Australia
The article provides an overview of the regulatory requirements various sterility products are subject to in order to be allowed for marketing and use in Australia.
AIaMD
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
