THE SOUTH AFRICAN MEDICAL DEVICE INDUSTRY …

2 1. About SAMED 1.1 Who is SAMED? SAMED - the South African Medical Device Industry Association – is a non-profit voluntary association representing the interests of 160+ companies operating in the Medical Device,

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Prepared for the South African Medical Device …

Industry overview and economic impact assessment for the South African medical technology industry Prepared for the South African Medical Device Industry

of THE SOUTH AFRICAN MEDICAL DEVICES …

Page 5 1.1.2.4 “association Board member” a member of the Board appointed by association members in terms of this Constitution to …

  Members

No R Trade and Industry, Department of/ Handel en ...

This gazette is also available free online at www.gpwonline.co.a STAATSKOERANT, 18 MAART 2016 No. 39832 5 Version 3 dated 2015/11/27 Page 1 of 132 Table of Contents

G N A LGEMENE K ENNISGEWINGS - Samed

This gazette is also available free online at www.gpwonline.co.za STAATSKOERANT, 24 DESEMBER 2015 No. 39561 7 4 C HAPTER 1 INTERPRETATION, CONTEXT …

New South African Customs Acts Information - …

Confidentiality Notice The following presentation may contain CONFIDENTIAL information on DSV’s business. The information you see and hear in this presentation may contain

Unique Device Identification (UDI) - GMTA Global Medical ...

harmonized unique device identification (UDI) system will positively impact many ... databases, such as the FDA’s Global Unique Device Identification Database (GUDID) ... Global Medical Device Nomenclature (GMDN): The GMDN is a system of internationally agreed terms used to identify medical devices. The GMDN database

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A GLOBAL PRESPECTIVE ON UNIQUE DEVICE …

Use of Global Medical Device Nomenclature (GMDN) and a national nomenclature, i.e., China Medical Device Nomenclature (CMDN) CMDN developed and already assigned CMDN to 20% of devices UDI IN CHINA

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The Need for Advancing Global Convergence of Medical ...

Global Medical Device Nomenclature . 2 . White Paper - Global Convergence of Medical Technology Regulation • White Paper adopted by GMTA in April 2017 • Key elements to promote convergence 3 . Global Harmonization Movement • Thanks to GHTF and now IMDRF, international

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Draft New Work Item Proposal (NWIP)-revised For …

These two codes are intended to be used alongside the Global Medical Device Nomenclature (GMDN) to provide a fairly complete coded description of an adverse event.

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Device Categorization: GMDN/SNOMED Terminologies …

Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices of the same type (device types) used …

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Global Medical Technology Alliance

Regulators Forum (IMDRF), the Global Medical Device Nomenclature Agency (GMDN), Asian Harmonization Working Party (AHWP), Latin American Harmonization Working Party (LAHWP), Health Technology Assessment International (HTAi), and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) .

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Global Medical Device Nomenclature: The Concept for ...

Global medical device nomenclature structure The general structure of the GMDN is regulated by requirements stipulated in the standard ISO 15225 Nomenclature – Medical device nomenclature data structure. Figure 1 shows the basic organization of the GMDN data. The data is defined by three levels, associated

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Global Medical Device Nomenclature - Flinders University

medical devices suitable for use by all interested parties globally. On the 1 st of November 2001 the Global Medical Device Nomenclature (GMDN) was published as

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Global Medical Device Nomenclature - Ministry of Public …

Global Medical Device Nomenclature A Short Technical Introduction to the GMDN Version 2002 ... A number that represents a general medical device family to which the term has been assigned. All terms have a primary category; some also have secondary and tertiary categories. The numbers correspond to the category code.

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Assessment of Peripheral Devices (RAPID) - MDEpiNet.org

3 Executive Summary The Registry Assessment of Peripheral Interventional Devices (RAPID) project emerged from the Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of the Medical Device Epidemiology Network (MDEpiNet), a public‐ private partnership

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