ARTICLE SUMMARY:
Drawing on resources captured in Pathways’ Document Depot, we spotlight several important medtech regulatory and policy documents issued in May: technical insights from China’s regulator on human factors, fundamental insights on regulation and data collection for IVDs, and crucial policymaking for new technology reimbursement.
In May, China’s National Medical Products Administration drafted technical considerations for assessing human factors in medical devices, the International Medical Device Regulators Forum and the US-based Medical Device Innovation Consortium both weighed in on in vitro diagnostics, and the Centers for Medicare and Medicaid Services issued its draft hospital inpatient rule with important medtech proposals.
Those were just a handful of the dozens of important medtech policy documents released last month that are captured in Market Pathways’ newly launched “Pathways’ Document Depot”—an inventory of global medtech regulatory and policy official documents.
