International market access is no small feat for a medical device manufacturer. Compiling the records that show how a device meets one country’s regulatory requirements may not be sufficient to show how a device meets another country’s regulatory requirements. To market a medical device in Europe, the device must be CE-marked to show that it conforms to the European medical device regulatory requirements. However, a medical device manufacturer can re-use the items it uses to meet the European requirements to come close to or meet other international medical device regulatory requirements as well. For example, a manufacturer may not need to build completely different quality systems to meet the European, Canadian, and U.S. regulatory requirements. Likewise, some countries allow the manufacturer’s CE certificates to be an input in a shortened medical device regulatory application.


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