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GHTF SG1 Definition of the Terms ‘Medical Device’ …

    https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf
    The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to facilitate trade whilst preserving the right of participating members to address the …

GHTF SG1 Principles of Medical Devices …

    https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf
    Medical device: See GHTF guidance document: Definition of the Term ‘Medical Device’. Reusable medical device: Means a device intended for repeated use either on the …

GHTF SG1 Principles of Medical Devices …

    https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf
    Definition of the Term ‘Medical Device’ (GHTF/SG1/N29:2005). Reusable surgical instrument: Instrument intended for surgical use by cutting, drilling, sawing, scratching, …

Glossary and Definitions of Terms Used in GHTF …

    https://www.imdrf.org/sites/default/files/docs/ghtf/final/steering-committee/procedural-docs/ghtf-sc-n4-2012-definitions-of-terms-121109.pdf
    Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or to support in …

GHTF SG1 - Definition of the Term Medical Device

    https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n29r16-2005-definition-medical-device-050520.pdf
    The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical …

GHTF SG1 Definition of the Terms ‘Medical Device’ …

    https://www.gs1.org/docs/healthcare/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf
    The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical …

IMDRF/MDSAP WG and GTHF Documents | FDA

    https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/imdrfmdsap-wg-and-gthf-documents
    “IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global …

Nonconformity Grading System for Regulatory …

    https://www.fda.gov/media/94459/download
    This document was produced by the Global Harmonization Task Force (GHTF), a voluntary group of representatives from medical device regulatory authorities and the …

What are Medical Devices? - News-Medical.net

    https://www.news-medical.net/health/What-are-Medical-Devices.aspx
    The Global Harmonization Task Force (GHTF) has proposed several harmonized definitions for medical devices. Medical devices, according to the WHO, …

GHTF SG1 Definition of the Terms ‘Medical Device’ …

    http://www.ahwp.info/sites/default/files/2017-07/FINAL_GHTF%20SG1%20Definition%20of%20the%20Terms.pdf
    ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent, software, material or other similar or related article, intended by the …



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