法國醫療器材登記法規問題集
Email：par4ww@evershinecpa.com
或
法國永輝BPO有限公司
Paris time zone:
Manager Zhu, 法國永居卡居民 說法文中文和英文
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
HLF-FR-10
請問法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 France? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
歐盟將醫療器材分為兩大範疇：
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。
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。
醫療器材分為以下類別：
1. 非侵入式設備
2. 侵入性醫療器材
3. 有源醫療器材
4. 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）
在法國，衛生部轄下的國家藥品和保健產品安全局(ANSM) 負責監督和管理醫療器材。
The EU divides medical devices into two categories:
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.
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.
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)
In France, the National Agency for the Safety of Medicines and Health Products (ANSM) under the Ministry of Health oversees and regulates medical device.
【參考連結】
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
HLF-FR-20
外國公司要到法國銷售醫療器材，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 France, 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?
Evershine RD：
無須申請營業特許證。
No business license is required.
【參考連結】
HLF-FR-25
假如需要辦理，請問法國有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無須申請營業特許證。
HLF-FR-30
外國公司要到法國銷售醫療器材，可以指派法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 France, can it assign a France 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?
Evershine RD：
無營業特許證。
使用醫療器材後發生的嚴重不良反應，製造商和衛生專業人員必須立即向 ANSM 申報他們知道的所有事故或風險，製造商有上市後的警惕和監督報告義務。
當發現醫療器材不符合規定，經銷商必須立即通知製造商、授權代表和進口商，並有義務向主管當局(ANSM)報告發現嚴重風險的情況；進口商必須立即通知製造商和授權代表，並有義務向主管當局(ANSM)報告發現嚴重風險的情況。
當必須撤回/召回醫療產品時，由經銷商、製造商、授權代表、進口商以及主管當局合作，以確保採取必要的糾正措施。
網頁：https://signalement.social-sante.gouv.fr/psig_ihm_utilisateurs/index.html#/accueil
No business license.
Manufacturers and health professionals must immediately report to ANSM all accidents or risks of accidents that they are aware of in the event of serious adverse reactions following the use of medical devices.
Manufacturers have a post-marketing vigilance and surveillance reporting obligation.
When a medical device is found to be non-compliant, the distributor must immediately notify the manufacturer, the authorized representative and the importer, and is obliged to report the discovery of serious risks to the competent authority (ANSM); the importer must notify the manufacturer and the authorized representative immediately, and Obligation to report to the Competent Authority (ANSM) where serious risks are identified
When medical products must be withdrawn/recalled, the cooperation of distributors, manufacturers, authorised representatives, importers and competent authorities to ensure that necessary corrective actions are taken.
URL:https://signalement.social-sante.gouv.fr/psig_ihm_utilisateurs/index.html#/accueil
【參考連結】
HLF-FR-35
HLF-FR-40
外國公司銷售到法國醫療器材本身，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？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing medical devices sold to France? 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? Which languages are allowed? Website?
Evershine RD：
需要。須以法國或歐盟成員國之公司身分於歐盟網站(EUDAMED)註冊醫療器材，並於歐盟成員國中其中一個國家註冊產品，如未曾於歐盟成員國註冊產品則須向法國主管機關(ANSM)註冊。
歐盟(EUDAMED)註冊
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)
．可重複用的手術器械(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
．醫療器械命名法 (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)
7. 歐盟頒發的許可證有效期為5年。
法國(ANSM)醫療器材註冊
1. 所有 I 類醫療器械都必須在 ANSM 註冊，IIa、IIb 和 III 類器械必須在通知後才可以上市，所有醫療器械必須帶有 CE 標誌才能在法國銷售。
2.法國沒有電子程序，註冊和通知是通過提交紙本申請表並將文件提交給 ANSM 來完成。
3. 流程
．設備分類
．提交文件：ISO13485認證、文件分析、CE技術文件彙編等
．指定歐洲授權代表 (EAR)
．提交歐盟
．審查合格
．通知主管當局(ANSM)
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。
．製造商的地址必須是負責將其投放市場的人的註冊辦事處的地址，並且必須包括以下信息：街道/道路、數量/建築物/樓層、郵政編碼、城鎮、州/地區(如果適用)、國家
2. 在法國，醫療器械的標籤、隨附的傳單以及與其操作或使用有關的任何其他信息必須為法語版本。
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。
Medical devices must be registered on the EU website (EUDAMED) as a company in France or an EU member state, and the product must be registered in one of the EU member states. If the product has not been registered in an EU member state, it must be registered with the French competent authority (ANSM).
EU (EUDAMED) registration process
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 class
．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
．Use unit
．Clinical scale
．Additional Product Description
．Single use (yes/no)
．Maximum number of reuses
．Does it need to be sterilized?
．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 Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. Licenses issued by the European Union are valid for 5 years.
French (ANSM) medical device registration
1. All Class I medical devices must be registered with ANSM, Class IIa, IIb and III devices must be notified before they can be marketed, and all medical devices must bear the CE mark to be sold in France.
2. There is no electronic procedure in France, registration and notification are done by submitting a paper application form and submitting documents to ANSM.
3. Process
．Equipment classification
．Submitted documents: ISO13485 certification, document analysis, CE technical document compilation, etc.
．Appointed European Authorised Representative (EAR)
．Submit to the European Union
．Review qualified
．Notify the competent authority (ANSM)
Labeling and Instructions for Use:
1. Each product must be accompanied by all safety and performance information required for safe use, identification of the product, manufacturer or authorized representative.
．The manufacturer’s address must be the address of the registered office of the person responsible for placing it on the market and must include the following information: street/road, quantity/building/floor, zip code, town, state/region (if applicable), nation
2. In France, labels of medical devices, accompanying leaflets and any other information regarding their operation or use must be in French.
3. The label shall state that this product is a medical device.
4. The information provided by the manufacturer shall use symbols recognized in international format.
5. It is recommended to check the translation, the manufacturer will be held responsible for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
HLF-FR-45
HLF-FR-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？可允許的語文有哪些？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? Which languages are allowed?Website?
Evershine RD：
須以法國或歐盟成員國之公司身分於歐盟網站(EUDAMED)註冊醫療器材，並於歐盟成員國中其中一個國家註冊產品，如未曾於歐盟成員國註冊產品則須向法國主管機關(ANSM)註冊。
歐盟(EUDAMED)註冊流程
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)
．可重複用的手術器械(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
．醫療器械命名法 (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)
7. 歐盟頒發的許可證有效期為5年。
法國(ANSM)醫療器材註冊
1. 所有 I 類醫療器械都必須在 ANSM 註冊，IIa、IIb 和 III 類器械必須在通知後才可以上市，所有醫療器械必須帶有 CE 標誌才能在法國銷售。
2.法國沒有電子程序，註冊和通知是通過提交紙本申請表並將文件提交給 ANSM 來完成。
3. 流程
．設備分類
．提交文件：ISO13485認證、文件分析、CE技術文件彙編等
．指定歐洲授權代表 (EAR)
．提交歐盟
．審查合格
．通知主管當局(ANSM)
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。
．製造商的地址必須是負責將其投放市場的人的註冊辦事處的地址，並且必須包括以下信息：街道/道路、數量/建築物/樓層、郵政編碼、城鎮、州/地區(如果適用)、國家
2. 在法國，醫療器械的標籤、隨附的傳單以及與其操作或使用有關的任何其他信息必須為法語版本。
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。
Medical devices must be registered on the EU website (EUDAMED) as a company in France or an EU member state, and the product must be registered in one of the EU member states. If the product has not been registered in an EU member state, it must be registered with the French competent authority (ANSM).
EU (EUDAMED) registration process
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 class
．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
．Use unit
．Clinical scale
．Additional Product Description
．Single use (yes/no)
．Maximum number of reuses
．Does it need to be sterilized?
．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 Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. Licenses issued by the European Union are valid for 5 years.
French (ANSM) medical device registration
1. All Class I medical devices must be registered with ANSM, Class IIa, IIb and III devices must be notified before they can be marketed, and all medical devices must bear the CE mark to be sold in France.
2. There is no electronic procedure in France, registration and notification are done by submitting a paper application form and submitting documents to ANSM.
3. Process
．Equipment classification
．Submitted documents: ISO13485 certification, document analysis, CE technical document compilation, etc.
．Appointed European Authorised Representative (EAR)
．Submit to the European Union
．Review qualified
．Notify the competent authority (ANSM)
Labeling and Instructions for Use:
1. Each product must be accompanied by all safety and performance information required for safe use, identification of the product, manufacturer or authorized representative.
．The manufacturer’s address must be the address of the registered office of the person responsible for placing it on the market and must include the following information: street/road, quantity/building/floor, zip code, town, state/region (if applicable), nation
2. In France, labels of medical devices, accompanying leaflets and any other information regarding their operation or use must be in French.
3. The label shall state that this product is a medical device.
4. The information provided by the manufacturer shall use symbols recognized in international format.
5. It is recommended to check the translation, the manufacturer will be held responsible for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
HLF-FR-55
HLF-FR-60
經過核准登記的醫療器材，進口到法國要檢附什麼文件？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 France? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
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， 醫療器材產品進口、銷售時必須在產品上貼上CE合規標誌。
海關
1. 經濟經營者註冊和識別
於法國海關註冊取得EORI 編號
申請書內容：
．公司名稱/姓名(自然人)
．創建日期/生日
．地址、電話、電子郵件
．聯絡人
．SIRET號碼
．增值稅號碼
2. 於Delta網站完成電子報關，包含申報單（空運或海運艙單）、單一行政文件 (SAD)。
申報單內容
．運營商的名稱和EORI
．清關辦事處代碼
．報關處代碼
．包裹數量
．發件人的姓名和地址、收件人的姓名和地址
．商品的商業描述
．以千克為單位的總質量
．原產國代碼
．發票價值和貨幣
．進口聲明等
單一行政文件 (SAD)
．託運人
．收件人
．申報人
．出發時運輸工具、國家
．過境運輸工具、國家
．運輸方式
．商業編號
．付款方式
．目的地代碼
．交貨條款
．交易性質
．貨櫃編號、密封貼及編號
．商品代碼、重量
．稅務計算
．抵港日期
．辦事處
．聲明人等
3. 清關所需文件
．發票，應以法語書寫(或附有翻譯)
．計量(單位必須是公制)
．運輸文件（LTA/AWB、Maritim Connaissement/Bill of Lading、LTM、CMR 或 LVI）
．根據 CETA 協議的原產地聲明
．證明符合 EC 或法國標準的文件
Products bearing the CE certification label can be sold freely in all European Economic Community (EEC) member states without the need to undergo product testing in other countries. Goods manufactured outside the EU must have a full customs declaration in order to be freely sold within the EU market. Businesses and individuals wishing to trade are required to use the Economic Operator Registration and Identification Number (EORI) as their identification number in all customs procedures. The EORI number is an operator identification number valid throughout the EU, and the CE compliance mark must be affixed to the product when medical device is imported or sold.
Customs
1. Registration and identification of economic operators
Registered with French customs to obtain EORI number
Contents of application form:
． Company Name/Name (Natural Person)
． Creation Date/Birthday
． Address, phone, email
． Contact person
． SIRET number
． VAT number
2. Complete the electronic customs declaration on the Delta website, including the declaration form (air or sea manifest), single administrative document (SAD).
Contents of declaration form
． Operator’s name and EORI
． Customs Clearance Office Code
． Customs code
． Number of packages
． Sender’s name and address, recipient’s name and address
． Commercial description of the item
． Total mass in kilograms
． Country of origin code
． Invoice value and currency
． Import declaration, etc.
Single Administrative Document (SAD)
． Shipper
． Recipient
． Declarer
． Means of transport, country on departure
． Transit conveyance, country
． Shipping method
． Commercial number
． Payment method
． Destination code
． Terms of Delivery
． Transaction nature
． Container Numbers, Seals and Numbers
． Product code, weight
． Tax calculations
． Arrival date
． Office
． Declarant, etc.
3. Required documents for customs clearance
．Invoice, which should be written in French (or accompanied by a translation)
．Measurement (units must be in metric)
．Shipping Documentation (LTA/AWB, Maritim Connaissement/Bill of Lading, LTM, CMR or LVI)
．Declaration of Origin under CETA Agreement
．Documents proving conformity to EC or French standards
【參考連結】
https://www.douane.gouv.fr/professionnels
https://www.douane.gouv.fr/demarche/enregistrer-votre-entreprise-aupres-de-la-douane-numero-eori
https://archiveansm.integra.fr/
HLF-FR-70
法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?
Evershine RD：
在歐盟 (EU) 銷售醫療器械，產品皆須要取得 CE 標誌：CE 標誌應明顯、清晰、不可磨滅地貼在器械或其無菌包裝上。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。
醫療器械依據其分類申請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械指令，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 類器械的製造商應為每個器械準備一份定期安全更新報告（PSUR），並在與每個類別或器械組相關的情況下，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械公司和產品）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).
HLF-FR-75
醫療器械的CE認證只有在歐盟網站公告的指定驗證機構(歐盟境內)，才具備醫療器械的CE符合性證書發證資格。
HLF-FR-77
HLF-FR-80
外國子公司進口醫療器材後，如果委託法國的經銷商銷售，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 France 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?
Evershine RD：
無須申請營業特許證。
使用醫療器材後發生的嚴重不良反應，製造商和衛生專業人員必須立即向 ANSM 申報他們知道的所有事故或事故風險，製造商有上市後的警惕和監督報告義務。
當發現醫療器材不符合規定，經銷商必須立即通知製造商、授權代表和進口商，並有義務向主管當局(ANSM)報告發現嚴重風險的情況；進口商必須立即通知製造商和授權代表，並有義務向主管當局(ANSM)報告發現嚴重風險的情況。
當必須撤回/召回醫療產品時，由經銷商、製造商、授權代表、進口商以及主管當局合作，以確保採取必要的糾正措施。
No business license is required.
Manufacturers and health professionals must immediately report to ANSM all accidents or risks of accidents that they are aware of in the event of serious adverse reactions following the use of medical devices. Manufacturers have a post-marketing vigilance and surveillance reporting obligation.
When a medical device is found to be non-compliant, the distributor must immediately notify the manufacturer, the authorized representative and the importer, and is obliged to report the discovery of serious risks to the competent authority (ANSM); the importer must notify the manufacturer and the authorized representative immediately, and Obligation to report to the Competent Authority (ANSM) where serious risks are identified
When medical products must be withdrawn/recalled, the cooperation of distributors, manufacturers, authorised representatives, importers and competent authorities to ensure that necessary corrective actions are taken.
【參考連結】
HLF-FR-85
連繫人:
Email：par4ww@evershinecpa.com
或
法國永輝BPO有限公司
Paris time zone:
Manager Zhu, 法國永居卡居民 說法文中文和英文
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
永輝100%關係企業
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；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
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。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
更多城市更多服務 請點擊 網站導覽
