Canada
The article provides a general overview of the approach to be followed when applying for a medical device license necessary to place a new product on the market.
FDA
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
FDA
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
Canada
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
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