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Dregs Couverture der - WHO

MEDICAL DEVICEREGULATIONSG lobal overview andguiding principlesWORLD HEALTH ORGANIZATIONGENEVADEPARTMENT OF BLOOD SAFETY AND CLINICAL TECHNOLOGYWORLD HEALTH ORGANIZATION1211 GENEVA 27 SWITZERLANDFax41 22 791 4836E-mail 4 154618 2 HEALTHCARE TECHNOLOGY LIFE CYCLEDe-commissioningMaintenanceTraining OperationTechnology assessmentEvaluationPlanningProcurementI nstallationCommissioningAssessment of needsResearchDevelopmentTestingManufactu reMarketingTransferDistributionACQUISITI ONUTILISATIONPROVISIONMEDICAL DEVICEREGULATIONSG lobal overview andguiding principlesWORLD HEALTH ORGANIZATIONGENEVAA cknowledgementsThis guide was prepared under the principal authorship of Dr Michael Cheng. It is basedon a similar publication issued by the Pan American Health Organization (PAHO) in1999 that reviewed the Canadian Medical Devices Regulatory comments and suggestions made by members of the Global Harmonization TaskForce and those of many other reviewers are gratefully Department of Blood Safety and Clinical Technology thanks the Governments ofItaly and Luxembourg for their continued support to its work on medical devices.

Priorities on the international agenda 36 Annex 1. Resources for medical device information 37 Annex 2. Final documents of the GHTF as they relate to the Common ... Note: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection devices, control materials, and related.

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