EU
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
Malaysia
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
Malaysia
The article provides a general overview of grouping requirements applicable in Malaysia.
United States
The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect necessary safety data to support the relevant claims included in the premarket submission.
United States
The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the ones related to clinical testing, labeling, and modifications.
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