德國醫療器材登記法規問答集 -

德國醫療器材登記法規問答集

除了提供您審閱德國醫療器材登記法規問題和答案; 永輝關係企業也提供德國醫療器材產品許可證登記服務，協助準備所需的文件和申請過程的跟進與維護。

Email：fra4ww@evershinecpa.com
或
德國永輝BPO有限公司
Frankfurt time zone:
Dr. Chris Wu, 說德文中文和英文
或
China Time Zone:
聯絡人: 陳中成總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
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Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

文章目錄 點擊收合

HLF-DE-10請問德國對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

HLF-DE-020外國公司要到德國銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

HLF-DE-30外國公司要到德國銷售醫療器材，可以指派德國公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

HLF-DE-40外國公司銷售到德國醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文除了德文外，其他哪種語文也可以？網頁？

HLF-DE-50外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文除了德文外，其他哪種語文也可以？網頁？

HLF-DE-60經過核准登記的醫療器材，進口到德國要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

HLF-DE-70德國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-DE-80外國子公司進口醫療器材後，如果委託德國的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

各國醫療器材登記法規問答集

服務範圍：
提供德國衛生福利部申請醫療器械許可證的註冊服務。
向德國衛生福利部申請醫療器械許可證的續期註冊服務。
充當您在醫療器械方面的法規事務顧問。
服務內容：
協助準備註冊文件和相關資訊。
提供監管事務的反饋和支持。
被委託處理與相關方的通信和相關工作。
保密條款:
除了政府要求外，我們將對產品內容、豁免方式、公司經營情況等保持保密。

以下是供您審閱的德國醫療器材登記法規問題和答案。

HLF-DE-10
請問德國對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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.歐盟將醫療器材分為兩大範疇：
1.1醫療器材：
是指單獨或組合形式，以一種或多種特定醫療目的用於人類的任何儀器、裝置、器具、軟件、植入物、試劑、材料或其他物品。
．疾病的診斷、預防、監測、預測、預後、治療或緩解。
．傷害或殘疾的診斷、監測、治療、減輕或補償。
．解剖結構、生理或病理過程的調查、替換或修改。
．應用於人體的體外檢查，包括器官、血液和組織，並且不能通過藥理學、免疫學或代謝方式在人體內或人體內實現其主要預期作用，但可以通過這些醫療器材輔助其功能。
以下產品也應視為醫療器材：
．控制或支持受孕的裝置。
．專門用於對醫療器材進行清潔、消毒或滅菌的產品。

1.2.體外診斷醫療器材：
是指單獨或組合形式的試劑、試劑產品、校準器、控製材料、試劑盒、儀器、設備、設備、軟件或系統的任何醫療器材，用於體外檢查來自人體的標本，包括血液和組織。
．與生理或病理過程或狀態相關
．與先天性身體或精神障礙相關
．與身體狀況或疾病的傾向相關
．與潛在接受者的安全性和兼容性之鑑定
．預測治療反應
．定義或監測治療措施
標本容器也應視為體外診斷醫療器材。

2.醫療器材分為以下類別：
. 非侵入式設備
. 侵入性醫療器材
. 有源醫療器材
. 特殊規則（包括避孕、消毒和放射診斷醫療器材）
風險等級由低至高：第I類產品要加貼CE標誌，可採取自行宣告的方式。
第II(a)類、第II(b)類、第III類產品要加貼CE標誌，則必須由歐盟指定的驗證機構驗證。
1. I 類：非無菌或不具有測量功能（低風險）
2. I 類：無菌和具有測量功能（低/中風險）。
3. IIa 級（中等風險）
4. IIb 類（中/高風險）
5. III 級（高風險）
聯邦衛生部轄下的聯邦藥品和醫療器材研究所 (BfArM) 是德國的醫療器材監管機構。

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.

【參考連結】

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

HLF-DE-020
外國公司要到德國銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：

需要於歐盟註冊並取得銷售當地的銷售憑證。
每個經濟運營商（歐盟和非歐盟製造商、授權代表、系統/程序包生產商和進口商）都必須先在歐盟設立的網站 EUDAMED 註冊為參與者並提供所需信息：
1.角色註冊(製造商/授權代表/進口商)
．公司名稱/申請人名稱
．聯繫電話、Email
．國家、城市、街道、郵遞區號等
2.UDI/設備註冊
．製造商名稱、地址
．風險等級
．測量功能(是/否)
．可重複用的手術器材(是/否)
．有源設備(是/否)
．識別設備型號
．技術文件或合格證書/聲明
．設備數量
．使用單位
．臨床規模
．附加產品說明
．一次性使用(是/否)
．最大重複使用次數
．是否需要滅菌
．含乳膠(是/否)
．CMR/內分泌干擾物
．嚴重警告或禁忌症
．醫療器材命名法 (CND) 代碼等

3.證書和公告機構
．產品類別證書：歐盟型式檢驗證書、歐盟技術文件證書、歐盟產品驗證證書。
．質量等級證書：歐盟質量管理體系證書、歐盟質量保證證書、歐盟生產質量保證證書。
4.臨床調查和性能研究(開發中)
5.警惕和上市後監督(開發中)
6.市場監督(開發中)
並且，若產品是首次在德國投放，必須在相應聯邦州的主管部門註冊自由銷售憑證。
申請是非制式的，但必須以書面形式提出。

申請應說明或包含：
1. 接受國
2. 自由銷售憑證基本上是德語，模板設計成兩列，首列是德語，第二列是語、法語、葡萄牙語或西班牙語(取決於申請人) 如果未指定語言版本，將頒發德語/英語證書。
3. 收件地址
4. 產品清單
．商品或目錄號
．產品名稱
．UDI-DI
．更高級別的產品指定機構的證書
5. 顯示產品適銷性的文件
．I 類：相關的符合性聲明
．II(a)類、II(b)類、III類：除了符合性聲明外，還需提供一份認證機構的符合性聲明的副本。

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.

【參考連結】

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
外國公司要到德國銷售醫療器材，可以指派德國公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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。需要於歐盟註冊並取得銷售當地的銷售憑證。
每個經濟運營商（歐盟和非歐盟製造商、授權代表、系統/程序包生產商和進口商）都必須先在歐盟設立的網站 EUDAMED 註冊為參與者並提供所需信息：

1.角色註冊(製造商/授權代表/進口商)
．公司名稱/申請人名稱
．聯繫電話、Email
．國家、城市、街道、郵遞區號等
2.UDI/設備註冊
．製造商名稱、地址
．風險等級
．測量功能(是/否)
．可重複用的手術器材(是/否)
．有源設備(是/否)
．識別設備型號
．技術文件或合格證書/聲明
．設備數量
．使用單位
．臨床規模
．附加產品說明
．一次性使用(是/否)
．最大重複使用次數
．是否需要滅菌
．含乳膠(是/否)
．CMR/內分泌干擾物
．嚴重警告或禁忌症
．醫療器材命名法 (CND) 代碼等

3.證書和公告機構
．產品類別證書：歐盟型式檢驗證書、歐盟技術文件證書、歐盟產品驗證證書。
．質量等級證書：歐盟質量管理體系證書、歐盟質量保證證書、歐盟生產質量保證證書。
4.臨床調查和性能研究(開發中)
5.警惕和上市後監督(開發中)
6.市場監督(開發中)

當發生不良事件時，下列為負責人(通報及召回)：
1. 設備首次投放市場的負責人：製造商。
2. 若製造商在歐洲經濟區沒有註冊營業地，並且已指定授權代表，則由授權代表負責。
3. 如果醫療器材是由進口商輸入歐洲經濟區，沒有授權代表的情況下，則進口商是負責人。
4. 如果設備是在專業或商業框架內操作或使用，則醫療設備的運營商或用戶為負責人。
5. 向患者或其他非專業人士出售醫療器材供個人使用的分銷商、貿易商和授權的醫療或牙科人員。
6. 如果是以經銷商、進口商或其他自然人或法人的名稱、註冊商品名稱或註冊商標在市場上提供設備，除非分銷商或進口商與製造商達成協議，製造商在標籤上被識別為製造商並負責滿足本法規對製造商的要求，否則商標註冊者應當承擔製造商應盡的義務。

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.

【參考連結】

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
外國公司銷售到德國醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了德文外，其他哪種語文也可以？網頁？

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。需要於歐盟註冊並取得銷售當地的銷售憑證。
每個經濟運營商（歐盟和非歐盟製造商、授權代表、系統/程序包生產商和進口商）都必須先在歐盟設立的網站EUDAMED 註冊為參與者並提供所需信息：
1.角色註冊(製造商/授權代表/進口商)
．公司名稱/申請人名稱
．聯繫電話、Email
．國家、城市、街道、郵遞區號等
2.UDI/設備註冊
．製造商名稱、地址
．風險等級
．測量功能(是/否)
．可重複用的手術器材(是/否)
．有源設備(是/否)
．識別設備型號
．技術文件或合格證書/聲明
．設備數量
．使用單位
．臨床規模
．附加產品說明
．一次性使用(是/否)
．最大重複使用次數
．是否需要滅菌
．含乳膠(是/否)
．CMR/內分泌干擾物
．嚴重警告或禁忌症
．醫療器材命名法 (CND) 代碼等

在德國，首次將醫療器材在德國市場必須在相應聯邦州的主管部門註冊自由銷售。申請是非制式的，但必須以書面形式提出。
申請應說明或包含：

1. 申請者國家
2. 如果適用，說明所需的語言版本：自由銷售憑證基本上是德語，模板設計成兩列，首列是德語，第二列是語、法語、葡萄牙語或西班牙語(取決於申請人) 如果未指定語言版本，將頒發德語/英語證書。
3.收件地址
4. 產品清單
．商品或目錄號
．產品名稱
．UDI-DI
．更高級別的產品指定機構的證書
5. 顯示產品適銷性的文件
．I 類：相關的符合性聲明
．II(a)類、II(b)類、III類：除了符合性聲明外，還需提供一份認證機構的符合性聲明的副本。

標籤和使用說明：
1. 每個產品都必須附有安全使用、識別產品、製造商或授權代表所需的所有安全和性能信息。
2. 在標籤和使用說明方面必須考慮國家語言要求，需使用德語，技術文檔中使用說明應使用每種相關國家語言。
3. 標籤應說明該產品是“醫療裝置”。
4. 製造商提供的信息須採用國際格式公認的符號。
5. 建議檢查翻譯，由於不正確或誤導性翻譯而對患者或其他人造成人身傷害，製造商需要承擔責任。

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.

【參考連結】

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
外國公司可以用自己名義申請辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？
申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了德文外，其他哪種語文也可以？網頁？

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 註冊為參與者並提供所需信息：

在德國，首次將醫療器材在德國市場必須在相應聯邦州的主管部門註冊自由銷售。申請是非制式的，但必須以書面形式提出。
申請應說明或包含：

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.

【參考連結】
https://mdr-ivdr.bio-pro.de/
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/

HLF-DE-55

HLF-DE-60
經過核准登記的醫療器材，進口到德國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：

需要於歐盟註冊並取得銷售當地的銷售憑證。
在德國，首次將醫療器材在德國市場必須在相應聯邦州的主管部門註冊自由銷售。
申請是非制式的，但必須以書面形式提出。
申請應說明或包含：
1. 申請者國家
2. 如果適用，說明所需的語言版本：自由銷售憑證基本上是德語，模板設計成兩列，首列是德語，第二列是語、法語、葡萄牙語或西班牙語(取決於申請人) 如果未指定語言版本，將頒發德語/英語證書。
3.收件地址
4. 產品清單
．商品或目錄號
．產品名稱
．UDI-DI
．更高級別的產品指定機構的證書
5. 顯示產品適銷性的文件
．I 類：相關的符合性聲明
．II(a)類、II(b)類、III類：除了符合性聲明外，還需提供一份認證機構的符合性聲明的副本。

貼有 CE 認證標籤的產品可在所有歐洲經濟共同體 (簡稱 EEC) 會員國國內自由販售，不需經過其他國家產品檢測。
歐盟以外地區製造的貨品必須具備完整的海關申報書，才能在歐盟市場內自由販賣。
希望進行貿易的企業和個人在必須在所有海關程序中使用經濟經營者註冊和識別號 (EORI)作為識別號。
EORI 編號是在整個歐盟範圍內有效的運營商識別號，它取代了德國海關編號。
在德國，EORI 編號由德累斯頓海關總局主數據管理辦公室 ( GZD – DO Dresden – Stammdatenmanagement ) 分配。

1.總公司名稱/公司名稱
2.註冊成立日期(日/月/年)
3.登記資料
4.地區
5.聯繫方式
．電子郵件地址
．電話號碼
6. 公司地址
．國家
．郵政編碼
．地點
．街道
．區
．地址補充
7. 稅務資料
．申請者國家稅務局名稱
．稅號(有/無)
8.聯繫人
．全名
．電話號碼、傳真號碼、電子郵件
．街道、門牌號
．國名、國家郵政編碼、地址
．稅號
．財政代表
．地點、日期
．簽名：具有法律約束力的簽名和公司印章
．諮詢電話

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

【參考連結】

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
德國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

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

答：

【參考連結】

在歐盟 (EU) 銷售醫療器材，產品皆須要取得 CE 標誌：CE 標誌應明顯、清晰、不可磨滅地貼在器材或其無菌包裝上。
如果由於設備的性質而無法或不能保證這種粘貼，則應在包裝上粘貼 CE 標誌。
CE 標誌也應出現在任何使用說明和任何銷售包裝上。
1. CE 標誌應由以下形式的首字母“CE”組成：

2. 如果CE標誌縮小或放大，應遵守上述刻度圖中給出的比例。
3. CE標誌的各個組成部分應具有基本相同的垂直尺寸，不得小於5mm。對於小型設備，可以免除此最小尺寸。

醫療器材依據其分類申請CE認證具備內容：
1. ClassI：自我宣告即可
2. ClassIIa/ClassIIb/ClassIII:須符合相對應之醫療器材指令，通過認證機構評鑑(Notified Body Conformity Assessment Procedure)，取得CE證書。

注意事項：

1. I 類（非無菌、非測量）需要符合上市後監控(PMS) 機制。
．製造商應依器材風險等級和醫材分類，規劃、建立、文件化、施行、維護與持續更新上市後監督系統，以確認產品生命週期間的安全與功效。
2. 除 I 類（非無菌、非測量）以外的所有設備，需要實施質量管理體系(QMS) 。
．產品在取得認證文件後才可印上CE標誌。製造商、代理或進口商經過內部設立的產品檢測部門檢測，或會邀請外部的驗證機構測試產品實施品質管理，確保量產產品符合檢驗合格之樣品。
3. I 類到 IIb 類，需要一份技術文件，II 類/AIMD 設備為設計檔案。
．製造商或任何授權代表的姓名和地址
．產品的簡要說明
．產品的標識，例如產品的序列號
．產品設計和製造所涉及的設施的名稱和地址
．參與評估產品符合性的任何公告機構的名稱和地址
．已遵循的合格評定程序的聲明
．歐盟符合性聲明
．標籤和使用說明
．產品符合的相關法規的聲明
．識別聲稱符合的技術標準
．零件清單
．試驗結果
4. IIa 類、IIb 類和 III 類器材的製造商應為每個器材準備一份定期安全更新報告（“PSUR”），並在與每個類別或器材組相關的情況下，總結後期分析的結果和結論。
5. 歐洲辦事處或授權代表的名稱和地址放在使用說明、外包裝或設備標籤上。
6. 除 I 類（非無菌、非測量）以外的所有設備，其 QMS 和技術文件或設計檔案皆必須由認證機構（歐洲當局認可的第三方審核醫療器材公司和產品）進行審核。

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).

【參考連結】

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

德國醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

答：

醫療器材的CE認證只有在歐盟網站公告的指定驗證機構(歐盟境內)，才具備醫療器材的CE符合性證書發證資格。
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
外國子公司進口醫療器材後，如果委託德國的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？

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：

需要於歐盟註冊並取得銷售當地的銷售憑證。每個經濟運營商（歐盟和非歐盟製造商、授權代表、系統/程序包生產商和進口商）都必須先在歐盟設立的網站： EUDAMED 註冊為參與者並提供所需信息。
當發生不良事件時，下列為負責人(通報及召回)：
1. 設備首次投放市場的負責人：製造商。
2. 若製造商在歐洲經濟區沒有註冊營業地，並且已指定授權代表，則由授權代表負責。
3. 如果醫療器材是由進口商輸入歐洲經濟區，沒有授權代表的情況下，則進口商是負責人。
4. 如果設備是在專業或商業框架內操作或使用，則醫療設備的運營商或用戶為負責人。
5. 向患者或其他非專業人士出售醫療器材供個人使用的分銷商、貿易商和授權的醫療或牙科人員。
6. 如果是以經銷商、進口商或其他自然人或法人的名稱、註冊商品名稱或註冊商標在市場上提供設備，除非分銷商或進口商與製造商達成協議，製造商在標籤上被識別為製造商並負責滿足本法規對製造商的要求，否則商標註冊者應當承擔製造商應盡的義務。

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.

【參考連結】

HLF-DE-85

各國醫療器材登記法規問答集

联系我们：
Email：fra4ww@evershinecpa.com
或
德國永輝BPO有限公司
Frankfurt time zone:
Dr. Chris Wu, 說德文中文和英文
或
China Time Zone:
聯絡人: 陳中成總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

附加資訊:
台北永輝協同網路服務股份有限公司
永輝啟佳聯合會計師事務所
地址:104臺北市中山區長春路378號6樓
捷運文湖線南京復興站,兄弟大飯店附近
所長 Principal Partner:
陳中成 Dale C.C. Chen;
會計師 in 台灣+中國+英國/企管碩士+企管博士/台灣專利師;
CPA in Taiwan+China+UK/ MBA+DBA/ Patent Attorney in Taiwan;
Mobile: +86-139-1048-6278 in China ;
Mobile:+886-933920199 in Taipei;
Wechat ID: evershiinecpa ;
Line ID:evershinecpa;
Skype:daleccchen ;
Linkedin Address: Dale Chen Linkedin

全球永輝服務據點參考資料:
永輝100%子公司：
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。

其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
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永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所.總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
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(版本:2022/03)

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