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: