A Guide to Finding GMDN Codes for Free - UKRP
If you work in the medical device industry, you may be familiar with the Global Medical Device Nomenclature (GMDN) system. GMDN codes are alphanumeric identifiers used to classify medical devices and are essential for regulatory compliance and communication across various stakeholders. While accessing GMDN codes often requires a paid subscription, there are a few free resources available that can help you find GMDN codes without breaking the bank. In this article, we will explore some methods to locate GMDN codes for free.
1. GMDN Agency Website:
The official GMDN Agency website (gmdnagency.org) is the most reliable and comprehensive source for GMDN information. Although they primarily offer paid access, they also provide limited free search functionality. Visit their website and use the "Search GMDN term" option to find relevant codes by entering keywords or device descriptions. While the free search may have limitations, it can be a useful starting point.
2. GMDN Lookup Tools:
Several online platforms provide GMDN code lookup tools, allowing you to search for codes based on device descriptions or keywords. These tools often aggregate data from various sources, including GMDN Agency records. Examples of such platforms include Code-Check (code-check.com) and Provenance (provenancesoftware.com). These tools can assist you in finding GMDN codes without any cost.
The main databases are:
Australian TGA Public Database:
1. Go to the ARTG Listing Database: https://www.ebs.tga.gov.au/
2. Search by product name. E.g., “needle”, “cement”
Usually Trade Names and Models are not listed in the registration application. Manufacturers often choose to not include it because if the trade name changes or models are updated, then the registration must be updated as well.
3. Search by manufacturer name
Note that registration for non-Australian manufacturers will show up under the name of the Australian Sponsor, not the legal manufacturer. However, if you open the registration details, you will then find the legal manufacturer’s name & address listed.
4. Click on the down arrow next to the company name. Then select “Public ARTG Summary”
5. Once the PDF opens, you will find the legal manufacturer name and the GMDN information
We have included sample images on how to search and open listings. Note that:
The intended purpose is entered by the Australian Sponsor/Manufacturer and it may not exactly match the GMDN code description, unless the registrant decided to enter the GMDN description as the intended purpose. If the registrant used their own unique intended purpose statement, then it should align closely with the GMDN code description in order to be accepted by the TGA. It also allows you to see what your competitors have included as the device intended use, if of interest.
Even though this is public information, we have removed the manufacturer name, address and registration (“ARTG”) number from the images.
USA FDA Global UDI Database:
The FDA’s Global Unique Device Identification Database (GUDID) is public and lists GMDN terms and definitions for each device.
Go to the GUDID website: https://accessgudid.nlm.nih.gov/
Enter the device generic name, trade name or manufacturer name into the search bar
You will then see a list of all options, which you can further filter on the left sidebar
Click on the device you want to view, then click the red plus button next to “Device Characteristics”, then click the red plus button next to “GMDN”
3. GMDN on Medical Device Regulators' Websites:
Many medical device regulatory authorities across different countries require GMDN codes for device registration. Some regulatory websites provide GMDN code lookup features to assist with compliance. Explore the regulatory websites of countries like the United States (FDA), European Union (EU), Australia (TGA), and Canada (Health Canada) for device databases that include GMDN codes. These resources can often be accessed freely.
4. Collaborate with Industry Networks:
Engaging with industry networks, forums, or online communities related to medical devices can be valuable in your quest for GMDN codes. Connect with professionals who work in the same field and inquire about their experiences or any available resources for GMDN code identification. Such networks can offer insights, suggestions, or even share relevant databases or tools that they have discovered.
5. Seek Assistance from Regulatory Consultants:
If you are facing challenges finding GMDN codes for specific devices, consider consulting regulatory experts or professionals who specialize in medical device compliance. These consultants typically have access to comprehensive databases, including GMDN codes, and can provide guidance tailored to your specific requirements. While their services may not be entirely free, they can save you time and effort in the long run.
AF Pharma, acting as the UKRP (United Kingdom Responsible Person), offers comprehensive support in obtaining GMDN codes for medical device companies. With access to extensive databases, we provide accurate and up-to-date GMDN codes tailored to your specific devices by our UKRP credentials.
Our experienced team guides you through medical device regulatory compliance, ensuring timely and efficient assistance as UKRP. By leveraging our industry expertise and networks, we connect you with relevant stakeholders, further enhancing your chances of finding GMDN codes efficiently. AF Pharma as UKRP streamline the process, ensuring regulatory compliance and effective communication within the medical device industry.