About the Session:

The British High Commission in India, together with Freyr Solutions, BCKIC, and MAHE, is pleased to bring you this session on Navigating UK Regulatory Requirements as part of the UK–India HealthTech Accelerator Programme 2026. The programme supports high-potential Indian healthtech and medtech companies in exploring opportunities in the UK through expert guidance, market insights, and access to the UK health and innovation ecosystem.

This exclusive training session will provide participants with a practical understanding of the UK regulatory landscape for medical devices, Software as a Medical Device (SaMD), and AI-enabled technologies, along with an introduction to digital health requirements that are increasingly shaping market access in the UK.

Led by Freyr's global regulatory experts, the session will combine regulatory insights with practical guidance to help manufacturers navigate compliance requirements, avoid common pitfalls, and accelerate their UK market entry strategy.

Key Takeaways:

• Understand UK medical device classification and regulatory pathways, including MHRA requirements.
• Gain insights into Digital Technology Assessment Criteria (DTAC) and key digital health requirements, including clinical safety, data protection, and cybersecurity.
• Learn about typical regulatory timelines, associated costs, and practical considerations for UK market entry.
• Understand common regulatory mistakes and best practices to support a smoother approval journey.
• Discover Freyr’s Global Regulatory Intelligence tool for regulatory insights and compliance updates to support informed decisions and conduct impact assessments.

Whether you are planning your first UK submission or expanding your global footprint with innovative digital health technologies, this session will provide valuable insights to help you navigate the UK regulatory landscape with confidence. Register now to secure your place!