regulation of (i) common definitions for medical devices and (ii) medical devices and IVD in vitro diagnostics A strategy to determine based on risk risk classification for classification technologies/products seeking market entry. List of EAC Partner States priority IVDs and medical devices, by type and disease and risk classification regulations, guidelines and standard operating procedures for regulation of medical devices and IVDs Recommendations for recognizing regulatory decisions of stringent NRAs or WHO Prequalification Program and process for expedited review, if appropriate.
regulation of (i) medical devices and (ii) in vitro diagnostics based on risk classification common definitions for medical devices and IVD A strategy to determine risk classification for technologies/products seeking market entry. List of EAC Partner States priority IVDs and medical devices, by type and disease and risk classification regulations, guidelines and standard operating procedures for regulation of medical devices and IVDs Recommendations for recognizing regulatory decisions of stringent NRAs or WHO Prequalification Program and process for expedited review, if appropriate.
DRAFT%209%20EAC%20MEDICALDEVICES-DIAGNOSTICS%20REGULATION%20PROJECT%20PROPOSAL-FINAL%20MAY%202015.docx