The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining, its mission and scope, as well as application forms for joining.
IMDRF is a voluntary group of medical device regulators formed in 2011, and its goal is to accelerate international medical device regulatory harmonization and convergence. Members consist of medical device regulatory authorities from Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea, UK and US. The group replaced the Global Harmonisation Task Force in 2012.
The SOP covers the frequency of IMDRF management committee meetings, the composition of the management committee, expedited procedures for joining the management committee, how countries can join as official observers, and how industry members can join as invited observers.
Regarding industry membership, the guide states that “the representatives from the medical device industry, by accepting the invited observer status on behalf of industry, agree to solicit input for the IMDRF [Management Committee] upon request and to take IMDRF outputs back to industry organizations or companies for review and comment during consultation stages.”…