英代合同内容

2. The following procedures involved in the service of an UK Authorized Representative英国授权代表服务所涉及下列程序:a) Product Testing in order to obtain a te...

2. The following procedures involved in the service of an UK Authorized Representative英国授权代表服务所涉及下列程序:

a)       Product Testing in order to obtain a test report from 3rd party lab(whereas applicable) 产品检测,获得第三方检测报告(如适用);

b)       Documentation Review including test reports, manuals and package检测报告,包装及说明书等资料审核;

c)       Product Registration(whereas needed) 产品注册(适用时)

d)       Company Registration(whereas needed) 公司注册(适用时)

e)       Issue an Declaration of Conformity(DoC) 签发DoC证书;

f)        Sign the UK Authorized Representative Agreement签订英国授权代表协议。

g)       Carry out a randomly periodic compliance supervision进行定期审查。

 

4. Responsibilities and Obligations of The Parties各方的责任和义务

4.1Party A's obligations and rights甲方的义务和权利

4.1.1 Shall always comply with the relevant regulations / directives / harmonised standards of UK. Party A shall ensure that the products comply with the relevant regulations /directives/harmonized standards before being put on the market, and provide Party B with the product conformity certificate.始终遵守英国市场的相关法规/指令/协调标准及蓝皮书的有关规定,确保产品在投放市场前,符合相关法规/指令/协调标准的有关规定,并提供给乙方产品符合性证明文件。甲方“自我声明”产品在使用UKCA标记之前应提供符合要求的技术文档给乙方,若使用UKCA标记后3个月内仍没有提供符合要求的技术文档给乙方,则甲方承担由此引起的所有后果。

 

4.1.1.1 Party A must submit electronic documents in any format of PDF / word / JPG / AI / CDR / PSD. Written documents shall be submitted to Party B only when the UK authorities need to review them.甲方必需提交电子文件可以是PDF/WORD/JPG/AI/CDR/PSD等格式的任何一种。书面文件只有在英国当局需要审核时才提交乙方。

The requirements for the content of the submitted documents are as follows所提交文档内容的要求如下:

a)       Declaration of Conformity(DoC). 符合性声明

b)       Test reports supporting the DoC which issued by an ISO 17025 accreditated 3rd party lab. 具有ISO 17025资质的第三方实验室出具的支撑符合性声明的产品相关检测报告

c)       Certification issued by a Notified Body (where relevant). 公告机构出具的证书(适用时)

d)       Copy of photo the label, packaging and instructions for use (in all languages requested by the countries where the device is marketed). 标签、包装、说明书实物图副本(所有上市国家要求的语言的版本)

e)       Registration Letter (where relevant). 注册函(适用时)

f)        Post market surveillance process and data, vigilance reports and complaints, processes and data. 上市后监督过程和数据、警戒报告以及投诉、处理和数据

g)       Technical documentation relevant to market surveillance investigation being undertaken by competent authorities of UK government. 与英国监管机构的监督调查有关的技术文件

h)       Details of any distributors / suppliers putting the UKCA marked products on the market. 经销甲方UKCA标志产品的经销商/供方细节

i)        Incident reports and corrective actions taken. 事故报告及采取的纠正措施

4.1.1.2 Party A shall ensure the authenticity, validity and integrity of the documents provided. If the relevant documents is found invalid after verification, Party A shall provide corresponding documents in accordance with Party Bs revised requirements, and Party A shall bear all consequences arising therefrom甲方应确保所提供文件的真实性,有效性,完整性。若相关文件校验后出现真实性问题,甲方应按乙方修改要求提供相应文件,甲方承担由此而引起的所有后果。

4.1.1.3 Party A shall ensure that the documents provided can prove the uniqueness of the upstream and downstream relationship. For example, if the applicant of test report is a distributor, the test report shall also indicate the information of manufacturer.甲方应确保所提供文件资料能还原其真实的产品链路,例如,检测报告如申请方为经销商的,则检测报告须体现生产企业信息。

4.1.2 Party A shall always comply with the relevant regulations / directives / harmonized standards and blue books of UK markets, shall assist supervision and inspection of competent authorizes in UK and provide relevant materials and information for inquiry and investigation of relevant matters truthfully.应遵守英国市场的相关法规/指令/协调标准及蓝皮书的有关规定,协助英国监管机构的监督监查,对有关事项的询问和调查如实提供相关材料和信息。

4.1.3 From January 1, 2021, Party A shall ensure the effectiveness and continuity of the quality management system of the product manufacturer. If the production of the product is continuous, the product shall continue to meet the relevant requirements, and the UK representative information and UKCA certification mark shall be used correctly according to the regulations. Party A shall be able to provide any proof to production continuity, including but not limited to valid invoices, when required by Party B. 202111日起,应确保产品生产商持续有效运行相关质量管理体系,如果生产的产品是持续的,则产品应持续符合相关要求,应按规定正确使用英代信息及UKCA认证标志。甲方应能在乙方要求时,提供生产持续性证明,包括但不限于有效的发票。

4.1.4 Within the effective period of this Agreement, in case of any of the following situations, Party A shall report the relevant information to the following email address of Party B within 1 week after the following situation is happened: info@vish-tec.com. Party B shall take corresponding measures according to the information reported by Party A (including review of technical documents, review of DOC, and request the product to be tested by a random 3rd party lab, etc.)在本协议生效期间,甲方发生下列情况之一者,甲方需要在更新信息产生后一周之内以电子邮件的形式将相关信息发送到乙方以下电子邮箱:info@vish-tec.com,乙方视甲方通报的变更信息情况采取相应的措施(包括审查技术文件,审查DoC符合性声明,要求产品进行第三方检测等):

4.1.4.1 Major changes on product, including产品的重大变更,包括:

a)       Changes of production facilities / systems生产设施/体系的改变

b)       Productproductionthat need to be terminated for some reasonsfrom the quality system质量体系内某种原因需终止生产的产品

c)       Changes in manufacturing process工艺的改变

d)       Changes in main raw materials主要原材料的改变

4.1.4.2Serious product quality incident发生产品质量重大事故;

4.1.4.3 Major product complaints from customers顾客/相关方重大产品投诉;

4.1.4.4 The products sold are found not to meet the mandatory requirements by the competent authorities of UK

提供的产品被英国监管部门认定不符合法定要求;

4.1.5 Shall use the information of UK authorized representative correctly, In some cases, when the authorization of the UK Authorized Representative is suspended / revoked, the UK Authorized Representative shall stop using the product immediately, recall the product DoC to Party B and destroy all the product packages with the modified UK Authorized Representative information.正确使用英国授权代表信息,因故被暂停/撤销产品上加贴英国授权代表信息时,应停止使用产品英国授权代表,并向乙方交回产品DoC符合性申明和销毁全部有改英国授权代表信息的产品包装。

4.1.6 After receiving Party B's notice on the change of product conformity requirements, the product conformity assessment (including but not limited to product testing, product certification, product registration, revision of packaging and instruction manual) shall be carried out according to Party B's requirements within a given time, and accept a review of all updates from Party B. 在收到乙方关于产品符合性相关要求更改的通知后,在给定时间内根据乙方的要求实施产品符合性评价(包括但不限于产品检测,产品认证,产品注册更新,包装及说明书更新等),并接受由乙方文件审查方式对更改实施的结果的验证。

4.1.7 Before each product involved in this agreement is put into the UK markets, Party A must inform Party B, and shall provide Party B with the latest product label documents and UK distributor / supplier information, otherwise  Party A shall bear all consequences arising therefrom.本协议所涉及的每个产品在投放到英国市场之前,甲方必须通报给乙方,并且应向乙方提供最新的产品标签文件和英国经销商/供方的信息,若甲方没有通报给乙方以上信息,乙方将发出书面通知给甲方,要求甲方在乙方书面通知发出后1个月内向乙方提供最新的产品标签文件和英国经销商/供方的信息,若甲方逾期提供信息,甲方承担由此而引起的所有后果。

4.1.8 If any accident/near accident of products happens within boundary of UK, Party A shall help Party B to investigate the reason in time, and complete the initial report together with Party B. Party A shall present the investigation result and final report to Party B the Guidance of vigilance system. If the accident of the product happens out of UK, Party A shall notify Party B as soon as possible, and Part B should make decision whether to report to competent authority or not. If the above mentioned accident/near accident of products was known by Party A at first, Party A must send notification to the email of Party B as stipulated in Article 4.1.4 hereof in two calendar days and provide the complete report of the investigation, analysis and disposal result of the accident/near accident to Party B by E-mail or other effective means in writing within one week after relevant accident happened.

如果产品在英国境内发生事故或者准事故,甲方应及时配合乙方调查原因,并同乙方一起负责完成初始报告。甲方应在根据相应调查指南按相关产品法规/指令/标准规定的时间内向乙方报告调查结果和最终报告。如带UKCA标志的产品,其事故、准事故发生在英国境外,甲方应尽快告知乙方,并由乙方决定是否向主管当局报告。如果上述事故、准事故是通过甲方渠道先期获得的,甲方须立即在两个自然日内以电子邮件形式发送至上述第4.1.4条中的电子邮箱中;并需要对事故、准事故的调查、分析和处理结果的报告,用电子邮件或书面方式在相关事件产生后一周内通知乙方。

4.1.9 Party A shall be responsible for any business dispute related to their product problems, such as medical accidents or claims for compensation concerning quality that arise after sale. Parties B and C shall assist Party A to handle the dispute in accordance with the authorization of Party A. All the expenses occurred outside the china mainland during Party B and Party C's handling of the accident shall be borne by Party A after confirmation in writing by Party A. After Party A's written confirmation,. Party A should pay all of the cost of the traffic and other allowance for PART B’s employee or advisor in the china mainland for the need of considerable investigation, analysis and disposal of the accident. 甲方应对销售后发生的与其产品相关的责任事故或质量索赔等业务纠纷负责。乙方,丙方根据甲方的授权,协助甲方联络处理。乙方,丙方在事故处理中,需要支付的相关费用,须经甲方书面确认后由甲方承担。如果由于重大的调查、取证、质量投诉、事故和索赔的需要,乙方雇员或顾问在赴中国内地企业工作的食宿、交通等实际支出的费用,经甲方书面确认后由甲方承担。

4.1.10 Party A should keep the complete sales list of all of the products exporting to any area of UK (including the OEM products) by electrical documents in English at least 5 years, in order to be provided by Party B for the using to be transferred or inspected to the relevant competent authorities of UK Party A assures the accuracy and the validity of the data.

甲方出口英国市场所有产品的销售清单(包括OEM的销售清单),在产品停产后至少五年期间,必须用英文文字、电子文档形式保留完整无缺,以备乙方随时用于英国之官方的调用、检查。甲方要对提供的数据其准确性、真实性负责。

4.1.11 Party A must notice Party B the complaint record and the result of disposal on the accident of products immediately, and Party A should save, transfer, check-up any of the record according to the  article 4.1.10 on the above.甲方针对客户/用户的事故或者准事故的投诉、抱怨记录和处理结果,除了应该及时通知乙方以外,所有记录的保存、调用、检查,按照上述第“4.1.10”条条款办理。

4.1.12 Party A should appoint one person as the primacy linkman who connect with Party B and deal with the normal daily grind according to this Agreement. Information of both Parties’ linkman should be written in Last Page  The information delivered to the primacy linkman who connect with Party A by Party B shall be deemed as delivery to Party A and the instruction provided by the primacy linkman who connect with Party A shall be deemed as the instruction from Party A.甲方需指定一人,作为甲、乙双方的第一联络人,主要职责是与乙方共同协调、处理本协议条款规定范围内的日常工作。双方联络人的联络方式记录在本协议的尾页。乙方送达给甲方联络人的信息视作送达给甲方,甲方联络人给出的相关指示视作甲方给出的指示。

4.1.13 Party A shall fully realize the risk of selling its products to UK market without product conformity assessment as required, If it caused by Party A, such as delay, admittance or conceal of files submission, Party A should take the aftereffects such as warning, penalty or even the results that the UKCA certificate will be withdrawn, and the distribution of its products in UK market will be prohibited.甲方需要充分认识到本企业产品由于迟缓、延误、疏漏或者隐瞒而造成产品没有做符合性评价就投放在英国市场之必定带来的风险。如果由于甲方的原因,发生产品没有做符合性评价就进入英国市场的,甲方将承担罚款、警告、召回,甚至直至吊销UKCA产品证书和禁止产品进入英国的后果。

4.1.14 Party A will be fully responsible for the performance of its products and will hold Party BC harmless against any liability claim arising from the use of the products manufactured by Party A. 甲方为其产品承担全部质量责任,并将确保乙方,丙方不会因为甲方生产的产品在使用过程中产生的任何责任索赔而承担损失。

4.1.15 Each product involved in this agreement can only use information of Party C's as UKauthorized representative at the same time本协议所涉及的每个产品同一时间仅能使用丙方信息作为英代信息。

4.1.16 During the term of this Agreement, Party A shall voluntarily accept Party B's random quality supervision on the products involved in this Agreement, and, if necessary, carry out relevant procedures for conformity evaluation of products according to Party B's requirements本协议期间,甲方应自愿接受乙方对于本协议所涉及的产品的定期监督,需要时,根据乙方要求对产品进行符合性评价相关程序。

4.1.17 If this Agreement is not renewed until the expiration of this Agreement, Party A shall inform Party B of the inventory situation of each product involved in this agreement one month in advance, and immediately stop using Party C's representative information during manufacturing. 若本协议到协议期满未续签,甲方应提前一个月告知乙方本协议所涉及到每款产品英国地区的库存情况,并立即在产品出厂时停止使用丙方英代信息。

4.1.18 Party A shall not modify or forge the contents of this Agreement in any case,; in case of any alteration or forgery, this Agreement shall automatically become invalid在任何情况下,甲方不得篡改、伪造本协议,若出现篡改,伪造,则本协议自动失效。

4.1.19 If this Agreement is terminated, but the products involved in this Agreement still exist in the market, article 4.1.18 above shall be implemented若本协议失效,但本协议所涉及到产品还在流通市场存续的,执行上述4.1.8条款。

4.1.20 The UKCA marking alone cannot be used for goods placed on the Northern Ireland market, which require the CE marking or UK(NI) marking. UKCA标记不能单独用于放置在北爱尔兰市场上的货物,这些货物需要CE标记或UKNI)标记。

4.2 Obligations and rights of Party B乙方的义务和权利

4.2.1 Party B, as the sole agent of Party C in the People's Republic of China, shall exercise all rights and obligations of Party C required as the role of an UK Authorized Representative in accordance with the relevant laws and regulations of UK.乙方作为丙方在中华人民共和国唯一代理人,代为行使丙方根据英国相关法律法规对于英国授权代表的所有权利和义务。

4.2.2 Shall provide technical services to Party A objectively and fairly, shall abide by the laws and regulations of the country where Party B physically located and the contract. 遵守所在国的法律法规和本协议约定,客观、公正地为甲方提供技术服务;

4.2.3 Shall ensure the professional, accurate and efficient of the service which providing to Party A according to relevant product regulations / directives / harmonized standards, and ensure the response within 24 hours to the Party A's consultation.向甲方提供产品法规/指令/协调标准的咨询及技术服务,并确保在24小时内响应甲方的咨询,保障服务的专业,准确及高效;

4.2.4 When the product regulations / directives / harmonized standards of each product involved in this Agreement are revised, Party A shall be informed in time when the revision occur, and the impact on the conformity evaluation of each product involved in this Agreement shall be evaluated当本协议所涉及的每个产品的产品法规/指令/协调标准发生新增,变化时应在变化发生应及时通知甲方,并评估对本协议所涉及的每个产品的符合性评价的影响;

4.2.5 Shall timely inform Party A of the approval, suspension, restoration, cancellation and cancellation of notified bodies of the product involved in this agreement及时通知甲方本协议所涉及的每个产品的涉及的认证机构获准、暂停、恢复、注销、撤销产品注册资格状态;

4.2.6 Shall abide by the principle of confidentiality遵守保密原则;

4.2.7 If the production system and quality of Party A's products cannot be fully trusted, Party B has the right to require Party A to conduct temporary review, and, if necessary, relevant procedures for conformity assesment of products shall be carried out according to Party B's requirements如甲方的产品的生产体系、生产质量不能得到充分的信任,乙方有权要求甲方进行临时审查,需要时,根据乙方要求对产品进行符合性评价相关程序。

4.2.8 Party B shall carry out periodic supervision onquality status of each product involved in this agreement, but the period of each supervision shall not be less than 9 months乙方应对本协议所涉及的每个产品进行定期监督,但每单次监督周期不应短于9个月。

4.2.9 Periodic supervision includes but are not limited to product testing, inspection, factory audit, etc.定期监督程序包括但不限于产品检测,验货等。

4.2.10 If this Agreement is terminated, the service provided by Party B shall be terminated with this Agreement若本协议失效,乙方所提供的服务随本协议终止。

4.2.11 Party B shall reserve technical files of each category of party A's products with UKCA mark. The technical files shall be reserved for at least ten years after manufacturing of the last batch of products. Once competent authority needs the technical files (including new edition of the technical files which had already registered) of each category of part A’s products with UKCA mark. Party B should send them to competent authority within 10 working days乙方应保留本协议涉及每个产品的技术文档,该文档至少保存至最后一批产品出厂后十年。一旦英国主管当局需要获得 UKCA 标识产品的技术文件(含已备案的技术文件的新版本),乙方负责在 10个工作日内递交英国主管当局。

4.3 Obligations and rights of Party C丙方的义务和权利

4.3.1 Party C authorizes Party B to act as its sole agent in the people's Republic of China to exercise all rights and obligations of Party C to the UK Authorized Representative in accordance with the relevant laws and regulations of UK. 丙方授权乙方为其在在中华人民共和国唯一代理人,代为行使丙方根据英国相关法律法规对于英国授权代表的所有权利和义务。

4.3.2 Party C agrees that Party B shall be its sole partner in serving local sellers / enterprises in China. 丙方同意乙方为其在服务中国本地卖家/企业的唯一合作方。

4.3.3 Party C shall ensure protection of the data within this agreement comply with Article 5 of GDPR. 丙方应确保本协议内,所有相关数据符合GDPR 5条(Art. 5)。

4.3.4 Party C shall allow Party A to use its information and always act as UK Authorized Representative During the period of market circulation of the product involved in this Agreement. 丙方应同意甲方本协议下的产品使用丙方信息作为其欧代信息,并在本协议所涉及到每个产品进入流通市场,流通期间内,始终作为法规要求的英国授权代表联络窗口。

4.3.5 Party C shall undertake the responsibility of communicating with the competent authorities of the member states regarding each product involved in this Agreement, and handle the inquiries, reviews and investigations of the regulatory authorities of the member states promptly and effectively. 丙方应承担本协议所涉及每个产品,与英国监管机构沟通责任,及时有效处理英国监管机构的问询,审查及调查。

 

5. Risk liability风险责任的承担

5. 1If each product involved in this Agreement needs to be put on the platform, Party A shall ensure that they meet the requirements of the rules of the platform, and shall bear the risk that the listing is removed if it fails to comply with the rules of the platform. 本协议所涉及的每个产品,需在平台上架的,甲方应确保符合平台的规则要求,承担不能符合平台的规则要求而被链接下架的风险。

5. 2 If an certification action of a Notified Body is involved in the conformity assessment procedure of product involved in this Agreement, Party A shall bear the risk that the qualification of the Notified Body is revoked and suspended, resulting in the invalidation of the certificate.本协议所涉及的每个产品,如涉及到需要认证机构发证的,甲方承担认证机构资质被撤销,暂停而导致证书失效及英国授权代表服务撤销的风险。

 

6. Effectiveness of the agreement and other matters协议的生效及其他事宜                                                                                 

6.1This Agreement shall come into force as of the date of signature and seal by Parties本协议各方签字盖章之日起生效。

6.2All parties must conscientiously implement the Agreement, which shall not be cancelled during the effective period of the agreement. 各方必须认真履行协议,协议生效期间内,不得取消。

6.3For matters not covered in this agreement, the parties agree to reach an agreement through the supplementary agreement, which has the same effect as the agreement; if the dispute leads to litigation, it shall be decided by the local court of Party B本协议未尽事宜,各方同意通过补充协议达成一致,补充协议与协议具有同等效力;协商不一致导致诉讼的,由乙方所属地方法院裁决。

6.4 This Agreement and all its appendixes are written in both Chinese and English. If the interpretation of the Chinese version and the English version differs, Chinese shall prevail. 协议及所有附件以中英文两种语言撰写,如中英文解释发生差异,以中文为准。

6.5 This agreement consists of the main text and appendices and is made in triplicate, one for each party本协议由正文和附录组成,一式叁份,各方各执壹份。

 


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