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How “Regulatory Sandboxes” Offer Hope For New Technologies That Don’t Fit The Regulatory Mold

 
• By Amanda Maxwell

Globally, a new regulatory approach is being adopted increasingly frequently to understand and manage the growing number of cutting-edge medical technologies that sit uncomfortably within current regional or local regulatory structures.

Child playing with his truck toy on a sunny summer day sandy background.
A Safe Space For Regulators, Industry And Other Stakeholders To Play With Innovative Device Concepts • Source: Shutterstock

The pace of medtech innovation seems inexorable. So much advanced technology is becoming available, including through digital health and artificial intelligence, which is revolutionizing the way medical devices and IVDs are being designed and used. Medtech products that do not sit well within the confines of current regulatory environments are becoming increasingly commonplace.

With the promise of exciting new devices and services for patients, and lower costs for health services, there are a growing number of mechanisms being developed across the world. Their...

Key Takeaways
  • Regulatory sandboxes can help accelerate the development and commercialization of tricky-to-regulate innovative medical devices.
  • There is a need for harmonized eligibility criteria and guidance on the use...

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