Resources: Sprint Workshop 1

Navigating MedTech Regulation Pathways in Developed and Emerging Markets

Sprint Workshop 1: Navigating MedTech Regulation Pathways in Developed and Emerging Markets

07 August 2020


Medtech product development and commercialisation for devices and diagnostics is a complex process and has a long gestation period. There are many uncertainties that Medtech product development has to navigate especially during technology development and validation stages of product development as well as being able to meet regulatory standards. Successful navigation of the regulatory maze is important in product development roadmap.

There are subtle and distinct variations in regulatory standards for Medtech products across different geographies especially between developed and developing countries. Another layer of complexity is the continuous change in regulatory landscapes both in mature and evolving markets across the world.

The workshop (virtual webinar), as part of the Longitude Prize Sprint programme, drew upon insights from experts in Medtech regulation and addressed the nuances of regulation in different geographies which will guide Medtech companies in their product development strategies.


Watch the recordings and download our factsheet below

Navigating the MedTech Diagnostics Regulations in India

Regulatory landscape in the African context with a focus on East and South Africa and WHO prequalification pathway

The intricacies of MedTech regulation in the US FDA System

Download the Sprint Workshop Factsheet