Jun 2, 2020
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
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Jun 2, 2020
FDA
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
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Mar 10, 2020
North America
All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of requirements the applicants must fulfill. Physical...
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Mar 3, 2020
North America
Health Canada, the Canadian authority responsible for medical device regulation, published a notice announcing the implementation of the electronic Common Technical Document (eCTD) format. The appropriate pilot project commenced in August 2019, and now the authority...
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Mar 2, 2020
North America
The US Food and Drug Administration (FDA), the authority responsible for medical device regulations, issued guidance dedicated to recommendations for Dual 510(k) and CLIA Waivers by application pathway. CLIA Waiver: Brief Overview The document describes in detail...
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