WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices. WHO Technical Report Series, No. 1003, 2017, Annex 4
(2017; 76 pages)


In the context of Resolution 67.20, the growing interest in medical devices in the global health community and the lack of regulatory systems for medical devices in many countries, WHO decided to develop this document. It is intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries. This WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices (IVDs) (hereafter referred to as the Model) will provide a basis for such work.

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