Is it compulsory to update the obsolete GMDN codes in ARTG?

[MEa]

Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits?

 

[John Broomfield]

Here is a presentation that should answer your questions:

https://www.who.int/medical_devices/global_forum/Workshop_10_GMDN.pdf

In short, an out of date nomenclature could:

A. Lengthen time to market for producers
B. Make stock control less efficient for users

Here the ARTG lists many other reasons for keeping the database up to date:

Varying entries in the ARTG - medical devices and IVDs

As to it being “compulsory”, you would have to consult your lawyer.

 

[Ronen E]

Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits?

As to it being “compulsory”, you would have to consult your lawyer.

...or the TGA, or your regulatory consultant...

The key sentence in John's link above is:

TGA does not require the sponsor to amend the GMDN code if it becomes obsolete.

 

[John Broomfield]

I was concerned about stakeholders who may have relied on the out of date information and may be injured as a result.

 

[MEa]

Thanks, John!I It seems the GMDN codes change quite often and without being a member of the GMDN it is difficult to keep on top of it.