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GMDN code differences, Manufacturer and Sponsor

#1
Hi,

Can manufactures and sponsors assign different GMDN codes?

The situation is this:

Class I
Sponsor is in Australia
Manufacturer is in Europe

Sponsor has been assigning GMDN codes for a longtime as per the Aus regulatory system, they assign according the end product provided to customer E.g. Surgical light and has assigned the appropriate GMDN code.

The Manufacturer has recently assigned their own GMDN codes but have assigned on a more component like basis E.g. electrical cables, light mounts, which means different GMDN codes and A LOT more registrations.

Does the Sponsor have to change their registrations to match the manufacturer?

Thanks!
 
Elsmar Forum Sponsor
K

katmie

#2
Generally, product should have only one GMDN code. If there are two codes (or more) which applies to your product you should ask GMDN agency to create a new code which fully covers your product. Perhaps, the manufacturer already asked GMDN agency which code is the best for its product and they recommended this which is in use by manufacturer.
 

medwise

Involved In Discussions
#3
According to the Therapeutic Goods Medical Devices Regulations 2002, manufacture is responsible for assigning the GMDN code. Australian sponsor can recommend a GMDN but manufacturer has the final say. Note, manufacturer can maintain multiple GMDN terms specific to regional registrations.
 

QAengineer13

Quite Involved in Discussions
#4
Hi,

Can manufactures and sponsors assign different GMDN codes?

The situation is this:

Class I
Sponsor is in Australia
Manufacturer is in Europe

Sponsor has been assigning GMDN codes for a longtime as per the Aus regulatory system, they assign according the end product provided to customer E.g. Surgical light and has assigned the appropriate GMDN code.

The Manufacturer has recently assigned their own GMDN codes but have assigned on a more component like basis E.g. electrical cables, light mounts, which means different GMDN codes and A LOT more registrations.

Does the Sponsor have to change their registrations to match the manufacturer?

Thanks!
I agree with @medwise previous comment, also remember that the GMDN database is maintained by the GMDN Agency, a not for profit agency based in the United Kingdom. The GMDN agency collaborates with various technical experts from around the world to update the database in alignment with technological advancements.

The GMDN was developed as a result of a mandate given by the European Commission. The original GMDN system was compiled by medical device experts from around the world.
 
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