GMDN (Global Medical Device Nomenclature) Australia, Japan, Turkey, Brazil

#1
According to the GMDN Agency, GMDNs are already mandatory in the following countries:

Australia, Japan, Turkey, Brazil.

[FONT=&quot]Can anyone verify this, together with reliable supporting evidence, independent of the GMDN Agency or their website? [/FONT][FONT=&quot]
[/FONT]
 
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Ronen E

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#2
Yes, I can confirm for Australia, though the requirement relates to a TGA "GMDN" system which they state is somewhat different to the agency's.

Supporting evidence can be found through this link:
http ://www .tga. gov .au/devices/argmd.htm - DEAD 404 LINK UNLINKED

Cheers,
Ronen.
 
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S

SedefA

#3
And I will confirm for Turkey. In Turkey if you want to sell (and for reimbursement) you have to register your product to National Data Bank,called UBB. You could find detailed info from following web address:

Actually for devices (93/42/EEC), (90/385/EEC) and (98/79/EC) registration approval from MoH is mandatory.
Regarding registration you have to use GMDN codes. And if GMDN code is on negative list, you d not have get reimbursement for product.
 

Adele

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#4
According to the GMDN Agency, GMDNs are already mandatory in the following countries:

Australia, Japan, Turkey, Brazil.

[FONT=&quot]Can anyone verify this, together with reliable supporting evidence, independent of the GMDN Agency or their website? [/FONT][FONT=&quot]
[/FONT]
Ronen E has already confirmed for Australia. In Australia, medical devces must be listed and have an ARTG number. These listings are done by GMDN code and class. You may also find that the GMDN code on the TGA website is different to that on the GMDN Agency. We also found that the GMDN Agency will obsolete or change a GMDN code so it isn't the best fit anymore but the TGA will still have it. You are charged per listing (application and annual fee) so it can get pricey for relatively little benefit.

As for Japan, they use a slighly different version of the GMDN called the Japanese Medical Device Nomenclature (JMDN) and it is again used in a slightly different way. The classifications of the device are assigned to the JMDN code selected. I don't believe there is an official English translation of the JMDN so it makes accessing it difficult in order to supply supporting evidence. It is mentioned in the Emergo Group document - http: //www .emergogroup .com/files/medical-device-regulatory-process-japan.pdf. - MAY BE Japan Regulatory Approval Process for Medical Devices

When we first got involved in Japan and JMDNs, we selected the exact GMDN code and we were shocked to see that the majority of our Class II products ended up in Class III. So instead of using a broad GMDN that encompassed a number of products, we broke it down to specifics.

Not sure Turkey or Brazil.
 
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