The Coalition in collaboration with its members, develops positions to influence the development and improvement of technical regulations for medical devices. Supporting countries’ efforts in their journey to reach regulatory convergence and prevention of overly restrictive and or misaligned regulations in the region is a strategic element towards reaching the Coalition’s Mission and Vision.

Following you will find the links to the Position Papers that has been developed to support the Coalition Members and all relevant stakeholders when discussing specific topics and are in need to get visibility to the relevant international standards, references and positions to facilitate the convergence process.

Certificates of Free Sale (CFS) / Certificates to Foreign Government (CFGs)

Identification of Medical Devices

REGULATORY COALITION PRINCIPAL MEMBERS