Did you know the U.S. accounts for over 40% of the global medical device market? 💡It’s a multi-billion-dollar industry driven by innovation, clinical excellence, and demand for quality healthcare solutions. Entering this highly regulated market can be challenging — from FDA 510(k) submissions to establishing local distribution networks, navigating the process alone can be complex. 👉 That’s where CMS SCiDoc comes in. We act as your trusted U.S. Local Representative, helping you:✔ Navigate FDA regulations & 510(k) submissions✔ Streamline market entry✔ Build trust with stakeholders✔ Focus on innovation while we handle the groundwork 🚀 Partner with CMS SCiDoc and unlock your pathway to success in the U.S. medical device market.[…]

The new TGA document, Consultation: Proposed Changes to the Regulation of Assistive Technologies, seeks feedback on the current provisions in the Therapeutic Goods Determination 2018. These provisions classify “household and personal aids, or furniture and utensils for people with disabilities” as excluded goods, meaning they are regulated as consumer goods instead of therapeutic goods.

The European Commission published AI Regulation EU – 2024/1689 to establish a uniform legal framework for the development, market placement, deployment, and use of artificial intelligence systems (AI systems) within the Union. Contact us to help you determine how this regulation works for your SaMD.