医疗仪器规管架构建议.DOC

1、1醫療儀器規管架構建議 Proposed Framework on Statutory Control of Medical Devices(問卷 Questionnaire)請於 2010 年 9 月 30 日前將這問卷交回醫療儀器管制辦公室 (傳真: 3157 1286; 電郵: mdcodh.gov.hk; 地址: 香港灣仔皇后大道東 183 號合和中心 31 樓 3101 室)Please return this questionnaire to the Medical Device Control Office by 30 September 2010 (Fax: 3157 1286

2、; Email: mdcodh.gov.hk; Address: Rm. 3101, 31/F., Hopewell Centre, 183 Queens Road East, Wanchai, Hong Kong)姓名 Name :機構名稱 Organisation:業務性質 Nature of business:(可選擇多於一項)(can tick more than one box) 本地負責人 /代理人 Local Responsible Person / Agent 進口商 / 出口商 importer/exporter 分銷商 / 批發商 distributor / wholesa

3、ler 零售商 retailer 本地製造商 local manufacturer 其他 (請說明) others (please specify):地址 Address:電話號碼 Tel No:傳真號碼 Fax No:電郵地址 Email:請在適當的方格內劃上 號，以表達對下述說法的意見。Please indicate your view on the following statements by ticking the appropriate box.同意 不同意 無意見Agree Disagree No Comment1. 政府應立法對醫療儀器進行監管，以確保公眾安全。 The gov

4、ernment should regulate medical devices to ensure public safety through legislation.2. 我/本機構知道政府正推行一套醫療儀器行政管理制度。 I am/My organization is aware that the government is implementing a MedicalDevice Administrative Control System (MDACS).轉下頁 Turn page2同意 不同意 無意見Agree Disagree No Comment3. 大體而言，政府建議的規管架構可

5、以接受。 In general, the regulatory framework proposed by the government is acceptable.4. 在將來的法規中， 授權代表將會取代在現有醫療儀器行政管理制度下的本地負責人 。 The term “Authorized Representatives” is used in the future legislation to replace the term “Local Responsible Persons” under the MDACS.5. 分銷商必須向衞生署註冊,及遵守一套註冊條件。 Distributors

6、 are required to register with the Department of Health and to comply with a set of conditions for registration 6. 進口商/出口商須要為某些指定的高風險或容易被誤用的醫療儀器領取進口 /出口許可證。 Importers/exporters of medical devices are required to obtain import /export licences for specified medical devices that are of high risk or ma

7、y be subject to misuse.7. 其他意見:Other comments:完END3個人資料( 私隱)條例用途聲明1. 收集資料的目的你與衞生署溝通互動時所提供的個人資料，會用於衞生署作為行政及/ 或立法規管醫療儀器的用途。2. 資料轉介人的類別你所提供的個人資料，衞生署主要作內部用途，但也可能於有所需要時因以上第 1 段所列目的或有關事項向其他政策局/部門，或有關方 面披露。此外，該等資料只可於你同意作出該種披露或作出該種披露是個人資料(私隱 )條例所允許的情況下，才向其他方披露。3. 查閱個人資料根據個人資料（私隱）條例第 18 條及 22 條以及附表 1 第 6 原則所

8、述，你有權查閱及修正個人資料，包括有權取得你於以上第 1 段所述的情況下所提供的個人資料。因應查閱資料要求而提供資料時，衞生署可能要徵收費用。4. 查詢就已提供的個人資料的查詢，包括索閱或更改資料，可向衞生署醫療儀器管制辦公室 (香港灣仔皇后大道東 183 號合和中心 31 樓 3101 室，傳真號碼3157 1286，電話號碼：3107 8484) 提出。Personal Data (Privacy) OrdinanceStatement of Purposes1. Purpose of CollectionThe personal data that are provided by you

9、 with whom the Department of Health (DH) interacts will be used by the DH for the purposes of administrative and/or statutory control of medical devices.2. Classes of TransfereesThe personal data that you provide are mainly for use within the DH but it may also be disclosed to other Government burea

10、ux/departments or relevant parties for the purposes mentioned in para. 1 above, and related matters if required. Apart from this, the data may only be disclosed to parties where you have given consent to such disclosure or where it is allowed under the Personal Data (Privacy) Ordinance.3. Access to

11、Personal DataYou have a right of access and correction with respect to personal data as provided for in sections 18 and 22 and Principle 6 of Schedule 1 of the Personal Data (Privacy) Ordinance. Your right of access includes the right to obtain a copy of your personal data. A fee may be imposed for

12、complying with a data access request.4. EnquiriesEnquiries concerning the personal data provided, including the making of access and corrections, should be addressed to the Medical Device Control Office, Department of Health (31/F., Hopewell Centre, 183 Queens Road East, Wanchai, Hong Kong; fascimile number: 3157 1286; telephone number: 3107 8484).