Australia
The article outlines the roles and responsibilities of the parties involved in recalls and related activities to be taken to ensure the safety and proper performance of medical devices and other healthcare products allowed for marketing and use in the country.
Australia
The new article describes the approach to be applied with respect to mandatory recalls initiated in order to avoid the customers’ exposure to healthcare products that could potentially be harmful when used for the intended purpose.
FDA
The article provides a general overview of the regulatory framework for innovative medical devices intended to be marketed and used in the US.
FDA
The article provides a brief overview of the eSTAR program and the updates thereto recently published by the US authority.
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.
