Authorised Representative Licensing Presented By Eng Abdullah S

Authorised Representative Licensing Presented By: Eng. Abdullah S. Al Dobaib Registration and Licensing Executive Department , MDS 1 3/16/2018 11: 20 AM

Roadmap Premarket Approval Medical Device Sector Saudi Food and Drug Authority

MDS Roadmap MDNR Number IMPORTER AR MDNR AR application Importer &distributer application E. License MDEL MDMA Market Authorizati on DISTRBUTER AR Local Manuf.

Authorised Representative Licensing 4 3/16/2018 11: 20 AM

Authorized Representative Documents - updated version 5

Authorised Representative (AR) Definition: • Authorised Representative (AR): means any natural or legal person established within the KSA who has received a written mandate from the manufacturer to act on his behalf for specified tasks including the obligation to represent the manufacturer in its dealings with the SFDA. (Article 1, Chapter 1, MDIR) 6

General Principles • When the manufacturer is located outside the KSA he shall appoint an authorised representative to act on his behalf. (Article 11, MDIR) • Chapter Six of the Medical Devices Interim Regulation requires organisations authorised by a manufacturer to act on his behalf in the KSA to have an establishment license for this activity, issued by the SFDA. (Article 4 A, MDS-IR 5) 7

Activities to be performed by an AR Part I: Pre-License Activities Ø Designation of Authorized Representatives Ø Applying for establishment registration Ø Mandate between the manufacturer and Authorized Representative Part II: Applying for a License Applying for establishment Licensing Part III: Post-License Activities of Authorized Representatives Ø Medical Device Marketing Authorization – General Provisions Ø Post-Marketing Responsibility for Advertising and Marketing Material Ø Post-Marketing Surveillance of Medical Devices 8

Part I: Pre-License Activities Ø Designation of Authorized Representatives A. The mandate established between the manufacturer and the authorized representative shall be in writing, specify the mandated activities and be subject to the laws of the KSA. (Article 6 A, MDS-IR 5) 9

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative ØSingle Site and Multiple sites • • Two Samples agreement developed in Guidance 3 I, the undersigned, as party to this agreement, have the authority to agree on behalf of the manufacturers listed below, for them to take without delay all measures necessary to allow the execution of the tasks delegated to the authorized representative. Moreover, I accept the commitment to ensure each one of the listed manufacturers has a copy of this agreement and is aware of its particular tasks and responsibilities under its provisions. ( multiple sites) 10

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative B. The minimum content of the contract (the ‘mandate’) between the manufacturer and the authorized representative is specified in Article Six of Implementing Rule MDS-IR 5. 1) Represent the manufacturer in its dealings with the SFDA. 2) List each medical device category or generic device group intended to be supplied to the KSA market. 3) Complete the marketing authorization application form. 4) Cooperate with the SFDA on evaluations and actions taken during market surveillance and/or vigilance procedures. 5) Make any information available from the technical file to the SFDA when so required. (Article 6 B, MDS-IR 5) 11

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative 6) Inform the SFDA of any adverse event that have occurred outside the KSA but have consequences for medical device that have been authorized to be placed on the KSA market. 7) Inform the SFDA of all field safety corrective actions resulting from post-market follow-up investigations performed by the manufacturer. 8) Cooperate with parties involved in distribution activities, installation and maintenance of medical devices that have been placed on the KSA market under its mandate. (Article 6 B, MDS-IR 5) 12

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative ØMedical Device Category or Generic Device Group C. Where a manufacturer intends to make available more than one category or generic device group of medical device to the KSA, it may either designate a single authorized representative for all the devices it intends to market, or designate a different authorized representative for each device category or generic device group. (Article 6 B, MDS-IR 5) 13

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative ØMedical Device Category or Generic Device Group • Device category : Is the broadest level of medical device nomenclature. Category Reusable devices Anesthetic and respiratory devices Single-use devices Dental devices Assistive products for persons with disability Electro mechanical medical devices Diagnostic and therapeutic radiation devices Hospital hardware Complementary therapy devices In vitro diagnostic devices Biologically-derived devices Non-active implantable devices • Active implantable devices Healthcare facility products and adaptations Ophthalmic and optical devices Laboratory equipment Generic device group: means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics. Device Category Generic device group 14

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative ØMedical Device Category or Generic Device Group I, the undersigned, declare that I have not designated any authorized representative other than that who is party to this agreement to act on my behalf for the medical devices listed in Section F. 15

Part I: Pre-License Activities Mandate between the manufacturer and Authorized Representative Ø Other tasks and provisions • Other Tasks and Provisions Additional to those Required for Authorized Representative Licensing are not assessed by the SFDA when it licenses the authorized representative. • AR will be Acting on behalf of the Manufacturer for the medical device within the KSA according to the AR agreement with the exception to the paragraph pertaining aadditional tasks and Provisions 16

Other activities E. Where the Authorized Representative is also involved in importation or distribution activities of medical devices within the KSA, it is subject to the additional requirements and responsibilities (MDS – IR 4 Establishment Licensing) 17

Part I: Pre-License Activities D. The authorized representative shall have separate mandate and license for each manufacturer it represents within the KSA. License Authorized representative License (Article 5 C, MDS-IR 5) 18

Requirements 1. A copy of the mandates. 2. Copies of the procedures that support each of the activities specified in the manufacturer’s mandate. 3. Application fees , 5200 SR for each mandate , to be paid through SADAD system. 19

Part II: Applying for a License Applications for Medical Devices Systems can be applied online through The Medical Device Electronic Services. 1 st. Apply for Establishment registration and obtain MDNR number through MDNR system. 2 nd. Apply for Authorized Representative license online through MDEL system. 20

MDNR In order to be able to access Authorised representative application through MDEL system , you must select Authorised Representative as an establishment type on MDNR system 21

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Online application The AR Application consists of Three Main sections: Section A: Company Details Section B: Authorized Contact Person Section C: Manufacturer and device categories 23

Please note that sections A and B will be retrieved from the MDNR. Section C : 1. Add Manufacturer 2. Save the application 3. Add device category NOTE : To add sub sites 24

Please note that sections A and B will be retrieved from the MDNR. Section C : 1. Add Manufacturer 2. Save the application 3. Add device category 4. attestation 5. Sumbission 25

Payment 1. 2. 3. 5200 for each mandate. Though SADAD system. One month period to proceed with the payment 26

Application cycle Renewal New application expired Saved Submission One year licensed Under study Issuing Open Paid Closed 27 Wait for payment Rejected Through SADAD Assessment ( 20 working days)

Establishment license Only an authorised representative holding a valid establishment license, issued by the SFDA, is permitted to legally act on behalf of the manufacturer in relation to the relevant provisions of the Medical Device Interim Regulation and the corresponding Implementing Rules. License Annexes 28

Part III: Post-License Activities of Authorized Representatives Ø Medical Device Marketing Authorization (MDS – IR 6 Marketing Authorization) Ø Post-Marketing Responsibility for Advertising and Marketing Material ü The overseas manufacturer through its authorized representative is responsible for ensuring all advertising and marketing materials are approved by the SFDA before they are used. (II. Advertising, Article 39, Chapter 10, MDIR) 29

Part III: Post-License Activities of Authorized Representatives Ø Post-Marketing Surveillance of Medical Devices – Cooperate with the SFDA on evaluations and actions taken during Post-marketing surveillance (MDS – IR 7 Postmarking surveillance) – Cooperate with parties involved in distribution activities, installation and maintenance of medical devices that have been placed on the KSA market under its mandate. 30

Termination Authorized representative is expected to continue with the mandated tasks until such time as the SFDA licenses an alternative authorised representative to represent the manufacturer within the KSA. 31

Security and Confidentiality of Data • All data submitted online will be protected and encrypted via the MDEL security infrastructure. • All data provided will be used by SFDA. 32

The Validity of a License • The issued license has a validity of One year. • The system automatically generates notification • for renewal through the email to the establishment 30 days before the license end. Any changes to the provided information has to be submitted to SFDA within 10 days of the date of the change occur. √ 33

Refusal of an Establishment License A. The SFDA shall refuse to issue a license for an authorized representative if the mandated tasks and/or the proposed procedures are insufficient to ensure the proper implementation of the Medical Device Interim Regulation and this Implementation Rule. (Article 9 A, MDS-IR 5) B. If the SFDA intends to refuse the license, it shall notify the applicant in writing of the reasons of the refusal and information of the procedure to appeal the action taken. (Article 9 B, MDS-IR 5) 34

Suspension of an issued license ED ED EN SP B. The SFDA shall suspend the license of an authorised representative if it is of the view that he has not correctly fulfilled the mandates tasks. (Article 10 A, MDS -IR 5) SU A. The SFDA shall suspend the license of an authorized representative if it has reasonable grounds to believe that the licensee has contravened any of the relevant provisions of the Medical Devices Interim Regulation, or of the Implementing Rule 5 , or has made a false or misleading statement in its application. (Article 10 A, MDS-IR 5) 35

Corrective action 1. Before suspending a license, the SFDA shall send the licensee a notice that sets out the reason for the intended suspension and, if appropriate, corrective actions to be taken as well as the time during which they shall be implemented. (Article 10 C, MDS-IR 5) 2. The suspended license shall be reinstated if the situation that gave rise to its suspension has been properly corrected. (Article 10 D, MDS-IR 5) 3. If the required corrective actions have not been adopted in due time, the license shall be withdrawn. (Article 10 E, MDS-IR 5) 4. The SFDA shall provide information to the licensee on the procedure to appeal the action taken. (Article 10 F, MDS-IR 5) 36

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