義大利醫療器材登記法規問題集

義大利主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。義大利與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
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或
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各國醫療器材登記法規問答集

時間：2022/09/18 drafted by Yvonne Chen

HLF-TW-10
請問義大利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 Italy? 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：
在義大利，衛生部 (MOH)是義大利醫療器材的監管機構。
歐盟將醫療器材分為兩類：
1.醫療器材：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、軟體、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。
2.體外診斷醫療器材：指單獨或組合形式的試劑、試劑產品、校準器、控制材料、試劑盒、儀器、設備、設備、軟體或系統的任何醫療器材，用於檢查來自人體的體外標本，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

風險等級由低至高：

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）

In Italy, the Ministry of Health (MOH) is the regulatory agency for medical devices in Italy.
The EU divides medical devices into two categories:

1. Medical device: refers to any instrument, device, appliance, software, implant, reagent, material or other item used for human beings for one or more specific medical purposes, either alone or in combination.
   ．Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
   ．Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability.
   ．Investigation, replacement or modification of anatomical structures, physiological or pathological processes.
   ．Applied to in vitro examinations of the human body, including organs, blood and tissues, and which cannot achieve their main intended role in or within the human body through pharmacological, immunological or metabolic means, but can assist their functions through these medical devices.
2. In vitro diagnostic medical equipment: refers to any medical equipment such as reagents, reagent products, calibrators, control materials, kits, instruments, equipment, equipment, software or systems, either alone or in combination, used to examine in vitro specimens from the human body. Includes blood and tissue.
   ． Relating to a physiological or pathological process or condition
   ． Related to congenital physical or mental disorders
   ． Relating to a physical condition or predisposition to disease
   ． Evaluation of safety and compatibility with potential recipients
   ． Predict treatment response
   ． Define or monitor treatments

Risk level from low to high:

1. Class I: non-sterile or not capable of measurement (low risk)
2. Class I: Sterile and measuring function (low/medium risk).
3. Class IIa (moderate risk)
4. Class IIb (medium/high risk)
5. Class III (high risk)

【參考連結】
https://reurl.cc/nLxE3D
https://www.salute.gov.it/portale/temi/p2_3_dispositivi.html

HLF-TW-20
外國公司要到義大利銷售醫療器材，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 Italy, 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：
無營業特許證。
No business license.

【參考連結】
https://www.salute.gov.it/portale/dispositiviMedici/homeDispositiviMedici.jsp

HLF-TW-25
假如需要辦理，請問義大利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：
無營業特許證。
No business license.

HLF-TW-30
外國公司要到義大利銷售醫療器材，可以指派義大利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 Italy, can it assign an Italy 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：
可以。
營業代理人需要是位於歐盟國家且是在歐盟境內營運的供應鏈一部分的合法公司，且必須善盡確保醫療器材符合歐盟CE標準、承擔分銷商的義務。

產品安全
1.當發生醫療器材產品安全疑慮時，衛生工作者有責任向衛生部通報安全事件、撰寫報告：
．事發地點
．來自發現事件的醫護人員的資料
．主管資料

2. 衛生部(MOH)依產品安全報告狀況公告FSN（現場安全通知）通知製造商退出市場或採取其他因應措施。

Yes.
The sales agent needs to be a legal company located in an EU country and part of the supply chain operating within the EU, and must ensure that the medical equipment complies with EU CE standards and assume the obligations of a distributor.

Product Safety

1. When concerns about the safety of medical equipment products occur, health workers have the responsibility to report the safety incident to the Ministry of Health and write a report:
   ． Place of incident
   ． Information from paramedics who discovered the incident
   ． Supervisor information
2. The Ministry of Health (MOH) issues an FSN (Field Safety Notice) based on the product safety report status, notifying the manufacturer to withdraw from the market or take other response measures.

【參考連結】
https://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

HLF-TW-35

HLF-TW-40
外國公司銷售到義大利醫療器材本身，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 Italy? 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：
需以義大利或歐盟成員國的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義大利衛生部(MOH)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
．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。
．品質等級證書：歐盟品質管理體系證書、歐盟品質保證證書、 歐盟生產品質保證證書。
4.臨床調查和性能研究(開發中)
5.警示和上市後監督(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。

標示
1.文件和標籤都必須用義大利語標示。

2. 所有包裝和包裝產品，無論是初級、二級或三級包裝，都需要貼上標籤才能投放義大利市場。
3. 醫療器材應附有 CE 標誌，並需在義大利衛生部資料庫中註冊。
   ．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黏貼，則應在包裝上貼 CE 標誌。
   ．CE 標誌應出現在任何使用說明和任何銷售包裝上。
   ．CE 標誌應由以下形式的首字母CE組成：

．如果CE標誌縮小或放大，應遵守上述刻度圖中給出的比例。
．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。
4.醫療器材依據其分類申請CE認證具備內容：
．Class I：自我宣告
．Class IIa /Class IIb /Class III: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。

Medical devices need to be registered on the EU website (EUDAMED) as a company in Italy 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, the product must be registered with the Italian Ministry of Health (MOH). ) registration.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ． Company name/Applicant name
   ． Contact number, email
   ． Country, city, street, postal code, etc.
2. UDI/Device Registration
   ． Manufacturer’s name, address
   ． Risk level
   ． Measurement function (yes/no)
   ． Reusable surgical equipment (yes/no)
   ． Active device (yes/no)
   ． Identify device model
   ． Technical documentation or certificate/declaration of conformity
   ． Equipment Quantity
   ． Unit of use
   ． Clinical scale
   ． Additional product description
   ． Single use (yes/no)
   ． Maximum number of reuses
   ． Whether sterilization is required
   ． Contains latex (yes/no)
   ． CMR/endocrine disruptors
   ． Severe warnings or contraindications
   ．Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
4. Clinical investigation and performance studies (under development)
5. Warning and post-market surveillance (under development)
6. Market supervision (under development)
7. The license issued by the EU is valid for 5 years.

Label

1. Documents and labels must be in Italian.
2. All packaging and packaging products, whether primary, secondary or tertiary packaging, need to be labeled before they can be placed on the Italian market.
3. Medical devices should bear the CE mark and be registered in the database of the Italian Ministry of Health.
   ．The CE mark should be clearly, clearly and indelibly affixed to the device or its sterile packaging. If adhesion is not possible or guaranteed due to the nature of the device, the CE marking should be affixed to the packaging.
   ．The CE marking should appear on any instructions for use and on any sales packaging.
   ．The CE mark shall consist of the initials CE in the following form:
   ．If the CE marking is reduced or enlarged, the proportions given in the scale diagram above should be observed.
   ．The various components of the CE mark should have essentially the same vertical dimensions, which should not be less than 5mm. For small devices, this minimum size may be waived.
4. Medical devices that apply for CE certification based on their classification must include:
   ．Class I: Self-declaration
   ．Class IIa /Class IIb /Class III: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain a CE certificate.

【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://reurl.cc/6QXYqZ
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129

HLF-TW-45

HLF-TW-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：
不行，需以義大利或歐盟成員國的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義大利衛生部(MOH)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
．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。
．品質等級證書：歐盟品質管理體系證書、歐盟品質保證證書、 歐盟生產品質保證證書。
4.臨床調查和性能研究(開發中)
5.警示和上市後監督(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。

標示
1.文件和標籤都必須用義大利語標示。

2. 所有包裝和包裝產品，無論是初級、二級或三級包裝，都需要貼上標籤才能投放義大利市場。
3. 醫療器材應附有 CE 標誌，並需在義大利衛生部資料庫中註冊。
   ．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黏貼，則應在包裝上貼 CE 標誌。
   ．CE 標誌應出現在任何使用說明和任何銷售包裝上。
   ．CE 標誌應由以下形式的首字母CE組成：

．如果CE標誌縮小或放大，應遵守上述刻度圖中給出的比例。
．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。
4.醫療器材依據其分類申請CE認證具備內容：
．Class I：自我宣告
．Class IIa /Class IIb /Class III: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。

No. Medical devices need to be registered on the EU website (EUDAMED) as a company in Italy 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, the product must be registered with the Italian Ministry of Health (MOH). ) registration.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ． Company name/Applicant name
   ． Contact number, email
   ． Country, city, street, postal code, etc.
2. UDI/Device Registration
   ． Manufacturer’s name, address
   ． Risk level
   ． Measurement function (yes/no)
   ． Reusable surgical equipment (yes/no)
   ． Active device (yes/no)
   ． Identify device model
   ． Technical documentation or certificate/declaration of conformity
   ． Equipment Quantity
   ． Unit of use
   ． Clinical scale
   ． Additional product description
   ． Single use (yes/no)
   ． Maximum number of reuses
   ． Whether sterilization is required
   ． Contains latex (yes/no)
   ． CMR/endocrine disruptors
   ． Severe warnings or contraindications
   ．Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
4. Clinical investigation and performance studies (under development)
5. Warning and post-market surveillance (under development)
6. Market supervision (under development)
7. The license issued by the EU is valid for 5 years.

Label

1. Documents and labels must be in Italian.
2. All packaging and packaging products, whether primary, secondary or tertiary packaging, need to be labeled before they can be placed on the Italian market.
3. Medical devices should bear the CE mark and be registered in the database of the Italian Ministry of Health.
   ．The CE mark should be clearly, clearly and indelibly affixed to the device or its sterile packaging. If adhesion is not possible or guaranteed due to the nature of the device, the CE marking should be affixed to the packaging.
   ．The CE marking should appear on any instructions for use and on any sales packaging.
   ．The CE mark shall consist of the initials CE in the following form:
   ．If the CE marking is reduced or enlarged, the proportions given in the scale diagram above should be observed.
   ．The various components of the CE mark should have essentially the same vertical dimensions, which should not be less than 5mm. For small devices, this minimum size may be waived.
4. Medical devices that apply for CE certification based on their classification must include:
   ．Class I: Self-declaration
   ．Class IIa /Class IIb /Class III: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain a CE certificate.

【參考連結】
https://reurl.cc/6QXYqZ
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129
https://ec.europa.eu/tools/eudamed/#/screen/home

HLF-TW-55

HLF-TW-60
經過核准登記的醫療器材，進口到義大利要檢附什麼文件？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 Italy? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關
1.海事、航空和邊境衛生辦公室 (USMAF)作為衛生部的外圍辦公室，監測從非歐盟國家進口的醫療器材活動，如果通過就會頒發進口衛生授權（NOS） 。
2.監測活動透過三個層級的驗證（文件、身分、材料）進行，以確定涉及健康利益的商品是否符合國家和社區法規制定的要求和規定。
3.監控活動以最終簽發進口准入令、健康許可 – NOS 結束，如果未能通過檢查，則簽發禁止進口令。
4.申請人：進口商或其法定代理人。
5.申請方式
．親自繳交
．傳真
．線上(https://nsis.sanita.it/ACCN/accessportalnsis/)
6.內容
．營運商須使用線上 NSIS-USMAF 程式提出進口衛生授權請求。
．在特定的Nulla Osta 請求選單中，填寫貨物進口的 NOS 請求。
．貨物隨附文件必須透過附加文件功能添加，除非有關該主題的現行立法要求提供原始文件。
．填妥後將請求摘要發送給負責該地區的 USMAF-SASN 地區部門。
．根據現行立法，NOS 放行申請隨附的文件會有所不同，具體取決於您打算進口的貨物或產品的類型。

無銷售通知。

Customs

1. The Office of Maritime, Aviation and Border Health (USMAF), as a peripheral office of the Ministry of Health, monitors the import of medical equipment from non-EU countries and issues an import health authorization (NOS) if passed.
2. Monitoring activities are carried out through three levels of verification (document, identity, material) to determine whether products involving health benefits comply with the requirements and regulations established by national and community regulations.
3. The monitoring activity ends with the final issuance of an import access order, health clearance – NOS and, if inspection fails, an import ban order.
4. Applicant: Importer or its legal agent.
5. How to apply
   ．Pay in person
   ．Fax
   ．Online (https://nsis.sanita.it/ACCN/accessportalnsis/)
6. Content
   ．Operators must use the online NSIS-USMAF program to submit import health authorization requests.
   ．In the specific Nulla Osta request form, fill in the NOS request for the import of goods.
   ．Documents accompanying the goods must be added via the Attach Documents function, unless current legislation on the subject requires the provision of original documents.
   ．Once completed, send a summary of the request to the USMAF-SASN regional unit responsible for that area.
   ．Under current legislation, the documentation accompanying an NOS release application will vary depending on the type of goods or products you intend to import.

No sales notice.

【參考連結】
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
https://www.salute.gov.it/portale/usmafsasn/dettaglioSchedaUsmafSasn.jsp?idMat=SMAF&idAmb=MER&idSrv=NOS&flag=P

HLF-TW-70
義大利醫療器材審核機構，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：
品質管理系統
1.製造商必須確保產品在器材的整個生命週期中都符合法規的規定。
2.品質管理系統所採用的所有要素、要求及規定均以品質手冊和書面策略和程序（例如品質計劃、計劃和報告）的形式有序地記錄下來。
3.製造商須繳交品質系統評估申請，經歐盟在生產現場進行審核後，授予歐盟品質管理系統證書。
4.IIa、IIb 類器材，須根據指導文件指示，以代表性的方式抽樣評估所選器材的技術文件。

技術文件
製造商必須繳交打算投放市場或投入設備的技術文件，並取得歐盟授予的歐盟技術文件評估證書，內容包含兩部分：
1.生產品質保證
．品質系統的應用必須保證產品符合法規的規定
．製造商為品質管理系統所採用的所有要素、要求及規定均以品質手冊和書面策略和程序（例如品質計劃和報告）的形式記錄。
2.產品驗證
．進行必要的檢查和測試，驗證設備是否符合法規的要求。
．每個設備均經過單獨檢查，並接受相關協調標準中定義的適當物理和實驗室測試或等效測試和評估，以驗證設備的符合性。

CE標誌規範

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、更新上市後監督系統，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，需要實施品質管理體系(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
   ．產品的標示，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。
   7.認證機構
   https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
   8.網頁
   https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

Quality management system

1. Manufacturers must ensure that products comply with regulations throughout the equipment’s entire life cycle.
2. All elements, requirements and regulations adopted by the quality management system are documented in an orderly manner in the form of quality manuals and written policies and procedures (such as quality plans, programs and reports).
3. The manufacturer must submit an application for quality system assessment, and after the EU conducts an audit at the production site, the EU quality management system certificate will be awarded.
4. For Class IIa and IIb equipment, the technical documents of the selected equipment must be evaluated in a representative manner according to the instructions of the guidance document.

Technical documents
Manufacturers must submit technical documents that they intend to put on the market or put into equipment, and obtain an EU technical document evaluation certificate issued by the EU, which contains two parts:

1. Production quality assurance
   ．The application of quality systems must ensure that products comply with regulatory requirements
   ．All elements, requirements and regulations adopted by the manufacturer for the quality management system are systematically and orderly documented in the form of quality manuals and written policies and procedures (e.g. quality plans and reports).
2. Product verification
   ．Perform necessary inspections and tests to verify equipment complies with regulatory requirements.
   ．Each device is individually inspected and submitted to appropriate physical and laboratory tests or equivalent tests and assessments as defined in the relevant harmonized standards to verify the device’s conformity.

CE marking specifications

1. Class I (non-sterile, non-measurement) needs to comply with the post-market surveillance (PMS) mechanism.
   ．Manufacturers should plan, establish, document, implement, maintain, and update a post-market surveillance system according to the device risk level and medical device classification to confirm the safety and efficacy of the product during its life cycle.
2. All equipment except Class I (non-sterile, non-measurement) need to implement a quality management system (QMS).
   ．Products can only be printed with the CE mark after obtaining certification documents. Manufacturers, agents or importers undergo inspections by internal product testing departments, or may invite external verification agencies to test products to implement quality management to ensure that mass-produced products meet the inspection-qualified samples.
3. Class I to Class IIb require a technical document, and Class II/AIMD equipment requires a design file.
   ．The name and address of the manufacturer or any authorized representative
   ．A brief description of the product
   ．Identification of the product, such as the product’s serial number
   ．Names and addresses of facilities involved in product design and manufacturing
   ．The name and address of any notified body involved in assessing the conformity of the product
   ．Statement on the conformity assessment procedures that have been followed
   ．EU Declaration of Conformity
   ．Labels and instructions for use
   ．Statement of relevant regulations that the product complies with
   ．Identify the technical standards to which compliance is claimed
   ．Parts List
   ．Test results
4. Manufacturers of Class IIa, IIb and III equipment should prepare a Periodic Safety Update Report (PSUR) for each equipment and, as relevant to each category or equipment group, summarize the results of subsequent analyzes and in conclusion.
5. The name and address of the European office or authorized representative is placed on the instructions for use, outer packaging or device label.
6. For all devices except Class I (non-sterile, non-measuring), their QMS and technical documentation or design files must be audited by a certification body (a third-party audit of medical device companies and products recognized by European authorities).
7. Certification
   https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
   8.URL
   https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

【參考連結】
https://reurl.cc/V4nlay
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口醫療器材後，如果委託義大利的經銷商銷售，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 Italy 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：

無營業特許證。

產品安全

1.當發生醫療器材產品安全疑慮時，衛生工作者有責任向衛生部通報安全事件、撰寫報告：

．事發地點

．來自發現事件的醫護人員的資料

．主管資料

2. 衛生部(MOH)依產品安全報告狀況公告FSN（現場安全通知）通知製造商退出市場或採取其他因應措施。

No business license.

Product Safety

1. When concerns about the safety of medical equipment products occur, health workers have the responsibility to report the safety incident to the Ministry of Health and write a report:

． Place of incident

． Information from paramedics who discovered the incident

． Supervisor information

2. The Ministry of Health (MOH) issues an FSN (Field Safety Notice) based on the product safety report status, notifying the manufacturer to withdraw from the market or take other response measures.

【參考連結】

https://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/

HLF-TW-85

※備註 (Eevershin內部參考)

網頁：https://nsis.sanita.it/ACCN/accessportalnsis/

此官方網頁是要有權限才能進去(沒有特別註明什麼權限)。

各國醫療器材登記法規問答集

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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 ;
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