Australia/Canada and USA v's EU Medical Devices Regulations Comparison

L

lenwelshlass

#1
Hi Guys

I have been set a challenge to certify our device (Class IIb wound dressing) against all of the above medical device regulations.

I wondered if anyone had a document which compares each regulation and then highlights what the differences are?

Really appreciate your help!

Thanks all.
Helen :confused:
 
Elsmar Forum Sponsor
#2
Re: Australia/Canada and USA v's EU Medical Devices

Does anyone have any information regarding licensing of medical device product, specifically glucose meter in Bermuda? Any help would be greatly appreciated! :bigwave:
 
#3
Hi,

The TGA (Australian High authority) provides a guidance. I apologize i cannot give you the link because i have a post count lower than 10 (this is the first time that i publish a reply). Nevertheless, put "Australian regulatory guidelines for medical devices (ARGMD)" in google and you'll find quickly this document (refer the section 8 p14 0 7 of this guidance)

This document describes the difference between the Australian and European Regulatory requirements.

I don't know if some similar guidances are provided by the other National High Authority.

I hope that you could find some interesting information,

Cheers,
:bigwave:
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi Guys

I have been set a challenge to certify our device (Class IIb wound dressing) against all of the above medical device regulations.

I wondered if anyone had a document which compares each regulation and then highlights what the differences are?

Really appreciate your help!

Thanks all.
Helen :confused:
I saw that you already visited this thread before posting here:

http://elsmar.com/Forums/showthread.php?t=8973

Were none of the contents there useful?

And, did you try Elsmar's "post attachment list" (little green button next to the lighthouse at the top of the page, left hand side)?
 
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