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International Regulatory Affairs

You would like to launch your medical device on North American markets?

The US market is one of the largest and most important markets for medical devices, all of which must be approved by the FDA (Food and Drug Administration). The dynamic Canadian market, regulated by Health Canada, is also important for you as a medical device manufacturer due to the fact that a large proportion of medical devices are imported.

However, the approval procedures of both countries differ from the European conformity assessment. Early and careful planning of the submission reduces the necessary effort and enables a synergistic approach. We will work with you to develop an efficient and customized approval strategy, prepare the submission files and manage communication with the authorities, both for FDA submissions (Pre-Submission, 510(k), DeNovo) and for Health Canada submissions (MDL).



Contact your novineon specialist.

Phone: +49 7071 98979 – 147