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Medical Device Registration details for the following Countries
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Medical Device Registration details for the following Countries
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  Post Number #1  
Old 3rd December 2012, 04:50 AM
ISO SORRY - HAPPY

 
 
Total Posts: 3
Please Help! Medical Device Registration details for the following Countries

Dear All,

Help needed. Below is list of countries and list of up to date necessary documentation is needed for registration of medical devices risk classes; I non sterile, I sterile and IIa.

United Arab Emirates , Saudi Arabia, Israel, Macedonia, Canada, USA, Austria, Great Brittan, Ireland, Netherlands, Tunis, Algeria , Italy ,Ukraine, Kazakhstan, Belorussia, Azerbaijan, Germany, Belgium, Slovakia , Luxemburg , Australia.

Also up to date websites and up to date contact of medical devices agencies in every country would be nice.

Thank you all in advance

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  Post Number #2  
Old 3rd December 2012, 05:24 AM
Ronen E

 
 
Total Posts: 3,736
Re: medical device registration- lots of countries

No worries mate. How much do you pay?...
  Post Number #3  
Old 3rd December 2012, 07:09 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,590
Re: Medical Device Registration details for the following Countries

You might want to first take some time to read through existing discussion threads here. Many of these countries already have discussion threads about them.

I'm sorry to say you are asking too much to expect information about all of those countries in a single discussion thread.
Thanks to Marc for your informative Post and/or Attachment!
  Post Number #4  
Old 3rd December 2012, 07:21 AM
phloQS

 
 
Total Posts: 100
Re: Medical Device Registration details for the following Countries

Very new to RA in medical devices? For the very beginning: The regulation on members of the EU- market are nearl the same. I would recommend a search on CE- mark or CE -Certification requirements. So you can cluster some of your countries. Good Luck

phloQS
  Post Number #5  
Old 7th December 2012, 10:52 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 267
Re: Medical Device Registration details for the following Countries

Here in a site with links to many government minister of health websites.
http://www.emergogroup.com/resources...istries-health

I am not affiliated with Emergo.

Last edited by Sam Lazzara; 8th December 2012 at 02:13 PM.
  Post Number #6  
Old 8th December 2012, 11:37 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,216
Look! Re: Medical Device Registration details for the following Countries

Quote:
In Reply to Parent Post by ISO SORRY - HAPPY View Post

Dear All,

Help needed. Below is list of countries and list of up to date necessary documentation is needed for registration of medical devices risk classes; I non sterile, I sterile and IIa.

United Arab Emirates , Saudi Arabia, Israel, Macedonia, Canada, USA, Austria, Great Brittan, Ireland, Netherlands, Tunis, Algeria , Italy ,Ukraine, Kazakhstan, Belorussia, Azerbaijan, Germany, Belgium, Slovakia , Luxemburg , Australia.

Also up to date websites and up to date contact of medical devices agencies in every country would be nice.

Thank you all in advance
If there are multiple countries to be reviewed, ITA website is a good start - http://www.ita.doc.gov/td/health/regulations.html

This may not have current info but will give a braod understanding of various regulators.
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