Medical Device Blog

Market Entry doesn’t have to be slow or costly. Smart regulatory planning helps startups and manufacturers accelerate access to the EU, UK, US, and beyond transforming compliance from a burden into a strategic advantage. The Global Regulatory Maze - Market entry Expanding into international markets is a defining milestone for every manufacturer—but it can also be one of the most daunting. Divergent frameworks such as EU MDR/IVDR, UKCA, FDA, TGA, and Health Canada regulations

Clinical Decision Support Software in Australia: When Is It a Medical Device? Introduction As digital health technologies evolve, the boundaries between health apps and medical devices have become increasingly complex. To provide clarity, the Therapeutic Goods Administration (TGA) released updated guidance in October 2025 titled “Understanding Clinical Decision Support Software (CDSS)” , outlining how clinical decision support systems are regulated under the Therapeutic Goods

The EU MDR Rule 21 reshapes how substance-based and bioengineered medical devices are classified and approved. Learn how innovators in biomaterials, nanotech, and regenerative medicine can navigate compliance to bring disruptive therapies to market. The Changing Landscape of Medical Device Regulation The introduction of Rule 21 under the EU Medical Device Regulation (MDR 2017/745) has redefined how Europe regulates a new generation of medical devices, particularly those compo

MDCG 2025-7 outlines deadlines for implementing Master UDI-DIs for contact lenses, spectacle frames, and reading spectacles. Ensure MDR compliance with AF Pharma as your EU Authorized Representative.