M MEa Registered Jun 17, 2019 #1 Jun 17, 2019 #1 Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits?
John Broomfield Staff member Super Moderator Jun 17, 2019 #2 Jun 17, 2019 #2 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that should answer your questions: https://www.who.int/medical_devices/global_forum/Workshop_10_GMDN.pdf In short, an out of date nomenclature could: A. Lengthen time to market for producers B. Make stock control less efficient for users Here the ARTG lists many other reasons for keeping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. Attachments Global Medical Device Nomenclature (GMDN) Workshop_10_GMDN.pdf 1,015.3 KB Views: 300
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that should answer your questions: https://www.who.int/medical_devices/global_forum/Workshop_10_GMDN.pdf In short, an out of date nomenclature could: A. Lengthen time to market for producers B. Make stock control less efficient for users Here the ARTG lists many other reasons for keeping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 Problem Solver Staff member Moderator Jun 17, 2019 #3 Jun 17, 2019 #3 MEa said: Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits? Click to expand... John Broomfield said: As to it being “compulsory”, you would have to consult your lawyer. Click to expand... ...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. Click to expand...
MEa said: Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits? Click to expand... John Broomfield said: As to it being “compulsory”, you would have to consult your lawyer. Click to expand... ...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. Click to expand...
John Broomfield Staff member Super Moderator Jun 17, 2019 #4 Jun 17, 2019 #4 I was concerned about stakeholders who may have relied on the out of date information and may be injured as a result.
I was concerned about stakeholders who may have relied on the out of date information and may be injured as a result.
M MEa Registered Jun 19, 2019 #5 Jun 19, 2019 #5 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.
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.