Asia
The new article describes in detail the good assembly practice principles to be applied for medical devices and also provides additional clarifications regarding the traceability-related matters to be considered. Table of Contents The Health Science Authority (HSA),...
EU MDR/IVDR
The new article outlines considerations related to the activities carried out by notified bodies concerning medical devices intended to be marketed and used in the EU. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
FDA
The article provides an overview of the regulatory requirements for monkeypox tests intended to address the public health emergency. In particular, the document describes the current situation with the virus and outlines special extraordinary measures FDA is going to...
Asia
The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated thereto. Table of Contents The Health Sciences Authority (HSA),...
FDA
The new article describes in detail the responsibilities of the regulating authority concerning the determination of risk associated with medical device studies; and also provides some examples illustrating the way the approach described in the guidance should be...
EU MDR/IVDR
The new article describes the matters related to the re-assessment of designated conformity assessment bodies. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical device regulations,...
