WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices

The Global Model Regulatory Framework for Medical Devices 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. The document is written for the legislative, executive and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country’s regulatory authority for implementing and enforcing the regulations.