IMDRF | Information documents
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Annex_-_Use_of_UDI_Data_Elements_across_different_IMDRF_Jurisdictions.xlsx
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Appendices_A___B_Change_Request_Form_and_Change_Log.xlsx
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Clarification_of_the_Term_Legal_Entity_for_MDSAP_Recognition_Purposes.docx
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Clarification_of_the_Term_Legal_Entity_for_MDSAP_Recognition_Purposes.pdf
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Comment_form_for_Points_to_consider_in_the_use_of_the_IMDRF_Table_of_Content_for_Medical_Device_Submissions_pre-RPS.xlsx
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Data_Exchange_Guidelines_-_Common_Data_Elements_for_Medical_Device_Identification.docx
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Data_Exchange_Guidelines_-_Common_Data_Elements_for_Medical_Device_Identification.pdf
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IMDRF_RPS_Communication.docx
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IMDRF_RPS_Communication.pdf
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IMDRF_Table_of_Contents__ToC__Pilot_Plan.docx
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IMDRF_Table_of_Contents__ToC__Pilot_Plan.pdf
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Maintenance_of_IMDRF_AE_Terminologies.docx
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Maintenance_of_IMDRF_AE_Terminologies.pdf
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Medical_Devices_Post-Market_Surveillance_-IMDRF_National_Competent_Authority_Report__NCAR__Pilot_Plan.docx
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Medical_Devices_Post-Market_Surveillance_-IMDRF_National_Competent_Authority_Report__NCAR__Pilot_Plan.pdf
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Medical_Devices_Post_Market_Surveillance_National_Competent_Authority_Report__NCAR__Pilot_Plan__Implementing_Material.pdf
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Overview_of_Auditing_Organization_Assessment_and_Recognition_Decision_Related_Processes.docx
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Overview_of_Auditing_Organization_Assessment_and_Recognition_Decision_Related_Processes.pdf
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Points_to_consider_in_the_use_of_the_IMDRF_Table_of_Content_for_Medical_Device_Submissions_pre-RPS.docx
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Points_to_consider_in_the_use_of_the_IMDRF_Table_of_Content_for_Medical_Device_Submissions_pre-RPS.pdf
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Recognised_standards_-_Australia.pdf
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Recognised_standards_-_Brazil.pdf
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Recognised_standards_-_Canada.pdf
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Recognised_standards_-_China.pdf
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Recognised_standards_-_Europe.pdf
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Recognised_standards_-_Japan.pdf
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Recognised_standards_-_Russia.pdf
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Recognised_standards_-_USA.pdf
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Round_2_RPS_Beta_Testing_Report.docx
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Round_2_RPS_Beta_Testing_Report.pdf
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RPS_Beta_Testing_Document.pdf
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Standards_WG_Final_Report__List_of_international_standards_recognized_by_IMDRF_management_committee_members.docx
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Standards_WG_Final_Report__List_of_international_standards_recognized_by_IMDRF_management_committee_members.pdf
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Statement_regarding_Use_of_IEC_60601-1_Medical_electrical_equipment_-_Part_1.docx
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Statement_regarding_Use_of_IEC_60601-1_Medical_electrical_equipment_-_Part_1.pdf
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Statement_regarding_Use_of_IEC_623042_2006_Medical_device_software_-_Software_life_cycle_processes.docx
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Statement_regarding_Use_of_IEC_623042_2006_Medical_device_software_-_Software_life_cycle_processes.pdf
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Statement_regarding_Use_of_ISO_10993-12009_Biological_evaluation_of_medical_devices.docx
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Statement_regarding_Use_of_ISO_10993-12009_Biological_evaluation_of_medical_devices.pdf
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Statement_regarding_Use_of_ISO_11137-12006_Sterilization_of_health_care_products_-_Radiation.docx
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Statement_regarding_Use_of_ISO_11137-12006_Sterilization_of_health_care_products_-_Radiation.pdf
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Statement_regarding_Use_of_ISO_14155_2011_Clinical_investigation_of_medical_devices_for_human_subjects.docx
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Statement_regarding_Use_of_ISO_14155_2011_Clinical_investigation_of_medical_devices_for_human_subjects.pdf
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Statement_regarding_Use_of_ISO_149712007_Medical_devices_-_Application_of_risk_management_to_medical_devices.docx
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Statement_regarding_Use_of_ISO_149712007_Medical_devices_-_Application_of_risk_management_to_medical_devices.pdf
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Strategic_Assessment_of_Electronic_Submission_Messaging_Formats.docx
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Strategic_Assessment_of_Electronic_Submission_Messaging_Formats.pdf
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System_requirements_related_to_use_of_UDI_in_healthcare_including_selected_use_cases.docx
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System_requirements_related_to_use_of_UDI_in_healthcare_including_selected_use_cases.pdf
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Use_of_UDI_Data_Elements_across_different_IMDRF_Jurisdictions.doc
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Use_of_UDI_Data_Elements_across_different_IMDRF_Jurisdictions.pdf