Nov 15, 2023
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.
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Nov 15, 2023
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
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Nov 15, 2023
FDA
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
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Nov 9, 2023
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.
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Nov 9, 2023
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.
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Nov 3, 2023
EDA
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
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