ARTICLE SUMMARY:
The International Medical Device Regulators Forum met in Germany last week. Here are five noteworthy regulatory agency updates we heard at the meeting, from reports out of China, Japan, Canada, Switzerland, and the World Health Organization. (Photo: IMDRF panel discussion/IMDRF)
Medtech regulators from around the world convened last week in Berlin to share best practices, challenges, and strategies to reduce duplicative global requirements to device developers. It was the biennial meeting of the International Medical Device Regulators Forum.
The meeting is in part intended as an opportunity for the IMDRG Management Committee—comprised of representatives from 11 regulatory bodies (from 10 countries and the EU)—to meet behind closed doors to approve new globally harmonized guidance documents and other group policies. Any public output from those efforts will be published by the group in the coming weeks.
But the gathering also has a public side, giving national agencies and other organizations the opportunity to share with the rest of the world what they are working on domestically. For industry stakeholders, it’s an opportunity to hear about oncoming initiatives that otherwise might remain under the radar. Market Pathways listened closely to these sessions. Here are five updates we found most notable, including upcoming legislative reform in China, a novel approval route for software anticipated in Japan, as well as updates from Canada, Switzerland, and the World Health Organization:
