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Publish Date: 4 Dec 2025
UDI Application Guidance Considerations for Manufacture to facilitate an effective UDI Implementation
Publish Date: 4 Dec 2025
Guidance for Remote Inspections of Medical Device Manufacturers
Publish Date: 4 Dec 2025
Guidance for Control of Sterilized and Implantable Medical Device
Publish Date: 4 Dec 2025
White Paper on Overview of Quality Management System Requirements and Implementation in GHWP member country or region
Publish Date: 4 Dec 2025
Playbook for Design and Implementation of Active Post-Market Surveillance System
Publish Date: 4 Dec 2025
Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non-Safety related Field Corrective Actions
Publish Date: 4 Dec 2025
Guidance on Pre-market submission requirements for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device
Publish Date: 4 Dec 2025
Guidance on Determining of Lead Authority and Communication Process for Combination Products
