Global: IMDRF Seeks Industry Input on Draft Regulatory Reliance Programs Playbook

The International Medical Device Regulators Forum (IMDRF) has opened a critical consultation period for its Playbook for Medical Device Regulatory Reliance Programs – and your expertise is needed!

This playbook provides a comprehensive roadmap for regulatory authorities and stakeholders to implement reliance programs, fostering efficiency, trust, and alignment across jurisdictions. IMDRF is actively seeking feedback from MedTech professionals and stakeholders on this groundbreaking framework designed to streamline global regulatory processes.

What is Regulatory Reliance?

As defined by the World Health Organization (WHO), it is the process where a regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another trusted regulatory authority or institution.

This approach allows regulators to leverage existing evaluations, reducing duplication of efforts while maintaining their independence and accountability for final decisions.

For MedTech professionals, this means faster market access for safe and effective devices, reduced regulatory burdens, and optimized resource allocation for both regulators and industry.

Key Benefits of Regulatory Reliance

Types of Reliance Programs

The playbook outlines several reliance mechanisms, each tailored to different regulatory needs:

Steps to Develop a Reliance Program

The playbook provides a structured approach for regulators and stakeholders to establish reliance frameworks:

Why This Matters for MedTech Professionals

For manufacturers reliance programs presents substantial operational and strategic advantages. By leveraging existing approvals from trusted jurisdictions, companies can significantly accelerate their time-to-market, enabling faster patient access to innovative technologies. This streamlined approach simultaneously reduces development costs by minimizing redundant testing requirements and documentation burdens, allowing organizations to allocate resources more efficiently toward research and innovation.

For regulatory authorities, reliance frameworks offer an opportunity to enhance oversight capacity in the face of rapidly expanding MedTech innovation. By building on the work of trusted partner agencies, regulators can maintain and strengthen safety standards while optimizing limited review resources. This collaborative model enables more focused attention on higher-risk products and novel technologies while ensuring efficient review of well-understood devices.

Have Your Say on the Future of Medical Device Regulation

This is your opportunity to help shape international reliance practises that could transform how medical devices are reviewed and approved worldwide.

Review the draft playbook thoroughly and prepare your comments using the official template (refer here). Then, you may submit your feedback, under the subject line “Public Consultation on Reliance Playbook”, by email to:

• Kenneth Cavanaugh (kenneth.cavanaugh@fda.hhs.gov)

• Lai Peng Low (low_lai_peng@hsa.gov.sg)

Consultation Period: 31 March 2025 – 30 May 2025

Source: International Medical Device Regulators Forum (IMDRF)