WHO Global Model Regulatory Framework for Medical Devices including IVD Medical Devices<\/a><\/strong><\/p>\n\n\n\n This document 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 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.<\/p>\n\n\n\n Good Regulatory Practices in the Regulation of Medical Products<\/a><\/strong><\/p>\n\n\n\n The final version of the draft \u201cGood regulatory practices”: guidelines for national regulatory authorities for medical products that were used as a reference in the Standards Alliance 1.0.<\/p>\n\n\n\n IMDRF\/GRRP WG\/N47 FINAL:2018<\/a><\/strong><\/p>\n\n\n\n IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.<\/p>\n\n\n\n IMDRF\/Standards WG\/N51 FINAL:2018<\/a><\/strong><\/p>\n\n\n\n Optimizing Standards for Regulatory Use.<\/p>\n\n\n\n Playbook for Implementation of a Medical Device Regulatory Framework<\/strong><\/a><\/p>\n\n\n\n The information provided in this playbook is primarily based on the Global Harmonization Task Force (GHTF) guidance documents and approach. The playbook is intended to guide regulators in the understanding and implementation of an efficient and cost-effective medical devices regulatory system.<\/p>\n\n\n\n Medical Device Single Audit Program (MDSAP)<\/a><\/strong><\/p>\n\n\n\nInternational Medical Device Regulators Forum<\/h2>\n\n\n\n
Asia Harmonization Working Party<\/h2>\n\n\n\n
FDA Medical Device Program Reference Documents<\/h2>\n\n\n\n
Inspections \u2013 Global Harmonization<\/h2>\n\n\n\n
Recommended GRP Implementation Policy for Medical Device Regulatory Agencies<\/h2>\n\n\n\n
Additional Information<\/h2>\n\n\n\n