Harmonization in the Fast Lane? COVID-19 Could Accelerate Medtech Regulatory Convergence

article image

If this global pandemic is not a shot in the arm to medtech regulatory convergence efforts, then what will be? Kim Trautman, the longtime global policy leader at FDA and IMDRF, who spearheaded the Medical Device Single Audit Program, is optimistic. Previous harmonization progress has supported the ongoing COVID-19 response, she tells Market Pathways, and it could serve as a catalyst for future success toward, among other things, a global single review program.

From a high-level political perspective, it is difficult to view the response to COVID-19 as an unbridled success of global cooperation. A pandemic by its very nature is a shared problem faced by a large swath of the globe all at once. But leaders in the US and industrialized countries have reverted at key moments of the crisis to a more nationalistic, protective stance, in some cases leading to delays and inefficiencies.

However, looking a level or two below political realities, into the more technical areas of governance and regulation, experts tell a different story. 


This article is restricted to subscribers only.

Sign in to continue reading.


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