Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

AI In Medical Devices: A Moving Target For Regulators. Traditional medical devices follow a straightforward regulatory pathway: design, approval and market launch.

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

Asia-Pacific emerges as the fastest-growing region with a projected CAGR of 11.9% during 2025-2032, propelled by availability ...

The EU’s Medical Device Regulation (MDR) 15, which replaced the Medical Devices Directive, has significantly increased the requirements for clinical evidence and post-market surveillance. In the EU a ...

In recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in Europe. In large part, this has meant navigating the requirements of the ...

CytoSorbents plans to ask Canadian health authorities to reconsider rejecting the company's license application for DrugSorb-ATR, an investigational device designed to reduce the severity of bleeding ...

The medical device market in India was worth an estimated $3.2 billion in 2011, trailing only Japan, China and South Korea in Asia. The medical ...