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    Title: 論醫療器材符合性評估程序之技術性貿易障礙及解決途徑
    A Study of Technical Barriers to Trade and Options for Solution on Conformity Assessment Procedures for Medical Device
    Authors: 劉鈞瑜
    Liu, Chun-Yu
    Contributors: 楊培侃
    Yang, Pei-Kan
    劉鈞瑜
    Liu, Chun-Yu
    Keywords: 醫療器材符合性評估程序
    TBT協定
    相互承認協定
    醫療器材單一稽核計畫
    Conformity Assessment Procedures for Medical Device
    Agreement on Technical Barriers to Trade
    MRA
    MDSAP
    Date: 2019
    Issue Date: 2020-02-05 17:03:26 (UTC+8)
    Abstract: 醫療器材產品與人類身體、生命與健康息息相關,各國基於保護人類生命與健康之目的,往往須透過主管機關監督管理,保障醫療器材的安全與有效性。然醫療器材符合性評估程序措施的施行,可能因限制醫療器材產品的自由貿易,而涉及違反《技術性貿易障礙協定》(Technical Barriers to Trade, 以下簡稱TBT協定)法律規範之疑慮。若欲於保護人民健康與貿易自由化間達到平衡,乃為現行醫療器材產業必須解決的重要議題,故本文旨在檢視各國針對醫療器材符合性評估程序措施所提出的貿易關切,探討此等受貿易關切之措施是否符合TBT協定之法律原則,評估在現有的世界貿易組織(World Trade Organization, WTO)協定架構下是否足以衡平解決貿易障礙與健康維護之爭議,進一步針對目前國際間醫療器材監管框架之發展趨勢,探尋有無其他更適合解決符合性程序造成貿易障礙之途徑,並以此探討之基礎為借鏡檢視我國醫療器材監管架構,給予我國相關醫療器材法規未來可修正之方向。
    經本文分析後發現,因醫療器材攸關人類生命安全,各國採取相當程度的管制措施,雖有其維護公共健康的正當目的,但也因此限制醫療器材貿易的自由流通。在醫療器材符合性評估程序實體方面的措施,本文所探討的貿易關切個案,其適法性的判斷有賴更多具體事證方能進一步認定。惟可確定的乃係這些醫療器材符合性評估程序,確實加諸醫療器材製造商進行重複檢驗之成本,以及進入市場的延宕;在程序方面之措施,則為常見的違反情事,蓋許多國家在制定或修正醫療器材符合性評估措施時,如未通知TBT委員會或給予其他會員國適當的評論期,則有違反透明化義務之疑慮。為解決醫療器材符合性評估程序上述問題,會員國間利用相互承認協定與同等性協定作為解決途徑,近年來國際醫療器材論壇(International Medical Device Regulators Forum, IMDRF)更進一步提出醫療器材單一稽核方案(Medical Device Single Audit Program, MDSAP)計畫,調和國際間醫療器材之符合性評估程序。綜觀我國在醫療器材符合性評估程序,在上市前審查程序中之申請國外製造廠品質系統文件(Quality System Documentation, QSD)與查驗登記上,亦會造成國外醫療器材製造商額外的成本與負擔,故借鏡國際間醫療器材符合性評估貿易關切分析與解決途經,本文建議我國簡化上市前審查流程並且同步認可MDSAP所出具的稽核報告,降低技術性貿易障礙同時加強與國際間的合作。
    Given the fact that the use of medical devices has sifinficant implications on the health and life of human beings, every competent authority, with the aim of protecting human life and health, usually takes regulatory measures to ensure the safety and effectiveness of medical devices. In spiteof the legitimate policy objectives, conformity assessment procedures for medical devices may run afoul of the legal rules of TBT Agreement due to restrictions on free trade in medical devices. For this reason, striking the balance between protecting human health and trade liberalization becomes an important task for the implementation of commormity assessment procedures for medical devices. This article identifies main types of specific trade concerns over the commormity assessment procedures for medical devices under the WTO, and then examines whether these alleged measures comply with relevant rules under the TBT Agreement. In addition, this article further evulates these trade concerns over the technical barriers to trade in medical devices can be properly solved under the forum of WTO explore possible options for solutions to these TBT issues based on the development of other trade arrangements and international medical device regulatory framework. This artilcle discusses the trade issues on Taiwan’s medicial device regulationsand offers recommendations for futher reforms.
    Analysis of the results showed that because medical devices are related to human life safety, countries take considerable regulatory measures which restrict the free trade of medical devices. In terms of commormity assessment procedures for medical devices, although there is lack of relevant evidence to inadvertently judge the legality of relevant regulatory meausres in specific trade concerns, it can be confirmed that these medical device conformity assessment procedures often cause medical device manufacturers to add repeated trial cost and delay in entering the market; in terms of procedural measures, many countries often fail to notify the TBT Committee and give other Member States an appropriate comment period when formulating or amending commormity assessment procedures for medical devices, and result in a violation of the obligation of transparency. In order to solve the above problems in commormity assessment procedures for medical devices, Member States may use MRA and the equivalence agreement as a solution. IMDFR further propose the MDSAP plan to harmonize the commormity assessment procedures for medical devices in recent year. Looking at the commormity assessment procedures for medical devices, the application for QSD and inspection registration in the pre-market review process will also cause the costs and burdens on foreign medical device manufacturers. Learn from international medical device conformity assessment trade analysis and solution, this study recommended to simplify the pre-examination review process, approve the audit report issued by MDSAP synchronously, reduce technical trade barriers and strengthen international cooperation.
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    Committee on Technical Barriers to Trade, Minutes of The Meeting of 5 July 2007, WTO Doc. G/TBT/M/42 (Aug. 6, 2007).
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    Committee on Technical Barriers to Trade, Notification, WTO Doc. G/TBT/N/CHN/965 (Jun. 4, 2013); Committee on Technical Barriers to Trade, Notification, WTO Doc. G/TBT/N/CHN/966 (Jun. 4, 2013).
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    Committee on Technical Barriers to Trade, Notification on Draft Decision of the Board of the Eurasian Economic Union "On the Establishment of the Rules of Conducting Technical Tests of Medical Devices", WTO Doc. G/TBT/N/RUS/51, (May 10, 2016).
    Committee on Technical Barriers to Trade, Notification on Draft Decision of The Board of the Eurasian Economic Union "On the Rules of Registration and of the Safety, Quality, and Efficiency Inspection of Medical Devices" , WTO Doc. G/TBT/N/RUS/52, (May 10, 2016).
    Committee on Technical Barriers to Trade, Notification on Draft Decision of the Board of the Eurasian Economic Union "On the Establishment of the Common Requirements for Safety and Efficiency of Medical Devices, for their Labelling Requirements and Operational Documentation for Them", WTO Doc. G/TBT/N/RUS/53b(May 10, 2016).
    Committee on Technical Barriers to Trade, Notification on Draft decision of The Board of the Eurasian Economic Union "On the Special Production Mark of Medical Devices on the Market of the Eurasian Economic Union", WTO Doc. G/TBT/N/RUS/55 (May 10, 2016).
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    Panel report, European Communities—Trade Description of Sardine, WTO Doc. WT/DS231/R (adopted May 29, 2002).
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    Panel report, United States — Measures Affecting the Production and Sale of Clove Cigarettes, WTO Doc. WT/DS406/R (adopted Sept. 2, 2011).
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    其他機構文件:
    IMDRF, Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N47 FINAL:2018 (Oct. 31, 2018), http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf.
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    GHTF, The GHTF Regulatory Model, GHTF/AHWG-GRM/N1R13:2011 (Apr. 13, 2011), http://www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf.
    GHTF, Principles of Medical Devices Classification, GHTF/SG1/N15:2006 (June 27, 2006), http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf.
    GHTF, Label and Instructions for Use for Medical Devices, GHTF/SG1/N70:2011 (Sept. 16, 2011), http://www.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n70-2011-label-instruction-use-medical-devices-110916.pdf.
    Medical Device Single Audit Program (MDSAP) Companion Document 2017-01-06 MDSAP AU G0002.1.004.
    ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, THE CONTRIBUTION OF MUTUAL RECOGNITION TO INTERNATIONAL REGULATORY CO-OPERATION 14 (2016), https://www.oecd.org/gov/regulatory-policy/WP2_Contribution-of-mutual-recognition-to-IRC.pdf.
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    網際網路:
    APEC-TEL MRA, ASIA-PACIFIC ECONOMIC COOPERATION, https://www.apec.org/Groups/SOM-Steering-Committee-on-Economic-and-Technical-Cooperation/Working-Groups/Telecommunications-and-Information/APEC_TEL-MRA.aspx (last visited Nov. 24, 2019).
    Creation of Common Markets of Medicines and Medical Products, EURASAIN ECONOMIC COMMISSION, http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Pages/default.aspx (last visited Dec. 3, 2019). Taiwan - Medical Devices, Export.gov, https://www.export.gov/article?id=Taiwan-Medical-Devices (last updated Nov. 8, 2019).
    Edwin Bill, MDSAP — History and Advantages, MED DEVICE ONLINE (Aug. 12, 201), https://www.meddeviceonline.com/doc/mdsap-history-and-advantages-0001.
    GHTF History, INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM [IMDRF], http://www.imdrf.org/ghtf/ghtf-history.asp (last visited Nov. 23, 2019).
    Internal Market, Industry, Entrepreneurship and SMEs of Mutual Recognition Agreement, EUROPEAN COMMISSION, https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=mra.main (last visited Nov. 24, 2019).
    IAF Members & Signatories, INTERNATIONAL ACCREDITATION FORUM, https://www.iaf.nu//articles/IAF_MEMBERS_SIGNATORIES/4 (last visited Dec. 4, 2019).
    IAF/ILAC Recognition, EA EUROPEAN ACCREDITATION, https://european-accreditation.org/mutual-recognition/iaf-ilac-recognition/ (last visited Dec. 4, 2019).
    Medical Devices of Global Harmonization Task Force, WORLD HEALTH ORGANIZATION [WHO], https://www.who.int/medical_devices/collaborations/force/en/ (last visited Nov. 23, 2019).
    Medical Device Single Audit Program (MDSAP), IMDRF, http://www.imdrf.org/workitems/wi-mdsap.asp (last visited Dec. 4, 2019).
    Medical Device Single Audit Program (MDSAP), BSI, https://www.bsigroup.com/en-GB/medical-devices/our-services/Medical-Device-Single-Audit-Program/ (last visited Dec. 4, 2019).
    Mark Durivage, MDSAP`s Effect On The Internal Audit Process, MED DEVICE ONLINE (July 5, 2018), https://www.meddeviceonline.com/doc/mdsap-s-effect-on-the-internal-audit-process-0001.
    Moving to a Single-Audit System: MDSAP Requirements for Medical Device Manufacturers, ISO TRACHER, https://www.isotracker.com/blog/moving-to-a-single-audit-system-mdsap-requirements-for-medical-device-manufacturers/ (last visited Dec. 4, 2019).
    Taiwan - Medical Devices, EXPORT.GOV, https://www.export.gov/article?id=Taiwan-Medical-Devices (last updated Nov. 8, 2019).
    Description: 碩士
    國立政治大學
    國際經營與貿易學系
    106351005
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G1063510051
    Data Type: thesis
    DOI: 10.6814/NCCU202000019
    Appears in Collections:[國際經營與貿易學系 ] 學位論文

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