WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 7.3-7.6-NRA-pathways: NRA: establish emergency use authorization criteria and validity limits, borderline product and combination product designation processes with published decisions and appeal, and a donation authorization mechanism and policy

What does 7.3-7.6-NRA-pathways require?

The NRA should set up policies and processes for emergency authorization or derogation, with transparent evidence requirements and evaluation criteria developed with experts, strong post-market monitoring and a limited, published validity. For borderline products it should publish criteria and a process for advisory opinions considering presentation, intended purpose and claims, medical purpose, mode of action and similar marketed products, consulting experts and other regulators, with published decisions and appeal. For combination products it should publish designation criteria, decide by primary mode of action, create a single pathway combining both sets of requirements with coordinated reviews and post-market reporting. For donations it should have a national donation policy covering pre-donation, donation and post-donation phases and a mechanism to verify and authorize donated imports, while donor countries should control the export of waste or hazardous devices.