International Medical Device Regulators Forum (IMDRF) Progresses
At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force
Device Regulation Changes in Mexico
The Mexican healthcare product regulatory body, Cofepris, has been working to development and release new requirements and agreement for therapeutic goods in Mexico. The changes ar
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
US Food and Drug Administration (FDA) Issue New Regulatory Guidance
The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical devic
