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.
You may also be interested in...
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.