Hello Raushan,
The GMDN Agency has been adjusting some codes to better align with the FDA GUDID system and other UDI systems. Some terms may have been obsolete due to duplication, redundancy, or similar terms being used. If you do believe a current code is not appropriate for your device, or an obsolete was better, you can request a new GMDN code. To do this, the company must be a subscriber and go through the process described on the site. Alternatively, use the links in the article Dan provided to try and find an alternative one, because while getting a new GMDN Code might be appropriate, there may be other reasons a code was obsolete.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jun-2023 10:33
From: Dan O'Leary
Subject: GMDN Code
<o:p> </o:p>
The GMDN Agency recently posted an article that explains how to deal with this. See https://www.gmdnagency.org/news/article/2001263<o:p></o:p>
<o:p> </o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 22-Jun-2023 08:18
From: Raushan Blake
Subject: GMDN Code
Hello,
I am currently working in the Medical Device segment, and two of the products which I am handling, have got their GMDn codes gone Obsolete.
I wanted to know what is the process to obtain a new code. Or can a new code be acquired?
The website doesn't discuss much on it related to the obsoletion of codes.
Regards,
Raushan Blake
PharmD
MSc Pharmaceutical Regulatory Affairs
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Raushan Blake
Regulatory Affairs Specialist
Castletroy
Ireland
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