义大利医疗器材登记法规问题集

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各国医疗器材登记法规问答集

时间：2022/09/18 drafted by Yvonne Chen

HLF-TW-10
请问义大利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 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：
在义大利，卫生部 (MOH)是义大利医疗器材的监管机构。
欧盟将医疗器材分为两类：
1.医疗器材：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、软体、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。
2.体外诊断医疗器材：指单独或组合形式的试剂、试剂产品、校准器、控制材料、试剂盒、仪器、设备、设备、软体或系统的任何医疗器材，用于检查来自人体的体外标本，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

风险等级由低至高：

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）

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)

【参考连结】
https://reurl.cc/nLxE3D
https://www.salute.gov.it/portale/temi/p2_3_dispositivi.html

HLF-TW-20
外国公司要到义大利销售医疗器材，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，其必要条件是什么？所需文件及申请程序为何？网页？

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：
无营业特许证。
No business license.

【参考连结】
https://www.salute.gov.it/portale/dispositiviMedici/homeDispositiviMedici.jsp

HLF-TW-25
假如需要办理，请问义大利有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
无营业特许证。
No business license.

HLF-TW-30
外国公司要到义大利销售医疗器材，可以指派义大利公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什么？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 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。
营业代理人需要是位于欧盟国家且是在欧盟境内营运的供应链一部分的合法公司，且必须善尽确保医疗器材符合欧盟CE标准、承担分销商的义务。

产品安全
1.当发生医疗器材产品安全疑虑时，卫生工作者有责任向卫生部通报安全事件、撰写报告：
．事发地点
．来自发现事件的医护人员的资料
．主管资料

2. 卫生部(MOH)依产品安全报告状况公告FSN（现场安全通知）通知製造商退出市场或採取其他因应措施。

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.

【参考连结】
https://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

HLF-TW-35

HLF-TW-40
外国公司销售到义大利医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什么文件？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？可允许的语文有哪些？网页？

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：
需以义大利或欧盟成员国的公司身分于欧盟网站(EUDAMED)註册医疗器材，并于欧盟成员国中其中一个国家註册产品，如未曾于欧盟成员国註册产品则须向义大利卫生部(MOH)註册。

欧盟(EUDAMED)註册流程
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
．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。
．品质等级证书：欧盟品质管理体系证书、欧盟品质保证证书、 欧盟生产品质保证证书。
4.临床调查和性能研究(开发中)
5.警示和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。

标示
1.文件和标籤都必须用义大利语标示。

2. 所有包装和包装产品，无论是初级、二级或三级包装，都需要贴上标籤才能投放义大利市场。
3. 医疗器材应附有 CE 标誌，并需在义大利卫生部资料库中註册。
   ．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黏贴，则应在包装上贴 CE 标誌。
   ．CE 标誌应出现在任何使用说明和任何销售包装上。
   ．CE 标誌应由以下形式的首字母CE组成：

．如果CE标誌缩小或放大，应遵守上述刻度图中给出的比例。
．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。
4.医疗器材依据其分类申请CE认证具备内容：
．Class I：自我宣告
．Class IIa /Class IIb /Class III: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。

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.

【参考连结】
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？需要什么文件？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？可允许的语文有哪些？？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? Which languages are allowed?? Website?
Evershine RD：
不行，需以义大利或欧盟成员国的公司身分于欧盟网站(EUDAMED)註册医疗器材，并于欧盟成员国中其中一个国家註册产品，如未曾于欧盟成员国註册产品则须向义大利卫生部(MOH)註册。

欧盟(EUDAMED)註册流程
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
．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。
．品质等级证书：欧盟品质管理体系证书、欧盟品质保证证书、 欧盟生产品质保证证书。
4.临床调查和性能研究(开发中)
5.警示和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。

标示
1.文件和标籤都必须用义大利语标示。

2. 所有包装和包装产品，无论是初级、二级或三级包装，都需要贴上标籤才能投放义大利市场。
3. 医疗器材应附有 CE 标誌，并需在义大利卫生部资料库中註册。
   ．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黏贴，则应在包装上贴 CE 标誌。
   ．CE 标誌应出现在任何使用说明和任何销售包装上。
   ．CE 标誌应由以下形式的首字母CE组成：

．如果CE标誌缩小或放大，应遵守上述刻度图中给出的比例。
．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。
4.医疗器材依据其分类申请CE认证具备内容：
．Class I：自我宣告
．Class IIa /Class IIb /Class III: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。

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.

【参考连结】
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
经过核准登记的医疗器材，进口到义大利要检附什么文件？经过什么手续？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 Italy? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海关
1.海事、航空和边境卫生办公室 (USMAF)作为卫生部的外围办公室，监测从非欧盟国家进口的医疗器材活动，如果通过就会颁发进口卫生授权（NOS） 。
2.监测活动透过三个层级的验证（文件、身分、材料）进行，以确定涉及健康利益的商品是否符合国家和社区法规制定的要求和规定。
3.监控活动以最终签发进口准入令、健康许可 – NOS 结束，如果未能通过检查，则签发禁止进口令。
4.申请人：进口商或其法定代理人。
5.申请方式
．亲自缴交
．传真
．线上(https://nsis.sanita.it/ACCN/accessportalnsis/)
6.内容
．营运商须使用线上 NSIS-USMAF 程式提出进口卫生授权请求。
．在特定的Nulla Osta 请求选单中，填写货物进口的 NOS 请求。
．货物随附文件必须透过附加文件功能添加，除非有关该主题的现行立法要求提供原始文件。
．填妥后将请求摘要发送给负责该地区的 USMAF-SASN 地区部门。
．根据现行立法，NOS 放行申请随附的文件会有所不同，具体取决于您打算进口的货物或产品的类型。

无销售通知。

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.

【参考连结】
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
义大利医疗器材审核机构，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?
Evershine RD：
品质管理系统
1.製造商必须确保产品在器材的整个生命週期中都符合法规的规定。
2.品质管理系统所採用的所有要素、要求及规定均以品质手册和书面策略和程序（例如品质计划、计划和报告）的形式有序地记录下来。
3.製造商须缴交品质系统评估申请，经欧盟在生产现场进行审核后，授予欧盟品质管理系统证书。
4.IIa、IIb 类器材，须根据指导文件指示，以代表性的方式抽样评估所选器材的技术文件。

技术文件
製造商必须缴交打算投放市场或投入设备的技术文件，并取得欧盟授予的欧盟技术文件评估证书，内容包含两部分：
1.生产品质保证
．品质系统的应用必须保证产品符合法规的规定
．製造商为品质管理系统所採用的所有要素、要求及规定均以品质手册和书面策略和程序（例如品质计划和报告）的形式记录。
2.产品验证
．进行必要的检查和测试，验证设备是否符合法规的要求。
．每个设备均经过单独检查，并接受相关协调标准中定义的适当物理和实验室测试或等效测试和评估，以验证设备的符合性。

CE标誌规范

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、更新上市后监督系统，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，需要实施品质管理体系(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
   ．产品的标示，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。
   7.认证机构
   https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
   8.网页
   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

【参考连结】
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
外国子公司进口医疗器材后，如果委託义大利的经销商销售，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 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：

无营业特许证。

产品安全

1.当发生医疗器材产品安全疑虑时，卫生工作者有责任向卫生部通报安全事件、撰写报告：

．事发地点

．来自发现事件的医护人员的资料

．主管资料

2. 卫生部(MOH)依产品安全报告状况公告FSN（现场安全通知）通知製造商退出市场或採取其他因应措施。

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.

【参考连结】

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

HLF-TW-85

※备註 (Eevershin内部参考)

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

此官方网页是要有权限才能进去(没有特别註明什么权限)。

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