N071:2012.
11 Nov 2011 An overview of new GHTF guidance on medical device classification principles.
The International Medical Device Regulators Forum (IMDRF) is continuing the work of the Global Harmonization Task Force (GHTF). GHTF was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems.
2 Nov 2012 The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess whether a
Georgette Lalis, GHTF Chair. The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and

Brochure: The IAF Initiative for Accredited Certification to ISO 13485 - Medical Devices. Relationship to guidance from the Global Harmonization Task Force (GHTF). ISO 13485 Medical Devices IAF Br Global Harmonization The IAF ISO 13485 medical devices initiative has been optimized using GHTF guidance. For many
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry" whose goal was the standardization of medical device regulation across the world.

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March 2018