Sep 20, 2023
MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
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Sep 20, 2023
FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
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Sep 20, 2023
Mexico
This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...
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Sep 20, 2023
FDA
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
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Sep 20, 2023
MHRA
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
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