Mar 4, 2024
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.
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Mar 4, 2024
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.
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Feb 29, 2024
Malaysia
The article provides a general overview of grouping requirements applicable in Malaysia.
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Feb 26, 2024
Malaysia
The article provides a general overview of grouping requirements applicable in Malaysia.
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Feb 23, 2024
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
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