numbers, healthcare professionals, consumers, and businesses can make informed decisions and help prevent the use of unapproved or counterfeit devices. With global trade and innovation accelerating, registration numbers will continue to be vital indicators of safety and quality in the medical device landscape.
Contact Naramedic for further consultation.