Party A: Suzhou Kangheshun Medical Technology Co., Ltd   

Add:  Room 403-3, Building 29, 369 Lushan Road, Suzhou High-tech Zone, Suzhou Jiangsu P.R. China   

Contact:Shengsheng Chen(Mr.)

Tel: +86 512-66893470

Fax: +86512-82868669

Email:  sschen@innokare.com

 

Party B: SUNGO Cert GmbH,

Add: Harffstr. 47,40591 Düsseldorf, Germany

 

Contact: Frank Xu (Mr.)

 

Tel: +49 (0)211 97634133

 

E-mail: de.rep@sungogroup.com

 

Party A hereby appoints Party B as the EC authorized Representative for their Medical Device with CE mark and Party B accepts the appointment to be the EC authorized Representative for Party A in the market of European Union (E.U.). Both parties enter this agreement as follow:

 

1. Party A

1.1 Party A assures to provide the updated technical files of each product category with CE mark to Party B (Product categories relevant information please see the appendix A). Party A could firstly provide Part A of the technical file, and Part B would be submitted if required. If Party A can not provide the required technical file to Party B within 30 days after approval of CE certification or before using CE mark for “self declaration” products, this agreement will be terminated automatically, Party A should take on any aftereffect by itself. The technical files should be the electronic copy (PDF/WORD/JPG/TXT version), the written copy would be submitted if required by the competent authority. Detail of the requirements of the submitted files in appendix B.

 

1.2 Party A shall keep the Party B informed of any changes or updates of the mentioned information in attachment 1 at all times.

 

1.3 If any accident/near accident of products, including any serious adverse event during clinical investigation in premarket stage, happens within boundary of E.U., Party A shall help Party B to investigate the reason in time, and complete & submit the initial INCIDENT report together with Party B by using the standard ”Manufacturer’s Incident Report”, to the competent Authority within the timeframe required by the Section 5.1.7 of Guideline’s on a Medical Devices Vigilance System(MEDDEV 2.12-1 rev8, Jan, 2013), listed as follows: 

 

Serious public health threat: IMMEDIATELY (without any delay that could not be justified) but not later than 2 calendar days after awareness by Party A of this threat.

 

Death or UNANTICIPATED serious deterioration in state of health: IMMEDIATELY (without any delay that could not be justified) after party A established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness.

 

Others: IMMEDIATELY (without any delay that could not be justified) after Party A established a link between the device and the event but not later than 30 elapsed calendar days following the date of awareness of the event.

 

Party A shall present the investigation result and final report to Party B according to MDD 93/42/EEC (MDD products) ,IVDD 98/79/EC (IVDD products) and the Guidance of vigilance system. If the accident of the product happens out of E.U., 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 notify Party B in one working day 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 as soon as possible.

 

 

1.4 Party A should keep the complete sales list of all of the products exporting to any area of E.U. by electrical documents in English at least 5 years after the last batch product’s manufacturing, in order to be provided by Party B for the using to be transferred or inspected to the relevant competent authorities of E.U., Party A shall assure the accuracy and the validity of the data.

 

1.5 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 clause 1.4.

 

1.6 Party A should appoint one or two persons 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 appendix C.

 

1.7 Party A shall fully realize the risk of selling its products to EU market without product registration to relevant competent authority of E.C. If it caused by Party A, such as delay, omittance or conceal of files submission, Party A should take the aftereffects such as warning, penalty or even the results that the CE certificate will be withdrawn, and the distribution of its products in EU market will be prohibited.

 

1.8 Part A shall notify of the intention to Part B to carry out a clinical investigation for MDD or AIMDD, or the intention to carry out a performance evaluation for IVDD performed in EU.

 

2. Party B

2.1 About the register for Party A’s products with CE mark to relevant competent authority of E.C. (Details are in appendix D), Party A shall apply it in written to Party B and supply all the files and forms needed. Party B shall review it within 7 working days, and submit to competent authority of the country in which Party B is located (Germany) within 5 days. If Party A’s application is returned/rejected by Party B or the competent authority for the contents of the submitted files, the above schedule will be adjusted accordingly. The details of the application shall be in the attachments of this agreement. (The charges of products register in EU shall be paid accordingly by Party A and a contract may be signed separately if necessary.)

 

If it needs any expenditure by the competent authority, only after getting Party A’s approval, then Party A can take on the payment. If Party A’s products register fails by Party B’s reason, according to EU relevant laws Party B will be given a warning, penalty and even the qualification of the European Representative will be revoked.

 

2.2 Party B shall reserve technical files of each category of Party A's products with CE mark, and take up the responsibility of keeping, confidentiality and submission. The technical files shall be reserved at least 5 years after the last batch product’s manufacturing. Once competent authority needs the technical files (including new edition technical files which had already registered) of each category of Part A’s products with CE mark. Party B should send them to competent authority within ten working days.

 

2.3 Party B would not be responsible for the file content. All the documents, such as sales list and complain records are deemed confidential information; Party B have the obligation to send them to competent authority if necessary. Part B should maintain and keep them secret.

 

2.4 Party B permits Party A to use part B’s name and address for the purpose of inclusion/printing on all packaging, labeling and instruction for use, of products that carry CE Marking and that have been represented by Party B.

 

2.5 Party B shall keep following files of party A’s products with CE mark at the disposal of the national authorities, at least five years after the last batch product’s manufacturing. Minimum documents are:

1) Declaration of conformity,

2) Copy of the label, packaging and instructions for use (in all languages requested by the countries where the device is marketed),

3) Notified Body certificate (where relevant),

4) Post market surveillance process and data, vigilance reports and complaints, processes and data,

5) Technical documentation relevant to market surveillance investigation being undertaken by the Member State,

6) Relevant clinical data / notification,

7) Details of any distributors / suppliers putting the CE marked devices on the market,

8) Incident reports and corrective actions taken.

 

2.6 Party B must keep Party A informed in all matters that may be connected to the devices placed on the market in the EU. At the minimum, the exchange of information concerning following shall be covered.

 

2.6.1Safeguard Clause

“Where a Member State ascertains that a medical devices, when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.”

If the relevant Competent Authority contacts the Party B about its interim measures to withdraw Party A’s device(s) from the market or prohibit or restrict their being placed on the market or put into service, Party B should immediately communicate such measures to Party A and advise Party A as to the implications of this decision.

When the Commission finds that national measures taken under the Safeguard Clause “are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorized representative”.

If the relevant Competent Authority contacts Party B, Party B should immediately communicate such information to Party A and advise Party A as to the implications of this decision.

 

2.6.2Vigilance

If the relevant Competent Authority contacts Party B about its assessment outcome of an incident of Party A’s medical device, Party B should immediately communicate such information to the manufacturer and advise Party A as to the implications of this decision.

 

Party B shall notify any information about the products with CE mark within boundary of E.U. to Party A, including any claims of customers and the competition company that produce the same CE marked products.

 

2.6.3If any accident/ near accident of products (CE marked products, premarket clinical investigation products and performance evaluation products) happens within boundary of E.U., Party B shall notify Party A within 3 working days after receiving the claims of customers and feedback about the product, and execute vigilance system of medical device products under the assisting of Party A, and also make initial report, investigation result and final report to competent authority of country in which the accident happens.

 

2.7 Party B shall assist Party A to comprehending the condition of the same products within boundary of E.U, and send the related information to Party A in time.

 

2.8 Upon receiving the notice about the intention to carry out a clinical investigation for MDD or AIMDD, and the intention to carry out a performance evaluation for IVDD in EU, Party B shall notify communicate the information on the manufacturer and on the device to the Competent Authorities of the Member State in which he has his registered place of business. If any serious adverse events during clinical investigation, i.e. in the premarket phase, Party B Shall fully record and immediately notify to all Competent Authorities of the Member States in which the clinical investigation is being performed.

 

2.9 Party B shall appoint one or two persons as the primacy linkman whose responsibility is to connect with Party A and deal with the normal daily grind according to this agreement. The information of both Parties’ linkman was written in appendix C.

 

2.10 Once this agreement is signed, Party B will provide Party A regular services include: daily mail telephone reply, quarterly sales record collection, annual checklist collection and EC REP Publications.

 

2.10.1Both parties agree that EC REP will charge additional service fees of the following situations (including but not limited to). The fees will be charged based on the situation and negotiation:

1) Need Party B to continuous track of the investigation or complaint events by EU competent authorities

2)Due to the manufacturer's mistake, after exporting to the EU, it was told by EU competent authorities that it was necessary to pay a fine

3) An accident of Party A’s medical devices in the EU and needs to be handled by Party B.

4) When the incident happened, Party B is required to guide the filling of MIR Report

5)After the signature and seal of both parties of this agreement come into effect, Party A needs to modify the information for its own reasons.

 

2.10.2 After Party B receives the case email from EU authorities, Party B needs to give timely feedback to Party A and ask Party A to give a reply within the specified time. If Party A's reply has not been received and no explanation has been given, Party B has the right to terminate this Agreement and cancel the EU registration.

 

3. Jurisdiction & Duration

3.1 This agreement is subject to the laws and jurisdiction of Germany.

 

3.2 This agreement becomes immediately effective from the signature date of Company A, and the valid as follows:

3.3 During the implementation of the agreement, this agreement will be terminated automatically when:

1) The day upon Part A’s CE Certificate be withdrawn temporarily, be closed or be recalled by the notified body.

2）Party A can not provide the required technical file to Party B within 30 days after approval of the CE certification or before using CE mark for “self declaration” products. During 60 days from the date of this agreement terminated, Party A could transact the routine affairs as the authorized European Representative while Party A could appoint new European Representative and change the CE certification. Party B should report the invalid agreement to the notify body for record.   

3）Party A doesn’t payoff the service fee according to this agreement and refuse to explain on the deadline.

 

 

 

 

 

 

 

 

Company A: _____________       __________________

       Date      Signature

 

 

 

 

Company B: _____________        __________________

       Date      Signature

Appendix A

 

For the following product categories: