医疗器械政策的发展，第2版。

Second edition WHO medical device technical series Development of medicaldevices policies Second edition WHO medical device technical series Priority/Essential lists Regulation Assessment Management Compendiums Technical specifications Development of medical device policies, second edition (WHO medical device technical series) ISBN 978-92-4-011440-1 (electronic version)ISBN 978-92-4-011441-8 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGOlicence (CC BY-NC-SA 3.0 IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided thework is appropriately cited, as indicated below. In any use of this work, there could be no suggestion that WHO endorsesany specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then youmust license your work under the same or equivalent Creative Commons licence. If you create a translation of this work,you could add the following disclaimer along with the suggested citation: “This translation was not created by the WorldHealth Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original Englishedition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules ofthe World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.Development of medical device policies, second edition. Geneva: World Health Organization; 2025(WHO medical device technical series). Licence:CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, seehttps://www.who.int/publications/book-orders. To submitrequests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such as tables, figuresor images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission fromthe copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work restssolely with the user. General disclaimers.The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area orof its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps representapproximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, thepublished material is being distributed without warranty of any kind, either expressed or implied. The responsibility for theinterpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use Design and layout by Genève Design. Contents Preface..............................................xiAcknowledgements.....................................xiiiAbbreviations..........................................xvGlossary............................................xviExecutive summary....................................xviiiIntroduction..........................................1Methods............................................3 1.Global health and medical devices____________________________6 1.1Scope of medical devices61.2United Nations 2030 Sustainable Development goals andforthcoming goals71.3Universal health coverage81.4Primary health care81.5Input, process and outcomes for medical devices91.6Impact of AI on medical devices and related human resources91.7Political support101.8Foundations for action: World Health Assembly resolutions101.9WHO tools and guidance documents111.9.1Equitable access to medical devices121.9.2Global atlas of medical devices141.9.3Global status of medical devices policy14 2.Medical devices in the health systems of Member States_________15 2.1Alignment of medical device policies with the national health plan152.1.1Policy-making162.1.2Planning172.1.3Policy implementation and management172.1.4Policy revision172.2Elements of medical devices policies182.3Alignment of medical device policy with nat