法国医疗器材登记法规问题集

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HLF-FR-40
外国公司销售到法国医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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。须以法国或欧盟成员国之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法国主管机关(ANSM)註册。

欧盟(EUDAMED)註册

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)

．可重複用的手术器械(是/否)

．有源设备(是/否)

．识别设备型号

．技术文件或合格证书/声明

．设备数量

．使用单位

．临床规模

．附加产品说明

．一次性使用(是/否)

．最大重複使用次数

．是否需要灭菌

．含乳胶(是/否)

．CMR/内分泌干扰物

．严重警告或禁忌症

．医疗器械命名法 (CND) 代码等

3.证书和公告机构

．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。

．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、 欧盟生产质量保证证书。

4.临床调查和性能研究(开发中)

5.警惕和上市后监督(开发中)

6.市场监督(开发中)

7. 欧盟颁发的许可证有效期为5年。

法国(ANSM)医疗器材註册

1. 所有 I 类医疗器械都必须在 ANSM 註册，IIa、IIb 和 III 类器械必须在通知后才可以上市，所有医疗器械必须带有 CE 标誌才能在法国销售。

2.法国没有电子程序，註册和通知是通过提交纸本申请表并将文件提交给 ANSM 来完成。

3. 流程

．设备分类

．提交文件：ISO13485认证、文件分析、CE技术文件彙编等

．指定欧洲授权代表 (EAR)

．提交欧盟

．审查合格

．通知主管当局(ANSM)

标籤和使用说明：

1. 每个产品都必须附有安全使用、识别产品、製造商或授权代表所需的所有安全和性能信息。

．製造商的地址必须是负责将其投放市场的人的註册办事处的地址，并且必须包括以下信息：街道/道路、数量/建筑物/楼层、邮政编码、城镇、州/地区(如果适用)、国家

2. 在法国，医疗器械的标籤、随附的传单以及与其操作或使用有关的任何其他信息必须为法语版本。

3. 标籤应说明该产品是医疗装置。

4. 製造商提供的信息须採用国际格式公认的符号。

5. 建议检查翻译，由于不正确或误导性翻译而对患者或其他人造成人身伤害，製造商需要承担责任。

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.

【参考连结】

https://ec.europa.eu/tools/eudamed/#/screen/home

https://archiveansm.integra.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/COVID-19-Commercialisation-des-DM-et-DMDIV/(offset)/0

HLF-FR-45

HLF-FR-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？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：

须以法国或欧盟成员国之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法国主管机关(ANSM)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)

．可重複用的手术器械(是/否)

．有源设备(是/否)

．识别设备型号

．技术文件或合格证书/声明

．设备数量

．使用单位

．临床规模

．附加产品说明

．一次性使用(是/否)

．最大重複使用次数

．是否需要灭菌

．含乳胶(是/否)

．CMR/内分泌干扰物

．严重警告或禁忌症

．医疗器械命名法 (CND) 代码等

3.证书和公告机构

．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。

．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、 欧盟生产质量保证证书。

4.临床调查和性能研究(开发中)

5.警惕和上市后监督(开发中)

6.市场监督(开发中)

7. 欧盟颁发的许可证有效期为5年。

法国(ANSM)医疗器材註册

1. 所有 I 类医疗器械都必须在 ANSM 註册，IIa、IIb 和 III 类器械必须在通知后才可以上市，所有医疗器械必须带有 CE 标誌才能在法国销售。

2.法国没有电子程序，註册和通知是通过提交纸本申请表并将文件提交给 ANSM 来完成。

3. 流程

．设备分类

．提交文件：ISO13485认证、文件分析、CE技术文件彙编等

．指定欧洲授权代表 (EAR)

．提交欧盟

．审查合格

．通知主管当局(ANSM)

标籤和使用说明：

1. 每个产品都必须附有安全使用、识别产品、製造商或授权代表所需的所有安全和性能信息。

．製造商的地址必须是负责将其投放市场的人的註册办事处的地址，并且必须包括以下信息：街道/道路、数量/建筑物/楼层、邮政编码、城镇、州/地区(如果适用)、国家

2. 在法国，医疗器械的标籤、随附的传单以及与其操作或使用有关的任何其他信息必须为法语版本。

3. 标籤应说明该产品是医疗装置。

4. 製造商提供的信息须採用国际格式公认的符号。

5. 建议检查翻译，由于不正确或误导性翻译而对患者或其他人造成人身伤害，製造商需要承担责任。

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.

【参考连结】

https://ec.europa.eu/tools/eudamed/#/screen/home

https://archiveansm.integra.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/COVID-19-Commercialisation-des-DM-et-DMDIV/(offset)/0

https://archiveansm.integra.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DM-et-DMIA-Principaux-textes-interpretatifs/(offset)/8

HLF-FR-55

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

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

Evershine RD：

贴有 CE 认证标籤的产品可在所有欧洲经济共同体 (简称 EEC) 会员国国内自由贩售，不需经过其他国家产品检测。
欧盟以外地区製造的货品必须具备完整的海关申报书，才能在欧盟市场内自由贩卖。
希望进行贸易的企业和个人在必须在所有海关程序中使用经济经营者註册和识别号 (EORI)作为识别号。EORI 编号是在整个欧盟范围内有效的运营商识别号， 医疗器材产品进口、销售时必须在产品上贴上CE合规标誌。

海关

1. 经济经营者註册和识别

于法国海关註册取得EORI 编号

申请书内容：

．公司名称/姓名(自然人)

．创建日期/生日

．地址、电话、电子邮件

．联络人

．SIRET号码

．增值税号码

2. 于Delta网站完成电子报关，包含申报单（空运或海运舱单）、单一行政文件 (SAD)。

申报单内容

．运营商的名称和EORI

．清关办事处代码

．报关处代码

．包裹数量

．发件人的姓名和地址、收件人的姓名和地址

．商品的商业描述

．以千克为单位的总质量

．原产国代码

．发票价值和货币

．进口声明等

单一行政文件 (SAD)

．託运人

．收件人

．申报人

．出发时运输工具、国家

．过境运输工具、国家

．运输方式

．商业编号

．付款方式

．目的地代码

．交货条款

．交易性质

．货柜编号、密封贴及编号

．商品代码、重量

．税务计算

．抵港日期

．办事处

．声明人等

3. 清关所需文件

．发票，应以法语书写(或附有翻译)

．计量(单位必须是公制)

．运输文件（LTA/AWB、Maritim Connaissement/Bill of Lading、LTM、CMR 或 LVI）

．根据 CETA 协议的原产地声明

．证明符合 EC 或法国标准的文件

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

【参考连结】

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
法国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

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

Evershine RD：

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

1. CE 标誌应由以下形式的首字母“CE”组成：

2. 如果CE标誌缩小或放大，应遵守上述刻度图中给出的比例。

3. CE标誌的各个组成部分应具有基本相同的垂直尺寸，不得小于5mm。对于小型设备，可以免除此最小尺寸。

医疗器械依据其分类申请CE认证具备内容：

1. ClassI：自我宣告即可

2. ClassIIa/ClassIIb/ClassIII:须符合相对应之医疗器械指令，通过认证机构评鑑(Notified Body Conformity Assessment Procedure)，取得CE证书。

注意事项：

1.  I 类（非无菌、非测量）需要符合上市后监控(PMS) 机制。

．製造商应依器材风险等级和医材分类，规划、建立、文件化、施行、维护与持续更新上市后监督系统，以确认产品生命週期间的安全与功效。

2. 除 I 类（非无菌、非测量）以外的所有设备，需要实施质量管理体系(QMS) 。

．产品在取得认证文件后才可印上CE标誌。製造商、代理或进口商经过内部设立的产品检测部门检测，或会邀请外部的验证机构测试产品实施品质管理，确保量产产品符合检验合格之样品。

3. I 类到 IIb 类，需要一份技术文件，II 类/AIMD 设备为设计档案。

．製造商或任何授权代表的姓名和地址

．产品的简要说明

．产品的标识，例如产品的序列号

．产品设计和製造所涉及的设施的名称和地址

．参与评估产品符合性的任何公告机构的名称和地址

．已遵循的合格评定程序的声明

．欧盟符合性声明

．标籤和使用说明

．产品符合的相关法规的声明

．识别声称符合的技术标准

．零件清单

．试验结果

4. IIa 类、IIb 类和 III 类器械的製造商应为每个器械准备一份定期安全更新报告（PSUR），并在与每个类别或器械组相关的情况下，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械公司和产品）进行审核。

The sale of medical devices in the European Union (EU) requires CE marking of products: the CE marking should be conspicuously, clearly and indelibly affixed to the device or its sterile packaging. If, due to the nature of the equipment, such affixing is not possible or warranted, the CE marking shall be affixed to the packaging. The CE marking should also appear on any instructions for use and on any sales packaging.

1. The CE marking shall consist of the initials “CE” in the following form:

2. If the CE marking is reduced or enlarged, the proportions given in the scale diagram above shall be observed.

3. The various components of the CE mark shall have substantially the same vertical dimension and shall not be less than 5mm. For small devices, this minimum size can be waived.

Medical devices applying for CE certification according to their classification have the following contents:

1. Class I: self-declaration is enough

2. ClassIIa/ClassIIb/ClassIII: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain the CE certificate.

Precautions:

1. Category I (non-sterile, non-measured) requires compliance with post-market surveillance (PMS) mechanisms.

．Manufacturers should plan, establish, document, implement, maintain and continuously update post-market surveillance systems based on device risk levels and medical material classifications to confirm product safety and efficacy during the product life cycle.

2. All equipment other than Class I (non-sterile, non-measuring) requires the implementation of a quality management system (QMS).

．Products can only be printed with the CE mark after obtaining the certification documents. Manufacturers, agents or importers have been tested by the internal product testing department, or they may invite external verification agencies to test the products to implement quality management to ensure that the mass-produced products meet the samples that have passed the inspection.

3. For Class I to Class IIb, a technical file is required, and Class II/AIMD equipment is a design file.

．The name and address of the manufacturer or any authorized representative

． Brief description of the product

．Identification of the product, such as the product’s serial number

．The name and address of the facility involved in the design and manufacture of the product

．Name and address of any notified body involved in assessing product conformity

． Statement of conformity assessment procedures followed

．EU Declaration of Conformity

．Labels and Instructions for Use

．Statement of relevant regulations to which the product complies

．Identify technical standards claimed to be compliant

．Parts List

．test results

4. Manufacturers of Class IIa, IIb and III devices shall prepare a Periodic Safety Update Report (“PSUR”) for each device and, where relevant to each class or device group, summarizing the results and conclusions.

5. The name and address of the European office or authorized representative are placed on the instructions for use, on the outer packaging or on the device label.

6. For all devices other than Class I (non-sterile, non-measurement), their QMS and technical or design files must be reviewed by a certification body (a third-party audit of medical device companies and products recognized by European authorities).

HLF-FR-75

医疗器械的CE认证只有在欧盟网站公告的指定验证机构(欧盟境内)，才具备医疗器械的CE符合性证书发证资格。

HLF-FR-77

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

After a foreign subsidiary imports medical devices and entrusts a distributor in 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：

无须申请营业特许证。

使用医疗器材后发生的严重不良反应，製造商和卫生专业人员必须立即向 ANSM 申报他们知道的所有事故或事故风险，製造商有上市后的警惕和监督报告义务。

当发现医疗器材不符合规定，经销商必须立即通知製造商、授权代表和进口商，并有义务向主管当局(ANSM)报告发现严重风险的情况；进口商必须立即通知製造商和授权代表，并有义务向主管当局(ANSM)报告发现严重风险的情况。

当必须撤回/召回医疗产品时，由经销商、製造商、授权代表、进口商以及主管当局合作，以确保採取必要的纠正措施。

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.

【参考连结】

https://solidarites-sante.gouv.fr/soins-et-maladies/autres-produits-de-sante/article/les-dispositifs-medicaux-implants-protheses

https://ansm.sante.fr/

HLF-FR-85

各国医疗器材登记法规问答集

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