德国医疗器材登记法规问答集 -

德国医疗器材登记法规问答集

除了提供您审阅德国医疗器材登记法规问题和答案; 永辉关係企业也提供德国医疗器材产品许可证登记服务，协助准备所需的文件和申请过程的跟进与维护。

Email：fra4ww@evershinecpa.com
或
德国永辉BPO有限公司
Frankfurt time zone:
Dr. Chris Wu, 说德文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008 / wechat: annylin8008
电话：+886-2-2717-0515 分机:110

文章目录 点击收合

HLF-DE-10请问德国对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

HLF-DE-020外国公司要到德国销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

HLF-DE-30外国公司要到德国销售医疗器材，可以指派德国公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

HLF-DE-40外国公司销售到德国医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文除了德文外，其他哪种语文也可以？网页？

HLF-DE-50外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文除了德文外，其他哪种语文也可以？网页？

HLF-DE-60经过核准登记的医疗器材，进口到德国要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

HLF-DE-70德国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

HLF-DE-80外国子公司进口医疗器材后，如果委託德国的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

各国医疗器材登记法规问答集

服务范围：
提供德国卫生福利部申请医疗器械许可证的註册服务。
向德国卫生福利部申请医疗器械许可证的续期註册服务。
充当您在医疗器械方面的法规事务顾问。
服务内容：
协助准备註册文件和相关资讯。
提供监管事务的反馈和支持。
被委託处理与相关方的通信和相关工作。
保密条款:
除了政府要求外，我们将对产品内容、豁免方式、公司经营情况等保持保密。

以下是供您审阅的德国医疗器材登记法规问题和答案。

HLF-DE-10
请问德国对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in Germany? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?

答：

1.欧盟将医疗器材分为两大范畴：
1.1医疗器材：
是指单独或组合形式，以一种或多种特定医疗目的用于人类的任何仪器、装置、器具、软件、植入物、试剂、材料或其他物品。
．疾病的诊断、预防、监测、预测、预后、治疗或缓解。
．伤害或残疾的诊断、监测、治疗、减轻或补偿。
．解剖结构、生理或病理过程的调查、替换或修改。
．应用于人体的体外检查，包括器官、血液和组织，并且不能通过药理学、免疫学或代谢方式在人体内或人体内实现其主要预期作用，但可以通过这些医疗器材辅助其功能。
以下产品也应视为医疗器材：
．控制或支持受孕的装置。
．专门用于对医疗器材进行清洁、消毒或灭菌的产品。

1.2.体外诊断医疗器材：
是指单独或组合形式的试剂、试剂产品、校准器、控製材料、试剂盒、仪器、设备、设备、软件或系统的任何医疗器材，用于体外检查来自人体的标本，包括血液和组织。
．与生理或病理过程或状态相关
．与先天性身体或精神障碍相关
．与身体状况或疾病的倾向相关
．与潜在接受者的安全性和兼容性之鑑定
．预测治疗反应
．定义或监测治疗措施
标本容器也应视为体外诊断医疗器材。

2.医疗器材分为以下类别：
. 非侵入式设备
. 侵入性医疗器材
. 有源医疗器材
. 特殊规则（包括避孕、消毒和放射诊断医疗器材）
风险等级由低至高：第I类产品要加贴CE标誌，可採取自行宣告的方式。
第II(a)类、第II(b)类、第III类产品要加贴CE标誌，则必须由欧盟指定的验证机构验证。
1. I 类：非无菌或不具有测量功能（低风险）
2. I 类：无菌和具有测量功能（低/中风险）。
3. IIa 级（中等风险）
4. IIb 类（中/高风险）
5. III 级（高风险）
联邦卫生部辖下的联邦药品和医疗器材研究所 (BfArM) 是德国的医疗器材监管机构。

1.The EU divides medical devices into two categories:
1. 1 Medical device:
refers to any instrument, device, appliance, software, implant, reagent, material or other item, alone or in combination, for use in humans for one or more specific medical purposes.
．Diagnosis, prevention, monitoring, prediction, prognosis, treatment or mitigation of disease.
．Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability.
．Investigation, replacement or modification of anatomical structures, physiological or pathological processes.
．It is applied to the in vitro examination of the human body, including organs, blood and tissues, and cannot achieve its main intended effect in the human body or in the human body by pharmacological, immunological or metabolic means, but its function can be assisted by these medical devices.

The following products shall also be considered medical devices:
．A device that controls or supports conception.
．Products specifically designed to clean, disinfect or sterilize medical devices.

1.2. In-vitro diagnostic medical device:
refers to any medical device in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, equipment, software or systems in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, software or systems, used for in vitro examination of specimens from the human body , including blood and tissue.
．associated with a physiological or pathological process or state
．Associated with a congenital physical or mental disorder
．Associated with physical condition or predisposition to disease
．Identification of safety and compatibility with potential recipients
．predict treatment response
．Define or monitor treatment measures

Specimen containers should also be considered in vitro diagnostic medical devices.

2.The risk level is from low to high:
Class I products need to be affixed with the CE mark, and self-declaration can be adopted.
Class II(a), Class II(b), Class III products to be affixed with the CE mark must be verified by an EU-designated certification body.
1. Class I: Non-sterile or non-measurable (low risk)
2. Class I: Sterile and capable of measuring (low/medium risk).
3. Class IIa (moderate risk)
4. Class IIb (medium/high risk)
5. Class III (High Risk)
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) under the Federal Ministry of Health is Germany’s medical device regulator.

【参考连结】

https://www.bfarm.de/EN/Home/_node.html
https://eur-lex.europa.eu/homepage.html

HLF-DE-020
外国公司要到德国销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in Germany, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

答：

需要于欧盟註册并取得销售当地的销售凭证。
每个经济运营商（欧盟和非欧盟製造商、授权代表、系统/程序包生产商和进口商）都必须先在欧盟设立的网站 EUDAMED 註册为参与者并提供所需信息：
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．识别设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌症
．医疗器材命名法 (CND) 代码等

3.证书和公告机构
．产品类别证书：欧盟型式检验证书、欧盟技术文件证书、欧盟产品验证证书。
．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、欧盟生产质量保证证书。
4.临床调查和性能研究(开发中)
5.警惕和上市后监督(开发中)
6.市场监督(开发中)
并且，若产品是首次在德国投放，必须在相应联邦州的主管部门註册自由销售凭证。
申请是非制式的，但必须以书面形式提出。

申请应说明或包含：
1. 接受国
2. 自由销售凭证基本上是德语，模板设计成两列，首列是德语，第二列是语、法语、葡萄牙语或西班牙语(取决于申请人) 如果未指定语言版本，将颁发德语/英语证书。
3. 收件地址
4. 产品清单
．商品或目录号
．产品名称
．UDI-DI
．更高级别的产品指定机构的证书
5. 显示产品适销性的文件
．I 类：相关的符合性声明
．II(a)类、II(b)类、III类：除了符合性声明外，还需提供一份认证机构的符合性声明的副本。

It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.

2.UDI/device registration
． Manufacturer’s name, address
． Risk level
． Measurement function (yes/no)
． Reusable surgical instruments (yes/no)
． Active device (yes/no)
． Identify the device model
． Technical file or certificate of conformity/declaration
． Equipment Quantity
． unit of use
． clinical scale
． Additional Product Description
． Single use (yes/no)
． Maximum number of reuses
． Does it need to be sterilized?
． Contains latex (yes/no)
． CMR/endocrine disruptor
． Serious Warnings or Contraindications
． Medical Device Nomenclature (CND) codes, etc.

3. Certificates and Notified Bodies
．Product category certificate: EU type inspection certificate, EU technical file certificate, EU product verification certificate.
．Quality certificate: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.

4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)

In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale. Applications are informal but must be made in writing.

The application should state or contain:

1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
．Class I: Relevant Declaration of Conformity
．Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.

【参考连结】

https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Reporting-risks/_node.html
https://ec.europa.eu/
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/

HLF-DE-25

HLF-DE-30
外国公司要到德国销售医疗器材，可以指派德国公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in Germany, can it assign a German company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

答：

可以。需要于欧盟註册并取得销售当地的销售凭证。
每个经济运营商（欧盟和非欧盟製造商、授权代表、系统/程序包生产商和进口商）都必须先在欧盟设立的网站 EUDAMED 註册为参与者并提供所需信息：

1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．识别设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌症
．医疗器材命名法 (CND) 代码等

3.证书和公告机构
．产品类别证书：欧盟型式检验证书、欧盟技术文件证书、欧盟产品验证证书。
．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、欧盟生产质量保证证书。
4.临床调查和性能研究(开发中)
5.警惕和上市后监督(开发中)
6.市场监督(开发中)

当发生不良事件时，下列为负责人(通报及召回)：
1. 设备首次投放市场的负责人：製造商。
2. 若製造商在欧洲经济区没有註册营业地，并且已指定授权代表，则由授权代表负责。
3. 如果医疗器材是由进口商输入欧洲经济区，没有授权代表的情况下，则进口商是负责人。
4. 如果设备是在专业或商业框架内操作或使用，则医疗设备的运营商或用户为负责人。
5. 向患者或其他非专业人士出售医疗器材供个人使用的分销商、贸易商和授权的医疗或牙科人员。
6. 如果是以经销商、进口商或其他自然人或法人的名称、註册商品名称或註册商标在市场上提供设备，除非分销商或进口商与製造商达成协议，製造商在标籤上被识别为製造商并负责满足本法规对製造商的要求，否则商标註册者应当承担製造商应尽的义务。

EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.

4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)

When adverse events occur, the following persons are responsible (notification and recall):
1. The person responsible for the first time the device is placed on the market: the manufacturer.
2. If the manufacturer does not have a registered place of business in the European Economic Area and has appointed an authorised representative, the authorised representative is responsible.
3. If the medical device is imported into the European Economic Area by the importer without an authorized representative, the importer is the responsible person.
4. If the equipment is operated or used in a professional or commercial framework, the operator or user of the medical device is the responsible person.
5. Distributors, traders, and authorized medical or dental personnel who sell medical devices for personal use to patients or other non-professionals.
6. If the device is offered on the market under the name, registered trade name or registered trademark of a distributor, importer or other natural or legal people, unless the distributor or importer has reached an agreement with the manufacturer, the manufacturer is identified on the label as The manufacturer is also responsible for meeting the requirements of this regulation for the manufacturer, otherwise the trademark registrant shall bear the obligations due to the manufacturer.

【参考连结】

https://ec.europa.eu/tools/eudamed/#/screen/home
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
https://www.bfarm.de/EN/Medical-devices/Applications-and-reports/_node.html

HLF-DE-35

HLF-DE-40
外国公司销售到德国医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了德文外，其他哪种语文也可以？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to Germany?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to German, which other languages are allowed? Website?

答：

需要。需要于欧盟註册并取得销售当地的销售凭证。
每个经济运营商（欧盟和非欧盟製造商、授权代表、系统/程序包生产商和进口商）都必须先在欧盟设立的网站EUDAMED 註册为参与者并提供所需信息：
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．识别设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌症
．医疗器材命名法 (CND) 代码等

在德国，首次将医疗器材在德国市场必须在相应联邦州的主管部门註册自由销售。申请是非制式的，但必须以书面形式提出。
申请应说明或包含：

1. 申请者国家
2. 如果适用，说明所需的语言版本：自由销售凭证基本上是德语，模板设计成两列，首列是德语，第二列是语、法语、葡萄牙语或西班牙语(取决于申请人) 如果未指定语言版本，将颁发德语/英语证书。
3.收件地址
4. 产品清单
．商品或目录号
．产品名称
．UDI-DI
．更高级别的产品指定机构的证书
5. 显示产品适销性的文件
．I 类：相关的符合性声明
．II(a)类、II(b)类、III类：除了符合性声明外，还需提供一份认证机构的符合性声明的副本。

标籤和使用说明：
1. 每个产品都必须附有安全使用、识别产品、製造商或授权代表所需的所有安全和性能信息。
2. 在标籤和使用说明方面必须考虑国家语言要求，需使用德语，技术文档中使用说明应使用每种相关国家语言。
3. 标籤应说明该产品是“医疗装置”。
4. 製造商提供的信息须採用国际格式公认的符号。
5. 建议检查翻译，由于不正确或误导性翻译而对患者或其他人造成人身伤害，製造商需要承担责任。

4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)

In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale.
Applications are informal but must be made in writing.

The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
．Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.

Labels and Instructions for Use:
1. Each product must be accompanied by all safety and performance information necessary for safe use, identification of the product, manufacturer or authorized representative.
2. National language requirements must be taken into account with regard to labels and instructions for use in German, and instructions for use in technical documentation should be in each relevant national language.
3. The label should state that the product is a “medical device”.
4. The information provided by the manufacturer shall be in internationally recognized symbols.
5. It is recommended to check the translation, the manufacturer is liable for personal injury to the patient or others due to incorrect or misleading translation.

【参考连结】

https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
https://mdr-ivdr.bio-pro.de/
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/

HLF-DE-45

HLF-DE-50
外国公司可以用自己名义申请办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？
申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了德文外，其他哪种语文也可以？网页？

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required?
What is the application process? Do medical devices packaging and labeling require prior approval?
In addition to German, which other languages are allowed? Website?

答：

EUDAMED 註册为参与者并提供所需信息：

在德国，首次将医疗器材在德国市场必须在相应联邦州的主管部门註册自由销售。申请是非制式的，但必须以书面形式提出。
申请应说明或包含：

If equipment is offered on the EU market under the name, registered trade name or registered trade mark of a distributor, importer or other natural or legal person, unless the distributor or importer has agreed with the manufacturer, the manufacturer is identified on the label as manufacturing Trademark registrants shall be responsible for meeting the requirements of this regulation for manufacturers, otherwise the trademark registrant shall undertake the obligations due to the manufacturer.
Those who register trademarks need to have a registered business place in the European Economic Area, and those who do not have a place of business can appoint an authorized representative.

4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)

The application should state or contain:

1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
． Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.

Labels and Instructions for Use:

1. Each product must be accompanied by all safety and performance information necessary for safe use, identification of the product, manufacturer or authorized representative.
2. National language requirements must be taken into account with regard to labels and instructions for use in German, and instructions for use in technical documentation should be in each relevant national language.
3. The label should state that the product is a “medical device”.
4. The information provided by the manufacturer shall be in internationally recognized symbols.
5. It is recommended to check the translation, the manufacturer is liable for personal injury to the patient or others due to incorrect or misleading translation.

【参考连结】
https://mdr-ivdr.bio-pro.de/
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/

HLF-DE-55

HLF-DE-60
经过核准登记的医疗器材，进口到德国要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into Germany? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

答：

需要于欧盟註册并取得销售当地的销售凭证。
在德国，首次将医疗器材在德国市场必须在相应联邦州的主管部门註册自由销售。
申请是非制式的，但必须以书面形式提出。
申请应说明或包含：
1. 申请者国家
2. 如果适用，说明所需的语言版本：自由销售凭证基本上是德语，模板设计成两列，首列是德语，第二列是语、法语、葡萄牙语或西班牙语(取决于申请人) 如果未指定语言版本，将颁发德语/英语证书。
3.收件地址
4. 产品清单
．商品或目录号
．产品名称
．UDI-DI
．更高级别的产品指定机构的证书
5. 显示产品适销性的文件
．I 类：相关的符合性声明
．II(a)类、II(b)类、III类：除了符合性声明外，还需提供一份认证机构的符合性声明的副本。

贴有 CE 认证标籤的产品可在所有欧洲经济共同体 (简称 EEC) 会员国国内自由贩售，不需经过其他国家产品检测。
欧盟以外地区製造的货品必须具备完整的海关申报书，才能在欧盟市场内自由贩卖。
希望进行贸易的企业和个人在必须在所有海关程序中使用经济经营者註册和识别号 (EORI)作为识别号。
EORI 编号是在整个欧盟范围内有效的运营商识别号，它取代了德国海关编号。
在德国，EORI 编号由德累斯顿海关总局主数据管理办公室 ( GZD – DO Dresden – Stammdatenmanagement ) 分配。

1.总公司名称/公司名称
2.註册成立日期(日/月/年)
3.登记资料
4.地区
5.联繫方式
．电子邮件地址
．电话号码
6. 公司地址
．国家
．邮政编码
．地点
．街道
．区
．地址补充
7. 税务资料
．申请者国家税务局名称
．税号(有/无)
8.联繫人
．全名
．电话号码、传真号码、电子邮件
．街道、门牌号
．国名、国家邮政编码、地址
．税号
．财政代表
．地点、日期
．签名：具有法律约束力的签名和公司印章
．谘询电话

It is necessary to register in the EU and obtain a local sales certificate for sales.
In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale. Applications are informal but must be made in writing.

The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
． Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.

Products bearing the CE label can be sold freely in all European Economic Community (EEC) member states without the need for product testing in other countries.
Goods manufactured outside the EU must have a full customs declaration before they can be freely sold on the EU market.
Businesses and individuals wishing to trade must use the Economic Operator Registration and Identification Number (EORI) as an identification number in all customs procedures.
The EORI number is an EU-wide operator identification number that replaces the German customs number.

In Germany, EORI numbers are assigned by the Master Data Management Office of the General Directorate of Customs in Dresden ( GZD – DO Dresden – Stammdatenmanagement ).
1. Head Office Name/Company Name
2. Date of incorporation (dd/mm/yyyy)
3. Registration Information
4. Region
5. Contact information
． Email address
． Phone number
6. Company address
． Nation
． Zip code
． Place
． Street
． Area
． Address Supplement
7. Tax information
． Applicant’s IRS name
． Tax ID (yes/no)
8. Contacts
． Full name
． Phone number, fax number, email
． Street, house number
． Country name, country postal code, address
． Tax ID
． Financial representative
． Location, date
． Signature: Legally binding signature and company seal
． Telephone number

【参考连结】

https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
https://www.zoll.de/EN/Businesses/Movement-of-goods/Import/Duties-and-taxes/EORI-number/eori-number_node.html;jsessionid=CF30EFB6C8FAE932CD4A46AD63A3F5F9.internet412

HLF-DE-70
德国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

答：

【参考连结】

在欧盟 (EU) 销售医疗器材，产品皆须要取得 CE 标誌：CE 标誌应明显、清晰、不可磨灭地贴在器材或其无菌包装上。
如果由于设备的性质而无法或不能保证这种粘贴，则应在包装上粘贴 CE 标誌。
CE 标誌也应出现在任何使用说明和任何销售包装上。
1. CE 标誌应由以下形式的首字母“CE”组成：

2. 如果CE标誌缩小或放大，应遵守上述刻度图中给出的比例。
3. CE标誌的各个组成部分应具有基本相同的垂直尺寸，不得小于5mm。对于小型设备，可以免除此最小尺寸。

医疗器材依据其分类申请CE认证具备内容：
1. ClassI：自我宣告即可
2. ClassIIa/ClassIIb/ClassIII:须符合相对应之医疗器材指令，通过认证机构评鑑(Notified Body Conformity Assessment Procedure)，取得CE证书。

注意事项：

1. I 类（非无菌、非测量）需要符合上市后监控(PMS) 机制。
．製造商应依器材风险等级和医材分类，规划、建立、文件化、施行、维护与持续更新上市后监督系统，以确认产品生命週期间的安全与功效。
2. 除 I 类（非无菌、非测量）以外的所有设备，需要实施质量管理体系(QMS) 。
．产品在取得认证文件后才可印上CE标誌。製造商、代理或进口商经过内部设立的产品检测部门检测，或会邀请外部的验证机构测试产品实施品质管理，确保量产产品符合检验合格之样品。
3. I 类到 IIb 类，需要一份技术文件，II 类/AIMD 设备为设计档案。
．製造商或任何授权代表的姓名和地址
．产品的简要说明
．产品的标识，例如产品的序列号
．产品设计和製造所涉及的设施的名称和地址
．参与评估产品符合性的任何公告机构的名称和地址
．已遵循的合格评定程序的声明
．欧盟符合性声明
．标籤和使用说明
．产品符合的相关法规的声明
．识别声称符合的技术标准
．零件清单
．试验结果
4. IIa 类、IIb 类和 III 类器材的製造商应为每个器材准备一份定期安全更新报告（“PSUR”），并在与每个类别或器材组相关的情况下，总结后期分析的结果和结论。
5. 欧洲办事处或授权代表的名称和地址放在使用说明、外包装或设备标籤上。
6. 除 I 类（非无菌、非测量）以外的所有设备，其 QMS 和技术文件或设计档案皆必须由认证机构（欧洲当局认可的第三方审核医疗器材公司和产品）进行审核。

The sale of medical devices in the European Union (EU) requires CE marking of products: the CE marking should be conspicuously, clearly and indelibly affixed to the device or its sterile packaging.
If, due to the nature of the equipment, such affixing is not possible or warranted, the CE marking shall be affixed to the packaging.
The CE marking should also appear on any instructions for use and on any sales packaging.
1. The CE marking shall consist of the initials “CE” in the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the scale diagram above shall be observed.
3. The various components of the CE mark shall have substantially the same vertical dimension and shall not be less than 5mm. For small devices, this minimum size can be waived.

Medical devices applying for CE certification according to their classification have the following contents:
1. Class I: self-declaration is enough
2. ClassIIa/ClassIIb/ClassIII: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain the CE certificate.

Precautions:
1. Category I (non-sterile, non-measured) requires compliance with post-market surveillance (PMS) mechanisms.
．Manufacturers should plan, establish, document, implement, maintain and continuously update post-market surveillance systems based on device risk levels and medical material classifications to confirm product safety and efficacy during the product life cycle.
2. All equipment other than Class I (non-sterile, non-measuring) requires the implementation of a quality management system (QMS).
．Products can only be printed with the CE mark after obtaining the certification documents. Manufacturers, agents or importers have been tested by the internal product testing department, or they may invite external verification agencies to test the products to implement quality management to ensure that the mass-produced products meet the samples that have passed the inspection.
3. For Class I to Class IIb, a technical file is required, and Class II/AIMD equipment is a design file.
．The name and address of the manufacturer or any authorized representative
． Brief description of the product
．Identification of the product, such as the product’s serial number
．The name and address of the facility involved in the design and manufacture of the product
．Name and address of any notified body involved in assessing product conformity
． Statement of conformity assessment procedures followed
．EU Declaration of Conformity
．Labels and Instructions for Use
．Statement of relevant regulations to which the product complies
．Identify technical standards claimed to be compliant
．Parts List
．test results
4. Manufacturers of Class IIa, IIb and III devices shall prepare a Periodic Safety Update Report (“PSUR”) for each device and, where relevant to each class or device group, summarizing the results and conclusions.
5. The name and address of the European office or authorized representative are placed on the instructions for use, on the outer packaging or on the device label.
6. For all devices other than Class I (non-sterile, non-measurement), their QMS and technical or design files must be reviewed by a certification body (a third-party audit of medical device companies and products recognized by European authorities).

【参考连结】

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

HLF-DE-75

德国医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

答：

医疗器材的CE认证只有在欧盟网站公告的指定验证机构(欧盟境内)，才具备医疗器材的CE符合性证书发证资格。
The CE certification of medical devices can only be issued by the designated certification body (within the EU) announced on the EU website.

HLF-DE-77

HLF-DE-80
外国子公司进口医疗器材后，如果委託德国的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in Germany to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

答：

需要于欧盟註册并取得销售当地的销售凭证。每个经济运营商（欧盟和非欧盟製造商、授权代表、系统/程序包生产商和进口商）都必须先在欧盟设立的网站： EUDAMED 註册为参与者并提供所需信息。
当发生不良事件时，下列为负责人(通报及召回)：
1. 设备首次投放市场的负责人：製造商。
2. 若製造商在欧洲经济区没有註册营业地，并且已指定授权代表，则由授权代表负责。
3. 如果医疗器材是由进口商输入欧洲经济区，没有授权代表的情况下，则进口商是负责人。
4. 如果设备是在专业或商业框架内操作或使用，则医疗设备的运营商或用户为负责人。
5. 向患者或其他非专业人士出售医疗器材供个人使用的分销商、贸易商和授权的医疗或牙科人员。
6. 如果是以经销商、进口商或其他自然人或法人的名称、註册商品名称或註册商标在市场上提供设备，除非分销商或进口商与製造商达成协议，製造商在标籤上被识别为製造商并负责满足本法规对製造商的要求，否则商标註册者应当承担製造商应尽的义务。

It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
When adverse events occur, the following persons are responsible (notification and recall):
1. The person responsible for the first time the device is placed on the market: the manufacturer.
2. If the manufacturer does not have a registered place of business in the European Economic Area and has appointed an authorised representative, the authorised representative is responsible.
3. If the medical device is imported into the European Economic Area by the importer without an authorized representative, the importer is the responsible person.
4. If the equipment is operated or used in a professional or commercial framework, the operator or user of the medical device is the responsible person.
5. Distributors, traders, and authorized medical or dental personnel who sell medical devices for personal use to patients or other non-professionals.
6. If the device is offered on the market under the name, registered trade name or registered trademark of a distributor, importer or other natural or legal people, unless the distributor or importer has reached an agreement with the manufacturer, the manufacturer is identified on the label as The manufacturer is also responsible for meeting the requirements of this regulation for the manufacturer, otherwise the trademark registrant shall bear the obligations due to the manufacturer.

【参考连结】

HLF-DE-85

各国医疗器材登记法规问答集

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全球永辉服务据点参考资料:
永辉100%子公司：
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。

其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所.总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

更多城市更多服务请点击网站导览

除了提供外资公司登记外，在云会计和薪资系统的支持下,永辉担任贵司在德国子公司内部会计角色，承担了会计,薪资, 税务,法规遵循等一站式服务。德国同事携手协同为您服务，减少空中旅行，为地球暖化尽一份心力。

德国主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支持的会计薪资服务。德国与台湾同事携手协同为您服务。为地球暖化尽一份心力，减少空中旅行。

台湾及德国同事协同为您服务。协助远程控管德国员工考勤状况。符合劳动法规，税务法规。远程云端作业，克服台籍派不出去的困难。
使用云端薪资与考勤系统支持，提供人事基本数据维护，薪资数据维护，请假单，加班单，GPS打卡，排班，薪资计算，薪资支付，薪资查询等作业。

网络系统支持+网络银行借着云端会计系统提供协同作业的工作环境,我们扮演如同贵公司的内部会计角色,虽然永辉同事并未在贵公司上班.
贵公司采用我们的四合一服务，除了贵公司担任财务调度之高阶主管外, 甚至于不必雇请基层会计人员、出纳人员、薪资处理人员、以及信息人员。