Europe requires the CE-marking for all medical devices based on the newly introduced Medical device regulation (MDR).
The United States, Canada and e.g. Mexico have complete different approaches on how the medical devices are regulated.
The requirements for introducing medical devices into the Asian market are as diverse as the countries themselves.
When establishing harmonised technical and regulatory requirements in the new EURASIAN Union the EAEU used similar principles as used in the EUROPEAN Union with the intention to replace the individual countries' registrations.
Australian requirements for getting medical devices onto the market have always been very close to the European requirements. Are they further following the European principles introduced with the MDR?
Many countries in South America are members of the MERCOSUR or the PAHO. Under the MERCOSUR the requirements to import medical devices into the member states are based on the same principles but applied differently.
You did not find the region or country you are looking for ?
Please see the country specific sites under "Region" or contact us directly under "CONTACT".
Our main focus is to support manufacturers of medical devices to get their products registered around the world.
Why not using our experience to accelerate your market access in over 65 countries.
QUADRAS - Bodo Mestmacher - EST. 2006
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