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Medical Devices-Asia and ROW Regulato…
ASIA
SINGAPORE (HSA)
HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD)
An SRA i…

Regulatory Intelligence shows path to…
Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture …

Pharma/Biotech – USA, Europe Re…
USA
No Big-Picture Impact for Manufacturers in CMS IRA Updates
In the face of multiple lawsuits…

Medical Devices-USA/Europe Regulatory…
USA (FDA)
Content of Premarket Submissions for Device Software Functions
The purposes of this d…

What Pharma Companies need to know ab…
EU MDR
The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European…

ANVISA New Medical Device Regulation …
On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the Brazili…
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