Medical Device Tag

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Changes to Medical Device Regulations in China

The Chinese medical device market and regulatory landscape has undergone a myriad of changes in the past few years. China’s Medical device requirements have been extensively revised; in 2013, the Chinese Food and Drug Administration (CFDA) released 107 new medical device standards….

White Paper

Early Feasibility Medical Device Clinical Studies

On October 1, 2013, the Food and Drug Administration (FDA) released a final guidance document, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.” This guidance was developed to facilitate the early clinical…

White Paper

New Medical Device Regulations in the European Union

Ever since the new EU medical device and IVD regulations were proposed in September 2012, the medical device industry has been attempting to gain a firm grasp on what they need to do to be compliant and prepared. There has been talk…

White Paper

De-Mystifiying the De Novo Process

The De Novo process was first introduced in 1997 with the implementation of the FDA’s Modernization Act (FDAMA). [1] It was meant as a means to reclassify novel devices of low to moderate risk profiles that were automatically deemed Class III because…