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Agreement between a single legal manufacturer and an authorized
AGREEMENT FOR AUTHORIZED
REPRESENTATIVE SERVICES Parties to the Agreement: Manufacturer: ……XXX Co., Ltd.… established in Address 1:…XXX. Postal Code: ……510655…………………. Country: ………PEOPLE’S REPUBLIC OF CHINA………… Telephone Number: …XXX…….. Fax Number: ……XXX……. and Authorized Representative: XXX Trading. established in Address 1 : XXX City : Jeddah Postal Code : P.O BOX- 22246 Country : Kingdom of Saudi Arabia Telephone Number: XXX Fax Number : N/A A. Definitions For the purpose of this agreement, the manufacturer shall be the natural or legal person responsible for the medical devices he intends to place on the KSA market under his name and for which he already has the necessary authorization to legally place these devices on the market in one of the XXX Founding Member jurisdiction. Furthermore, the definitions specified in the Medical Devices Interim Regulation and its Implementing Rules shall apply. B. Governing Law This agreement is subject to the laws of the KSA. C. Applicable Medical Device Regulation The Interim Regulation for Medical Devices, issued by the Saudi Food and Drug Authority Board of Directors’ Decree number 1-8-1429 dated 27 December 2008, published on 17 April 2009 in Umm AL-QURA Journal year 86 issue No 4249 and its relevant Implementing Rules. D. Tasks of the Authorized Representative The authorized representative shall: a. Represent the manufacturer in its dealings with the SFDA. b. List each medical device category or generic device group intended to be supplied to the KSA market, as required by Article 8 of the Implementing Rule MDS IR3 Medical Devices Listing. c. Complete the electronic marketing authorized application from posted on the SFDA website and provide the SFDA with all necessary supporting documentary evidence, required by Implementing Rule MDS-IR 6 Marketing Authorization. d. Cooperate with the SFDA on evaluations and actions taken during market surveillance and/or vigilance procedures described in Implementing Rule MDS - IR7 Post-marketing Surveillance. e. Make the following information available to the SFDA when so required in relation to its market surveillance activities: • The marketing authorization issued by the SFDA for the listed medical devices. • The documentation which was used to demonstrate compliance with the Regulation of the relevant GHTF founding member jurisdictions. • The documents approved by the SFDA demonstrating compliance with the specific Saudi provisions referred to in Article 6 of Implementing Rule MDS – IR 6 Marketing Authorization. f. Inform the SFDA of any adverse events that have occurred outside the KSA but have consequences for medical devices that have been authorized to be placed on the market of the KSA. The authorized representative shall explain the circumstances and provide information on the corrective action the manufacturer has taken or intends to take. g. Inform the SFDA of all field safety corrective actions resulting from post-market follow-up investigations performed by the manufacturer for medical devices that have been authorized to be placed on the market of the KSA. The authorized representative shall explain the reason for the corrective action and provide information on the action the manufacturer has taken or intends to take. h. Cooperate with parties involved in distribution activities, installation and maintenance of medical devices that have been placed on the KSA market under its mandate. E. Responsibilities of the Manufacturer The manufacturer shall: 1.1 Take all measures necessary to allow the execution of tasks delegated to A.R without delay. 1.2 Make available all necessary information relevant to SFDA regulations for medical devices as and when required. 1.3 Support to AR for medical device listing. 1.4 Make available all documentary evidence required for marketing Authorization of devices in KSA. 1.5 Cooperate with AR to fulfill obligations of medical device vigilance activities and post- marketing follow up described in Implementing rule MDS-IR7 on post-marketing surveillance. F. Medical Devices The manufacturer designates the authorized representative to act on its behalf for one or more of the medical device categories indicated in the table that follows.
G. Termination This agreement may be terminated by the manufacturer at any time provided it: a. maintains the continuous presence of an authorized representative to represent it within the KSA. and b. provides the authorized representative with a written notice of termination at least 45 days before the event. This agreement may be terminated by the authorized representative at any time provided it: undertakes to continue with the tasks specified in D until such time as the manufacturer appoints a licensed alternative to represent it within the KSA; and provides the manufacturer with a written notice of termination at least 90 days before the event. In the event of the SFDA terminating the authorized representative’s license, the authorized representative is expected to continue with the tasks specified in D until such time as the SFDA licenses an alternative authorized representative to represent the manufacturer within the KSA or for 90 days. H. Other Tasks and Provisions Additional to those Required for Au thorized Representative Licensing Additional Tasks of AR shall include: ü Consult with the manufacturer regarding, and act on behalf of the manufacturer in KSA in accordance with the manufacturer’s directions, in relation to the relevant provisions of the Medical Device Interim Regulation and the corresponding implementing rules. ü Without delay update the provided data / information to MDNR and MDEL, if there are any significant changes or as required by SFDA. ü Renewal or extension of marketing materials authorization on time. ü In cooperation with manufacturer, establish, document and implement the procedures necessary for performing mandated task and also make them available as and when required by SFDA. ü Inform the manufacturer about the additional provisions specific to the KSA concerning labeling and conditions of supply and / or use of the medical devices. ü Inform the manufacturer about any terms or deadlines of application and certifications set by the SFDA in due time. ü Without delay provide the manufacturer with the Establishment license and any modifications issues by SFDA. I. Application Date This agreement shall enter into force on 01/03/2021 J. Term of the Agreement This agreement shall remain in effect for 5 years from the date of application indicated in I, or until terminated by either party under the provisions of G. K. Attestation I, the undersigned, have the authority to accept the delegated tasks to be performed in the KSA, on behalf of the authorized representative named above, and ensure written procedures are applied to the tasks, where appropriate. Name: XXX Signed: ……………………….. Position in organization: Manager Date: ………………………….. I, the undersigned, have the authority to agree on behalf of the legal manufacturer who is party to this agreement, to take without delay all measures necessary to allow the execution of the tasks delegated to the authorized representative. I, the undersigned, declare that I have not designated any authorised representative other than that who is party to this agreement to act on my behalf for the medical devices listed in Section F. Name: ……XXX….. Signed: ……………………….. Position in organization: ……Sales & Marketing Manager…… Date: ………………………….. |
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AGREEMENT FOR AUTHORIZED 授权许可协议 沙特
涉外文件格式样本 | 2022-01-08 17:38AGREEMENT FOR AUTHORIZED 授权许可协议 沙特