Telecom Regulatory Authority of India (TRAI) has released a consultation paper on the regulatory framework for the sale of ...

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 ...

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

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 ...

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 ...

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 ...

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 ...