As well, consider the number of incidents reported, field safety corrective actions (including recalls) initiated each day. The World Health Organization states “ there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups.”Ĭonsider the volume of medical device registrations submitted, renewed and modified globally each day. What is a GMDN code and why do I need one?Ī Global Medical Device Nomenclature (GMDN) code is a way for industry to easily group and identify similar types of products. Therefore, while the public ARTG site is useful to find GMDN codes, and see what your competitors have selected, the best practice is to then compare it against the GMDN Agency’s current database. Part of the reason they do not automatically update their records is that it would impact every active registration using that GMDN code, making the code, which was correct at the time of registration, potentially no longer correct.

However, if a GMDN code was updated or obsoleted, which does happen occasionally, the TGA will not necessarily update its own GMDN database to align with that change. For example, if a new GMDN code has been generated, you can ask the TGA to add this new code into their database for use in a registration. It is fully based on the GMDN Agency’s data, but it is not interlinked for live updates.

This is helpful in situations where you are not sure which GMDN code is correct for your device and would like a consensus based on what other manufacturers have selected.ĬONs: The TGA does not always update their GMDN database. You can see which GMDN code your competitors used, and the intended purpose they entered into the registration application. Even though this is public information, we have removed the manufacturer name, address and registration (“ARTG”) number from the images.It also allows you to see what your competitors have included as the device intended use, if of interest. 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. 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.We have included sample images on how to search and open listings.Once the PDF opens, you will find the legal manufacturer name and the GMDN information.Click on the down arrow next to the company name.However, if you open the registration details, you will then find the legal manufacturer’s name & address listed.

Note that registration for non-Australian manufacturers will show up under the name of the Australian Sponsor, not the legal manufacturer.

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.

Usually Trade Names and Models are not listed in the registration application.

Therefore, you can search the public ARTG to find GMDN codes. The Australian Therapeutic Goods Administration (TGA) requires GMDN codes to register medical devices and IVDs.įurther, the GMDN code and term is included in the device information posted on the TGA’s public database, called the Australian Register of Therapeutic Goods (ARTG).

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