Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device Regulatory Reliance Programme between the country and China. Medical Device ...

Meanwhile, Malaysia and China have started aligning and streamlining their medical device registrations through a first global regulatory reliance programme.

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and ...

The FDA’s decision to clear the Apple Watch is a big deal because it shows they are open to new kinds of medical devices. It ...

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

Several key senators have reintroduced a bill that seeks to establish a Medicare coverage pathway for breakthrough early-detection cancer tests.

The 510 (k) pathway is one of several regulatory pathways by which medical devices, including those with breakthrough designations, can receive marketing authorization from the FDA.

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 ...

CMS' TCET program expedites coverage for FDA breakthrough medical devices. A bill is also making its way through Congress that would replace the rule.

Understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. Whether you’re ...

We strive to de-risk the regulatory pathway for our customers’ medical devices, to make sure that we are always conscious of the effort needed to their safety and performance, and to smooth out US ...