US Life Sciences Regulatory and Enforcement Update
Take a look back at the key regulatory and enforcement issues impacting the industry in 2021.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Understanding Regulations in China, Japan and India for Device Expansion and Clinical Operations Excellence
Join us as we explore the advantages and intricacies to setting up a clinical study in China, India and Japan
AdvaMed Submits Recommendations to Department of Commerce to Address Semiconductor Chip Shortage and Supply Chain Issues
Today, the Advanced Medical Technology Association (AdvaMed) submitted a response to the Department of Commerce’s request for comments on the risks in the semiconductor supply chain.
AdvaMed Welcomes Cody Uhing as Director of Media Relations, Communications
The Advanced Medical Technology Association (AdvaMed) announced that Cody Uhing recently joined the association as director of media relations and communications.
Key Changes to Clinical Evaluation in China Webinar
Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices
AdvaMed launches Code of Ethics on Interactions with Health Care Professionals in India for Medtech Sector
The Advanced Medical Technology Association (AdvaMed) has launched the AdvaMed Code of Ethics on interactions with health care professionals in India. It provides medical technology and diagnostics makers with compliance principles and guidance…
CVRx CEO Nadim Yared Joins Podcast in Two-part Episode to Discuss the Latest in Cross-Sector Collaboration and Startup Leadership
Recently, Nadim Yared joined host Scott Whitaker on the Medtech POV Podcast in a 2-part episode to discuss his expansive career, transition to a startup company and work with the…
AdvaMed Cybersecurity Summit
The AdvaMed Cybersecurity Summit features experts from across the medical device and healthcare cybersecurity landscape to help you navigate this complex threat environment and the FDA regulatory requirements that continue…
BD Unveils Nebraska-Based Manufacturing Capacity to Support U.S. Vaccination Agility and Preparedness
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has strengthened the U.S. government’s access to safety injection devices through increased manufacturing capacity…
Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid…