Europe requires the CE-marking following a conformity assessment based on the newly introduced Medical device regulation (MDR) that includes for the majority of devices the involvement of a Notified Bodies .
The United States, Canada and e.g. Mexico have complete different approaches on how the medical devices are regulated.
Many countries in South America are members of the MERCOSUR or the PAHO leading to similar principles importing medical devices but applied different in every country.
The requirements for introducing medical devices into the Asian market are as diverse as the countries themselves. Whereas China and Japan developed there own systems other countries rely on established procedures.
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?
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Our main focus is to support manufacturers of medical devices to get their products registered around the world.
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QUADRAS - Bodo Mestmacher - EST. 2006
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