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

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 ...

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 ...

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, ...

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

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

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 ...

Dublin, March 18, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" has been added to ResearchAndMarkets.com's offering. This ...

This evolving regulatory landscape, with new regulations like the EU AI Act, inevitably poses challenges, especially as digital health solutions can blur the lines between medical devices and non ...