Lean On Me? Global Regulators Look to Reliance

article image

The goal of achieving more extensive reliance between device regulatory authorities dominated discussions during the public sessions of the International Medical Device Regulators Forum conference in Washington, DC, this month. Government officials and industry representatives called for more transparency and a shared playbook to advance the practice.

Device authorities and company officials are calling for development of a global playbook to lay out a standardized approach for countries to integrate “reliance” practices more routinely into their regulatory frameworks. That was one primary takeaway of two days of public discussions at the International Medical Device Regulators Forum’s gathering of the global medtech regulatory community in Washington, DC, this month.

The most frequent terms of art associated with IMDRF are “harmonization” or “convergence,” that is, efforts by different countries to adopt guidelines and processes that are as closely aligned to each other’s as possible to reduce discrepancies in what product developers face in each market. But the concept of reliance, in which one regulator directly leverages the individual decisions of another, takes those efforts a step further in supporting a company’s ability to launch products in more countries over a shorter period time.


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: