Day 4 - Thursday 18th JuneThursday, 18 June 2026 - CEST Time Zone

• Practical examples illustrating the steps required for product registration, clinical evaluation, and market approval under the NMPA system.
• Case studies highlighting challenges and solutions for medtech companies entering the Chinese market, with tips for streamlining compliance and accelerating approval timelines.

• Guide to navigating Japan's approval process
• Practical examples of regulatory pathways for medical devices in Japan, including product registration, clinical trials, and post-market requirements
• Case studies showcasing successful strategies for compliance with PMDA and MHLW regulations, along with insights into overcoming common challenges in the Japanese market

• Highlighting the latest updates in the standard, including new testing methodologies, risk assessment approaches, and expanded requirements.

• Exploring impact of ISO 10993-4 revisions on device development, regulatory compliance, and market readiness.

• Discussing the current landscape of in vitro testing - what is expected in 2026?
• Exploring how different regions are integrating in vitro testing into their approval processes, with examples of successful adoption.
• Addressing barriers to widespread acceptance and exploring strategies to further promote in vitro testing in medical device development.

• Overview of how computational models and artificial intelligence are revolutionizing biocompatibility assessments for medical devices
• Discussing a real-world example showcasing the application of in silico and AI-driven methods in biocompatibility testing.

• Guide to navigating Japan's approval process
• Practical examples of regulatory pathways for medical devices in Japan, including product registration, clinical trials, and post-market requirements
• Case studies showcasing successful strategies for compliance with PMDA and MHLW regulations, along with insights into overcoming common challenges in the Japanese market

For more information, please contact Neha Singh at neha.singh@informa.com

• Exploring obstacles such as regional regulatory differences, varying testing methodologies, and the integration of new technologies.
• Discussing strategies to achieve further harmonization, including collaboration between stakeholders, adoption of alternative testing methods, and leveraging advancements in in silico and in vitro technologies.
• Perspectives on cost and resource saving solutions

• An overview of the GCC regulatory framework for medical devices
• Exploring steps for regulatory approval and identifying common obstacles
• Insights into future regulatory trends and developments in the GCC region

• The United Kingdom is positioning itself as an open, globally aligned market for medical devices through expanding reliance and recognition routes, including those leveraging assessments from the USA, Canada and Australia. These pathways reduce duplication, support fairer pre‑market access and reinforce the UK’s commitment to international regulatory harmonisation. At the same time, the MHRA has introduced practical improvements that enable faster, more efficient implementation of PMCF studies using real‑world clinical infrastructure.
• This session will outline how these reforms enhance UK market attractiveness, what manufacturers should expect next, and how regulatory professionals can prepare for the evolving framework.

• Exploring case-study example of post-launch modification which altered product biocompatibility - lessons learnt and solution insights.

• Understanding the regulatory landscape for PFAS reporting in the US and EU, including key differences and commonalities
• Exploring approaches to align PFAS reporting practices - highlighting lessons learned and actionable strategies for compliance.