1、医疗器械进口框架协议英文版Framework Agreement of Importing the Medical DevicesManufacturer:.Add:Tel: Fax:E-mail:http/:Wechat:Importer:Add:Tel: Fax:F-mail:http/:Wechat:(Hereinafterjointly referred to as the “Parties”)In view of the fact that the importer will purchase the products produced by the manufacturer and
2、 sell the products to EU countries,andEU countries have increased thecontrol and supervisionof medical devices,inorder to clarify that the respective responsibilities of both parties need to be performed,thisAgreementis madeand entered intoby and between theManufacturerand the Importer, according to
3、 the terms and conditions stated below:DefinitionsProduct(s): These aremedical devices. They are sold exclusively by the legal manufacturer to theimporter. The Products are listed in Appendix 1.Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material or other
4、article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or c
5、ompensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means ofin vitroexamination of specimens derived from the human body, including organ, blood and tissue donations,and w
6、hich does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.The following products shall also be deemed to be medical devices: devices for the control or support of concepti
7、on; products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in MDR Article 1(4) and of those referred to in the first paragraph of this point.Manufacturer: A natural or legal person who manufactures or fully refurbishes a device or has a device design
8、ed, manufactured or fully refurbished, and markets that device under its name or trade mark;Importer: Any natural or legal person established within the Union that places a device from a third country on the Union market.Distributor: Any natural or legal person in the supply chain, other than the ma
9、nufacturer or the importer that makes a device available on the market, up until the point of putting into service.Serious incident: Any incident that directly or indirectly resulted, may have resulted or maybe likely to result in:+The death of a patient, user or any other person,+A serious deterior
10、ation, temporary or permanent, in the state of health of a patient, user or any other person,+A serious threat to public health.Non-Serious Incident:Any malfunction or alteration in the characteristics and performance ofa device made available on the market, including an operating error due to ergon
11、omicfeatures as well as any defect in the information provided by the manufacturer and anyundesirable side effects.Regulations (non-exhaustive)vDirective 93/42/EC modified by Directive 2007/47/EC (only for products benefiting from the Legacy device)vEN ISO 13485vRegulation EU 2017/745 of 5/4/2017 (e
12、ffective May 2021)1) - Purpose of theAgreement- SubjectThe purpose of this Agreement is to define the regulation responsibilities of both parties during the Products import by the Importer from the Manufacturer. The Products are defined in Appendix 1.The provisions of this Agreement shall apply to a
13、ll orders for Products placed by theimporter.2) Liability Responsibility of the Manufacturer2.1) Compliance with national and European legal and regulatory provisionsand all other provisions applicable to the ProductsThe manufacturer undertakes to strictly comply with all legal, regulatory, and Euro
14、peanand possibly international obligations in force applicable to the Products, and all otherapplicable provisions.2.2)The manufacturer is obliged to comply with the requirementsDirective 93/42/EC modified by Directive 2007/47/EC (only for products benefiting from the Legacy device) and theEuropean
15、regulation 2017/745, in particular with :Its registration in the EUDAMED database;Affixing a UDI code on its devices;Maintenance of a post-marketing surveillance system, with notification of incidents tothe competent authorities via EUDAMED database;The realization of necessary investigations follow
16、ing the notification of a seriousincident with the realization of a report transmitted to the competent authorities viaEUDAMEDdatabase;(non-exhaustive list - refer to regulation 2017/745 Article 10).2.3)The manufacturershall, in a manner that is proportionate to the risk class, type of device and th
17、e size of the enterprises, have measures in place to provide sufficient financial coverage in respect of their potential liabilityof the possible defective devices.2.4)The manufacturershall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant
18、certificate, including any amendments and supplements available for the competent authorities for a period of at least10 yearsafter the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least15 yearsafter
19、 the last device has been placed on the market.2.5)The manufacturer shallensure to satisfy the request by the EU competent authorities, forwarded bythe importer, for example samples or access to devices, providingwith all the information and documentation necessary to demonstrate the conformity of t
20、he devices.2.6)The manufacturershall have a system for recording and reporting of incidents and field safety corrective actions.If any accidentornear accident ofdevices (including any serious adverse event during clinical investigation in premarket stage)happensin the territoryof EU, EEA and Switzer
21、land, Turkey,the manufacturer shall investigate the reason in time, and complete the initial report. The manufacturer shall present the investigation result and final report according toEU2017/745(MDRdevices),and the Guidance ofVigilanceSystem.2.7)The manufacturer should keep the complete sales list
22、 of all of thedevices exporting to EU, EEA and Switzerland，Turkey (including the OEMdevices) by electrical documentationin English at least10years after the last device has been placed on the market(15 yearsIn the case of implantable devices), in order to be provided for inspectionbythe relevant com
23、petent authorities of EU, EEA and Switzerland, Turkey.The manufactureris responsible forthe accuracy and the validity of the data.2.8)The manufacturer must keep the complete complain recordsand the resultsof disposalson the accidents or near accidentsof products, and the manufacture should save, tra
24、nsfer, check-up any of the recordsaccording to therequirements of abovearticle 2.7ofthe manufacture.2.9)If the manufacturer does not comply with the EU2017/745 laws and regulations of the manufacturer, and the importer assume significant legal responsibility of the joint of the defective product, th
25、e importer can negotiate with the manufacturer to handle matters relating to recover the loss of later, if there is a dispute, is still unresolved consultation, the parties agree that the dispute submitted to Shenzhen Court of International Arbitration for arbitration in Shenzhen China, the arbitrat
26、ion procedures in Chinese.3) Liability Responsibility of the Importer3.1) Compliance with national and European legal and regulatory provisionsand all other provisions applicable to the ProductsThe importer undertakes to strictly comply with all legal, regulatory, and Europeanand possibly internatio
27、nal obligations in force applicable to the Products, and all otherapplicable provisions.3.2)The importer is obliged to comply with the requirementsDirective 93/42/EC modified by Directive 2007/47/EC (only for products benefiting from the Legacy device) and theEuropean regulation 2017/745, in particu
28、lar with:Registration in the EUDAMED databasewithin the time specified by the revelent laws and regulations;Shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the
29、 address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.Shall ensure that, while a device is under theirstorage or transportand otherconditions do not je
30、opardise its compliance with the general safety and performance requirements set out in Annex I oftheEuropean regulation 2017/745and shall comply with the conditions set by the manufacturer, where available.Importer who have received complaints or reports from healthcare professionals, patients or u
31、sers about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.Shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manu
32、facturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.(non-exhaustive list - refer to regulation 2017/745 Article 13).3.3)The importershall, in a manner that is proportionate to the risk class, type of device and the size of the enterprises, have measures in place to provide sufficient financial covera
