EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
Australia
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
HSA
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
Turkey
The article provides a general overview of the regulatory framework for medical devices with measuring functions.
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