Global Med Device Authorities Vary In Adoption Of Standards
This article was originally published in The Gray Sheet
Executive Summary
The number of international technical device standards that are fully recognized or considered mandatory by eight major medical device markets ranged from a low of 44 in Australia to a high of 261 in the U.S., and there appears to be limited overlap in the specific standards adopted by each of the countries, according to data presented at a recent International Medical Device Regulators Forum meeting.