Medical Device Regulatory Requirements - Various Countries

phfrasier

Starting to get Involved
#1
My question is pertaining to the regulatory requirements of foreign countries to import our medical devices. We are a manufacturer of Class IIa and Class III disposable pain management medical devices. We have CE Marks on our products, so my question isn't so much concerning the EU, but other countries in South America, Asia and the Middle East. Does anyone have experience in dealing with these countries? I know many require a Certificate to Foreign Government an additional device information. I would like to prepare a matrix outlining requirements based on the country. I am aware that Australia is a whole different ball game. Is New Zealand harmonized with Austrailia? Any help would be much appreciated.
 
Last edited by a moderator:

Stijloor

Super Moderator
Staff member
Super Moderator
#2
Re: Various Countries Regulatory Requirements

My question is pertaining to the regulatory requirements of foreign countries to import our medical devices. We are a manufacturer of Class IIa and Class III disposable pain management medical devices. We have CE Marks on our products, so my question isn't so much concerning the EU, but other countries in South America, Asia and the Middle East. Does anyone have experience in dealing with these countries? I know many require a Certificate to Foreign Government an additional device information. I would like to prepare a matrix outlining requirements based on the country. I am aware that Australia is a whole different ball game. Is New Zealand harmonized with Austrailia? Any help would be much appreciated.
Hello phfrasier, and welcome to The Cove Forums! :bigwave: :bigwave:

I am not a medical devices expert, but I did an advanced search for you on: "Medical Devices Various Countries."

See if you can find the information you need.

Stijloor.
 

phfrasier

Starting to get Involved
#3
Re: Various Countries Regulatory Requirements

That pointed me to a thread that had a link for what appears to be exactly what I needed. Thank you very much!
 
Last edited by a moderator:

Stijloor

Super Moderator
Staff member
Super Moderator
#4
Re: Various Countries Regulatory Requirements

That pointed me to a thread that had a link for what appears to be exactly what I needed. Thank you very much!
You're very welcome.

Please tell others about this great resource: The Cove Forums.

Stijloor.
 
Top