Best foot forward: Which market to enter first?

In today's rapidly evolving landscape of healthcare and technology, navigating the realm of regulatory compliance for medical devices has become an increasingly complex endeavour. With advancements in medical technology, the development and deployment of innovative devices have brought forth immense opportunities for improving patient care and revolutionizing the healthcare industry.

At the same time, however, major markets such as Europe and the UK are experiencing unprecedented regulatory shake-ups in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System.

Achieving regulatory compliance in this intricate landscape is no simple task. It requires a deep understanding of the evolving regulatory landscape, meticulous planning, robust quality management systems, and effective risk assessment strategies.

In this new blog series dedicated to International Market Entry, IMed’s team looks at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and prepare for engaging with regulatory experts that can help them enter foreign markets successfully to expand the global footprint of their products.

This first of four instalment is dedicated to the global regulatory scenario and its opportunities.

Read more on our blog and remember to follow IMed Consultancy Ltd to stay up to date with the other blogs in this series!