MEDICAL DEVICE
QUESTIONNAIRE
医疗器械认证---问卷调查表
Completion Guidance Notes 填表指引:
1. In order for SGS to be able to give you an accurate quotation for audit services it is important that we identify the scope of the service to be audited. 为便于SGS能为你提供更准确的审核报价方案，请务必定义清楚预期审核服务的范围。
2. Please answer the enclosed questions as fully as possible, if you do not know the answer to any question please type "don't know" and one of our technical team will contact you to discuss.请尽可能详尽地回答本卷中的问题(请尽量用English或English + Chinese填写), 如果某问题不会回答，请写上’不清楚’, SGS的技术团队会与你联络讨论相关事项。
3. If you have more than one site to be audited, please provide a list of the site addresses to be included in the scope, and the activities at each site.如果你的审核范围内有不止一个审核地址,请在本表的第3部分或另外附表中列清楚每个地址，及该地址的人数与相关活动(如设计、采购、注塑、装配、检测、销售等)。
4. We may also need to contact you for clarification of your answers so please ensure that you enter your contact details.我们可能会与你联系以进一步明确相关情况，请务必留下详细可靠的。
5. On receipt of the completed Questionnaire, SGS will prepare and submit a No Obligation proposal detailing the assessment, certification and other costs, and will be followed up by your local Client Manager. 当收到完整的问卷调查表后,SGS国际认证服务部客服经理将当即准备并发出一份详细的初步报价建议书,其中包括评审,认证及其它费用说明。
6. If you are an existing client applying for additional certification please indicate the additions only.  For extensions to scope to existing certification please use SGS Notification forms. . 如果您是SGS认证过的客户而申请新的认证时, 只需列明拟增加的信息。如仅变更现有认证范围时请用SGS的质量体系变更通报表(需要时，SGS的客服人员会予以提供)。
7. Please return in electronic format or hard copy to your local SGS certification office as shown below. 请将完成的电子版或书面版的问卷调查表发回贵司当地的SGS认证办公室。（有任何问题请咨询SGS客服人员）
             
             
             
or centrally to HK.CN.MDDHUB@sgs  or  sgsprodcert@sgs  or  Fax +44 (0)1934 522137
或者集中返回到HK.CN.MDDHUB@sgs  或  sgsprodcert@sgs或传真到 +44 (0)1934 522137
Section 1 :  Contact Information 第1部分: 联系信息
Company name (Legal Entity) :                    公司名称（法人实体）
     
If company is part of a group, please specify  : 如果公司是某集团的子公司,请说明
     
Website :
     
Company VAT (TVA) Number :        公司的增值税号
     
Main Address :
     
(Certification Address)
     
主要地址(认证地址)
     
     
Contact Name : 联系人姓名
     
Position : 部门/ 职务
     
E-mail :
     
Tel No: 电话
     
Fax No: 传真
     
If different from above, Name of person completing this form : 填表人（如果不是上述联系人）姓名
     
Phone number of person completing this form : 填表人（如果不是上述联系人）电话
     
E-mail :
     
Section 2 : The Services you wish to receive from us 第2部分: 希望SGS提供何种服务
(注:  SGS可以在提供一站式整合服务,包括多个认证项目、检测、培训等,有效节约你的时间与财务成本,请浏览网页 dicaldevices.sgs/certification.htm了解更多医疗器械服务信息 。)
注: 在适用的选项后双击鼠标就可标记
ISO 9001: 2008  Quality－ ISO9001:2008质量管理体系 (注: 适于医疗器械及非医疗器械等所有行业)
ISO 13485: 2003 (UKAS Accredited)－UKAS认可的ISO13485:2003 (注: 仅适于医疗器械相关行业)
ISO 13485: 2003 under CMDCAS (Canada)－加拿大医疗器械符合评价体系(CMDCAS）所要求的ISO1348:2003 (注: 适于预计(或已经)在加拿大销售的Class II,III 或IV类医疗器械)
Taiwan approval under the TCP－台湾技术合作计划(TCP)上市批准项目 (注: 适于预计(或已经)在台湾销售的医疗器械－通常是欧盟制造商才适用)
Japanese approval under JPAL－按照日本药事法上市批准项目(注: 适于预计(或已经)在日本销售的医疗器械－通常是日本进口商MAH才适用)
Site Inspection on behalf of FDA (21CFR Part 820)  - only applies where the FDA require that there must be a site inspection) － 代表FDA实施21CFR820现场检查 (注:当FDA要求检查时)
MDACS - Hong Kong medical device regulatory assessment scheme －香港医疗器械合规性评审项目
Directive 93/42/EEC for CE Marking of medical devices - please choose only one conformity route for your certification欧盟医疗器械指令93/42/EEC有关的CE标志  (请只选择一种适当的符合性评价程序)
Annex II  (Full Quality Assurance System)－ 附录II（全面质量保证体系）
Annex V  (Production Quality Assurance) －附录V（生产质量保证体系）
Annex VI  (Product Quality Assurance) －附录VI（产品质量保证体系）
Annex V  (For sterility of Class 1 products)－ 附录V (第I类无菌医疗器械)
Annex V  (For sterility under Article 12) －附录V（第12条款中提及的无菌医疗器械）
Annex V or VI  (For metrology of Class 1 products) －附录V或VI（有测量功能的第I类医疗器械）
Annex IV  (EC Verification - batch or 100% testing by SGS)－ 附录IV（EC验证-SGS批次或100%检测）
Directive 98/79/EC for CE Marking of IVD medical devices - please choose only one conformity route for your certification : 欧盟体外诊断医疗器械指令98/79/EC有关的CE标志(请只选择一种适当的符合性评价程序)
Annex IV  (Full Quality Assurance System) 附录IV（全面质量保证体系）
Annex VII  (Production Quality Assurance)  附录VII（生产质量保证体系）
Annex III  (Design examination for Self-Test devices only) 附录III（自我检测用IVD之设计审查）
If you do not see the standard you require in the list above please indicate : 如果上表中没能详尽列出你所希望的其它认证标准，请指出
     
SGS offers optional services to support you, if you would like more information please indicate : SGS还可以提供其它服务方案,如果有需要,请指出
Pre-Assessment / Gap Analysis  预审/差距分析
Training courses培训         
Testing for this or other medical devices? 医疗器械检测
Section 3 : About your Organisation 第3部分: 贵公司的信息
Are your systems integrated? 贵司的体系是整合体系吗？
No(无)    Partially(部分)    Fully(全部) 
Total number of employees in the organisation? 组织人员总数
     
Total number of employees in the activities to be certified ? 拟申请的认证范围内的人员总数
     
Please list the main processes or activities to be covered by the certification: 请列出审核现场涵盖的主要过程或活动(如业务/生产流程)
     
Do you have design responsibility? 是否有设计责任
Yes          No         
If the company operates a shift system, please indicate the number of employees per shift and a descriptions of the activities per shift : 如果公司倒班/转班的情况，请明确每班次的人数和每班的主要活动。(比如注塑车间3班倒，每班20人。)
     
Do you conduct any activities off site during daytime working hours?  please provide details :正常工作时间内是否有非现场的相关活动，如有，请明确。
     
Locations / Multi-site certification 多地址认证
How many additional sites addresses will be covered by the certification? : 有几个地址包含在本认证范围内？
     
Please provide a brief description of activities at each site or group of sites : 请列明每个地址及该地址的人数与相关活动(如设计、采购、注塑、装配、检测、销售等)。
     
For an accurate quote, please provide the list of site addresses (or provide as a separate page)  : 为更准确报价, 请给个清单,列明每个地址及活动（可以另附一份表格来说明）
     
Scope of certification 认证范围
If you have a specific scope statement then please indicate : 如果特定的认证范围描述，请明确（如Design and manufacture of compressor nebulizer used for conscious patients.）
ISO 9001: 2008
     
ISO13485: 2003
     
Additional Information补充信息
Which other certification / registrations does your company hold (if any) ?: 贵司是否持有其它认证或注册证书？
     
If you have used or intended to use Consultancy Services for the design of your quality management system please provide details :是否曾经或打算使用顾问服务帮助建立质量管理体系，如有，请注明顾问公司的名称和/或顾问的。
     
Do you have a dedicated SGS contact (e.g. Client Manager) ?  If so, please provide their name : SGS是否为贵司指定了专门的客服人员？如有，请指明其姓名。
     
Does SGS currently provide you with any other services ?  If yes, please provide details : 如果贵司现在享用SGS提供的其它服务，请列明
     
Section 4 : Medical Devices information 第4部分: 医疗器械信息
In what language is your device technical documentation ? 技术文档是何种语言文字书写的？（如English/ Chinese）
     
In what language are your quality system procedures ? 质量体系程序文件是何种语言文字书写的？
     
Do you want to transfer any medical device or quality system certification?
If yes, please provide copies 是否希望转换产品或质量体系的认证机构，然则请提供证书现有副本。
Yes
No
Date of last audit  最近一次审核的日期是：     
Expected date of next audit 预期下次审核日期是：        
Reason for transfer to SGS（为何要转到SGS）:  Cost(成本)    Service（服务质量）    Range of certification（认证机构的资质范围）    original body ceased operation （原认证机构业务停止） 
Other（其它原因） :       
Do you design software (stand alone or embedded) that is used to control your devices ? 是否开发计算机软件(独立软件或嵌入式软件) 用于控制医疗器械?
Yes
No
Do your devices incorporate animal material or derivatives (e.g. gelatine, collagen)? 医疗器械里是否使用动物材料或动物材料衍生物（例如：胶质，胶原质）
Yes
No
Do your devices incorporate medicinal products or pharmaceuticals? 医疗器械中是否联合药品或药物一起使用？
Yes
No
Do you undertake any operations within a controlled environment or clean-room? 是否有在受控环境或洁净室完成的任何操作？
Yes
No
Do you supply devices in a sterile condition? 贵司提供的是否是无菌产品？
Yes
No
If you operate sterilization processes on site please give details of the types of processes:如果贵司有灭菌过程,请描述灭菌过程的类型？
     
If you sell other companies medical devices under your own name (own brand labelling), please give details of product ranges and names & addresses of original manufacturers (OEM): 如果贵司以自己的名义（自有品牌）销售其他公司的产品, 请给出OEM的产品范围、名称和地址（最好能提供OEM的证书复印件）。
     
     
     
If you use a sterilization sub-contractor please give name & address of the sub-contractor, the types of processes and details of their certification or approvals: 如果有灭菌的分包方，请提供灭菌分包方的名称和地址、灭菌过程的类型和该分包方持有的证书或批准。
     
     
If there are any other outsourced processes critical to the product please give the sub-contractor names and details of outsourced process or activity: 如果有与产品相关的其它关键的分包过程，请提供分包方的名称和分包过程或活动的情况。
     
     
SGS will assume that all your critical sub-contractors and suppliers have appropriate certification or control for the activities they provide for you, and that no additional audit time is needed to assess them.  SGS暂假定你的关键分包方和供应商持有适当的证书或对其提供活动有充分地管控。
If they do not, please provide details : 如果没有，请提供相关情况：
     
     
Please use an additional page if required必要时可使用附加页
Product information 产 品信息
ISO 13485 certification under CMDCAS only－申请加拿大医疗器械符合评价体系(CMDCAS）所要求的ISO1348:2003时填写
Define range of products sold or to be sold in Canada 请描述已经或预期在加拿大销售的医疗器械的范围（名称及风险分类）
     
     
Site inspection on behalf of FDA only －申请由SGS代表美国FDA实施21CFR820现场审核时填写
Define range of products sold or to be sold in USA, 请描述已经或预期在美国销售的医疗器械的范围
     
     
Taiwan approval under TCP only－申请由SGS按照台湾技术合作计划(TCP) 审核时填写
Define range of products sold or to be sold in Taiwan请描述已经或预期在台湾销售的医疗器械的范围
     
     
Japanese approval under JPAL only－申请由SGS按照按照日本药事法上市批准审核时填写
Define range of products sold or to be sold in Japan请描述已经或预期在日本销售的医疗器械的范围
     
     
Products to be certified under Medical Devices Directive 93/42/EEC包含在医疗器械指令93/42/EEC中预期认证的产品 (CE认证)
Technical File
Name / Number          技术文件名称 / 编号
Device name and description
医疗器械名称和描述（包括预期用途）
Classification
Class I (measuring or sterile),
Class IIa, IIb, III
分类I(Im/Is) IIa,IIb或III
GMDN Number
(Class IIb, III)
NBOG Number (Class IIa)
GMDN 编号（IIb/ III类）
或 NBOG编号（IIa类）
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     如何制作网页版调查问卷
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
Please use additional page if necessary必要时可使用附加页
Note : NBOG codes can be found at  www.nbog.eu/resources/NBOG_BPG_2009_3.pdf NBOG 编号可以在此链接中获取。

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