WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.3.3-NRA-import: NRA: decide which device categories need extra import controls, train customs, designate ports of entry, and hold powers to stop non-compliant imports

What does 6.2.3.3-NRA-import require?

The NRA determines which risk classes or categories require additional import controls (pre-shipment document approval, port or premises verification, sampling of suspected falsified products, IVD lot verification), arranges cooperation with customs and other agencies including training on device rules such as labelling, may designate official ports of entry, and must have enforcement powers to prevent non-compliant devices entering; extra import controls can be relaxed once registration and listing mature.

Maintained by Gerard Blokdyk

Other controls in Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

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 endpointAll WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices controls