The Asian economy has experienced tremendous gross domestic product (GDP) growth over the past decade and is expected to continue at a healthy pace for the next several years. The medical device ...

An initiative that is expected to eventually create a more reliable global marketplace and reduce the presence of illegal medical devices or in vitro diagnostics (IVDs) could inherently, albeit not ...

Explore how digital tools, remote audits, and virtual inspections are transforming medical device registration for faster, safer, and more transparent regulatory compliance.

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...

The Internal Revenue Service has released interim guidance on the medical device excise tax that was included as part of the Affordable Care Act. Notice 2012-77, released Wednesday, provides interim ...