ARTICLE SUMMARY:
Thousands of pages proposing, enacting, and explaining medtech regulations and policies came into being in 2022, contained in the 629 documents captured last year in Pathways’ Document Depot. Here are our picks for the top 10 documents of the year, countdown style, along with an infographic summarizing a year in global medtech documents.
This column highlights findings from Pathways’ Document Depot,a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, nongovernmental groups, and global organizations.
The issues and technology areas addressed within the hundreds of medtech regulations, guidances, consultations, technology assessments, and reports published last year vary widely, reflecting the fundamental diversity of the sector. The relative significance to you of any particular document will very much depend on the specifics of your business and technology focus. If you are looking to help your company market dialysis equipment in China, for instance, an NMPA draft guideline on hemodialyzer review requirements could have been one of the most important items to come over the transom in 2022. On the other hand, if you make hearing aids, FDA’s regulation establishing over-the-counter hearing aids would be something you’d want to dig into closely. But if your focus is elsewhere these documents do not need to be on your radar.
On the other hand, some policy documents have a wider reach and, thus, generate more discussion and debate. Those are the varieties we consider here, in Market Pathways’ first annual top 10 list of medtech policy documents. This is (obviously) a highly subjective exercise. It’s an attempt to reflect some documents with a significant near-term impact on a large proportion of industry, as well as others that could have longer-term implications or that simply express something crucial about current trends in regulation and reimbursement. To broaden our net, we’ve include a related honorable mention for each entry.
And without further ado, Market Pathways’ 2022 Global Policy Docs infographic followed by the Docs of the Year top 10 countdown:
