EDA
The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
FDA
The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
FDA
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
BfArM
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.
FDA
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
