Medical Device Registration details for the following Countries

I

ISO SORRY - HAPPY

Guest
#1
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 :)
 

Marc

Retired Old Goat
Staff member
Administrator
#3
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.
 

phloQS

Inactive Registered Visitor
#4
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
 

Ajit Basrur

Administrator
Staff member
Administrator
#6
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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