Medical Device Interim Report

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: …

Post-Approval Studies Program | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/post-approval-studies-program

IDE Reports | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-reports

Final Report: The investigator must submit a final report to the sponsor and to the reviewing IRB within 3 months after termination or completion of the investigation. Other Reports: …

Procedures for Handling Post-Approval Studies Imposed …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-handling-post-approval-studies-imposed-pma-order

Center for Devices and Radiological Health A PAS is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather …

ICH GCP - Initial (first)monitoring visit

https://ichgcp.net/imv

The main purpose of the interim monitoring visits is to review and discuss the study conduct, to confirm that subjects’ safety and welfare is protected at your site, to review storage …

Medical Devices Interim Regulation - SFDA

https://sfda.gov.sa/sites/default/files/2019-10/MD-InterimRegulation-en_0.pdf

National Center for Medical Device Reporting (NCMDR): is an organization managing a database of information on safety and performance related aspects of medical devices …

Incident reporting for medical devices: Guidance document

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

In the context of incident reporting, information on the incident refers to the circumstances required to be reported under section 59 of the Medical Device Regulations. Malfunction or deterioration A failure …

Clinical Study Report (CSR) Template (Drug and …

https://clinicaltrials.gov/ProvidedDocs/70/NCT02959970/SAP_001.pdf

Allergan Confidential SAP 1679-401-006 ACZONE (Dapsone, AGN-225678) Gel, 7.5% 3. List of Abbreviations and Definition of Terms Table 3-1 Abbreviations and Definitions of …

Saudi Arabia: Having Your Medical Devices Authorized?

https://www.johner-institute.com/articles/regulatory-affairs/and-more/saudi-arabia-is-it-worth-having-your-medical-devices-authorized/?ADMCMD_noBeUser=1&moduleToken=5bf1f2ce27a814d949e24cf059cb20734b3f371c&cHash=b516cf0630b695535f6627fd46a28919

Medical devices can only be placed on the market in Saudi Arabia if they have been registered with the SFDA(Saudi Food and Drug Administration)and they comply with the …