WHO Global Model Regulatory Framework for Medical...

What does 6.2.4.2-FSCA require?

The law should require the manufacturer, itself or via its authorized representative, to tell the NRA in a timely way about any field safety corrective action it is carrying out in the country, and the manufacturer should send field safety notices to affected users. The NRA should be able to track whether corrective and remedial actions by the manufacturer or representative have worked.

Other controls in Post-market obligations: adverse events, field safety corrective actions, withdrawals and post-market surveillance – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

6.2.4.1-AE Report to the NRA serious public health threats, deaths or serious deteriorations in health, and failures or design, labelling or use problems that could cause them, plus any false negative for a Class D IVD; investigate reports passed on by the NRA and report the outcome
6.2.4.3-withdrawal Cooperate with NRA enforcement against unsafe or non-compliant devices, including withdrawal, quarantine and disposal, and review technical documentation and revise labelling when unforeseen harm shows it is inadequate
6.3.3.1-PMS Operate post-market surveillance within the QMS that collects user feedback, reviews the benefit-risk profile, reports the required events, evaluates and takes corrective action, with importers and distributors keeping feedback records

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices controls