IMDRF Issues Proposed Guidances On Device Auditors, Global UDI System
This article was originally published in The Gray Sheet
The International Medical Device Regulators Forum issued proposed guidance documents on monitoring of device auditing organizations, training for auditors and core elements of a global UDI system.
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FDA is strongly encouraging manufacturers to participate in the Medical Device Single Audit Program, set to launch in a pilot phase by June. An agency official points to strong global incentives, particularly for firms pursuing the Brazil and Canada markets.
The International Medical Device Regulators Forum issued four final guidance documents on an upcoming pilot that will allow companies to satisfy inspection requirements for four countries in one inspection, and separate documents on a global unique device identification program and standalone software.
Official negotiations between the U.S. and EU on the Transatlantic Trade and Investment Partnership trade agreement began last week. Medical device industry associations representing both regions want the harmonization of U.S. and EU device industry regulations to be part of the agreement.