ARTICLE SUMMARY:
In this week’s roundup: We mark the date of application for the Medical Device Regulation, look to reforms next week in China, and monitor FDA’s pick-up in activity with reports on COVID-19 testing and device materials and new draft guidance on postmarket data mandates. Also: there’s a new CMS administrator, AdvaMed engages in semiconductors, and more
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What we’re watching for:
MDR policy train continues. At long last, MDR day is here. Even with the Medical Device Regulation now in full force, there is still a lot more to do to get it fully implemented. With the EU Medical Device Coordination Group meeting over the next few days, here are a few specific items to look out for in the coming weeks: a “frequently asked questions” on the new European Medical Device Nomenclature; a guidance on terminology on patient “implant cards” that are required under 
MDR; and two guidelines related to implementation of Europe’s unique device identification system.
China reforms. Much device regulatory attention today and this week is centered on Europe and the MDR, but there is another important regulatory reform about to kick in. China’s comprehensive update to its “Regulations on the Supervision and Administration of Medical Devices” takes hold in less than a week, on June 1. There has been a much shorter build-up to these reforms, compared to the four years of transition for the MDR. But, the China updates are nonetheless important modernizing provisions for the country’s oversight of devices, solidifying the path to contract manufacturing, clarifying clinical trial policies, and tightening penalties for noncompliance. (See “Five Things to Watch in China’s Upcoming Device Reg Reforms, ”Market Pathways, April 15, 2021.) The National Medical Products Administration last week issued a series of draft guidelines linked to the new regulation, on topics including clinical evaluation for devices and IVDs, trial exemptions, and device registration forms, seeking comments from industry by May 31, the day before the new rules take effect. (For links to the drafts, check out Pathways’ Document Depot.) More implementing documents are likely to come, and, in Market Pathways, look soon for more in-depth coverage of anticipated impacted of the reforms on industry’s operation in China.
