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MDS-REQ 5 Requirements on Importation and Shipments Clearance of Medical Devices Version Number: 6.0 Version Date: 19/7/2023 “Translated Copy” Page 1 of 44 MDS-REQ-005-V5/230719

Table of Content Introduction __________________________________________________________________ 3 Purpose ____________________________________________________________________ 3 Scope _____________________________________________________________________ 3 Background ________________________________________________________________ 3 Requirements _________________________________________________________________ 4 Importation for Circulation of Medical Devices ___________________________________ 4 Importation of Used Medical Devices ____________________________________________ 5 Importation for Local Manufacturing ____________________________________________ 6 Importation for Clinical Studies _________________________________________________ 7 Importation for Research and Education __________________________________________ 8 Importation for Demonstration __________________________________________________ 9 Importation for National Emergency ____________________________________________ 10 Importation for Humanitarian Purposes (including Custom-Made Medical Devices) ______ 11 Personal Importation ________________________________________________________ 12 Free Sale Certificate _________________________________________________________ 13 Required Documents __________________________________________________________ 14 Annexes ____________________________________________________________________ 23 Annex (1): Declaration and Attestation of Medical Devices Users _____________________ 24 Annex (2): Declaration and Attestation of Importers ________________________________ 25 Annex (3): Declaration and Attestation of Health Practitioner ________________________ 30 Annex (4): Declaration and Attestation of Beneficiaries of Research Products____________ 32 Annex (5): Declaration and Attestation for Healthcare Provider for Importing in National Emergency ________________________________________________________________ 33 Annex (6): Application Form of Free Sale Certificate _______________________________ 34 Annex (7): Medical Devices Shipments Procedures ________________________________ 37 Annex (8): Declaration of Conformity for the Shipment to Medical Devices Law and its Executive Regulation ________________________________________________________ 40 Annex (9): Definitions & Abbreviations _________________________________________ 41 Annex (10): List of Changes on the Previous Version _______________________________ 43 Page 2 of 44 MDS-REQ-005-V5/230719

Introduction Purpose The purpose of this document is to specify and clarify the requirements of importation and shipments clearance of medical devices. Scope This document applies to medical devices and their accessories to be imported. Note: This document does not apply to the following: − Medical imaging materials (MDS-REQ4) − Particle accelerators for radioisotope genesis for medical applications (MDS-REQ4) − Radioactive materials used in medical applications (MDS-REQ6) − Minimally manipulated biological products intended for human application − Spare parts of medical devices A classification request for the products may be submitted through services of products classification , in order to know whether they are subject to SFDA/MDS regulation or not Background SFDA has issued this document in reference to the following: A. Articles (3), (6), (18), (11), (12), (13) and (20) of the "Law of Medical Devices" and "Implementing Regulation of Medical Devices Law". B. Announcement No. (47084) dated 12/6/1440 H regarding to keeping the original required documents of Shipment Clearance. Page 3 of 44 MDS-REQ-005-V5/230719

Requirements Importation for 1 For importing medical devices for the circulation purpose, the Circulation of following shall be obtained: Medical Devices 1) MDMA (see MDS-REQ1) Notes: − For importing medical device accessories, they shall have a “Medical Devices National Listing Number” mentioned in the MDMA. − For importing refurbished medical devices, they shall have MDMA after refurbishment, in addition to the previous MDMA. 2) Importer License (See MDS-REQ9) 3) Importation License/Permission (in case of they are chemicals classified as medical devices, including IVDs), according to: − It shall not contain any of the chemicals mentioned in the the Chemical Weapons Convention. − The quantity to be imported shall be according to the establishment’s needs for a period of one year. − Abiding by the provisions of declaration specified in Annex (2) − Submitting the application via GHAD system with providing the "Required Documents” - section (1). − Once satisfied, the SFDA issues an importation license/permission, valid for (1) year, taking into account the validity of the MDMA. 4) Approval for releasing shipment before it arrives at a port of entry, according to: − The devices shall have an AR holding a valid license, the importer can confirm this by contacting the manufacturer or SFDA. − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 4 of 44 MDS-REQ-005-V5/230719

Importation of 2 Used medical devices shall not be imported unless the purpose of Used Medical importing is one of the following: Devices A. Returning it to the KSA (after it has been maintained, calibrated, displayed as marketing samples, corrected according to a safety warning notice that requires it, or tested outside the KSA), it will be cleared from customs according to the customs declaration of exportation within (6) months from the exportation date. B. Refurbishing or maintaining them in the KSA and then re- exporting them, for importing them, the following shall be obtained: 1) Importation License/Permission, according to: − Abiding by the provisions of declaration specified in Annex (2) − Submitting the application via GHAD system with providing the "Required Documents” - section (2). − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 2) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Note: When re-exporting, they are cleared by customs according to the issued “Importation License/Permission” within (6) months. Page 5 of 44 MDS-REQ-005-V5/230719

Importation for 3 For importing semi-finished medical devices (and raw and non-raw Local chemicals) for the purpose of local manufacturing (manufacturing Manufacturing includes refurbishing, assembling, packaging, and labelling), the following shall be obtained: 1) Importation License/Permission, according to: − Quantity to be imported shall be corresponds to the production output. − Quantity to be imported shall be according to the establishment’s needs for a period of one year. − Medical devices shall obtain MDMA after their manufacture and before circulation/marketing (see MDS-REQ1). − Abiding by the provisions of declaration specified in Annex (2) − Applicant shall be an establishment holding a manufacturer license (MDS-REQ9), or industrial license if the applicant is a new manufacturer that has not started production yet. − Submitting the application via GHAD system with providing the "Required Documents” - section (3). − Once satisfied, the SFDA issues an importation license/permission, valid for (1) year. 2) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 6 of 44 MDS-REQ-005-V5/230719

Importation for 4 For importing medical devices for pre-marketing clinical studies Clinical Studies purpose, the following shall be obtained: 1) Approval (No Objection Letter) for Conducting the Clinical Trial (See MDS-REQ2) 2) Importation License/Permission, according to: − Abiding by the provisions of declaration specified in Annex (2) − Submitting the application via GHAD System with providing the "Required Documents” - section (4). − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 3) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 7 of 44 MDS-REQ-005-V5/230719

Importation for 5 For importing medical devices for non-clinical research and education Research and purpose, the following shall be obtained: Education 1) Importation License/Permission, according to: − Abiding by the provisions of declaration specified in Annex (2) − Abiding by the provisions of declaration specified in Annex (4) − Applicant shall be one of the following:  Establishment holding an importer license (See MDS-REQ9)  Establishment holding a manufacturer license (See MDS-REQ9)  Healthcare provider registered in the GHAD system.  Educational facility registered in the GHAD system  Research center registered in the GHAD system  Independent researcher registered in the GHAD system. − Submitting the application via GHAD system with providing the "Required Documents” - section (5). − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 2) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 8 of 44 MDS-REQ-005-V5/230719

Importation for 6 For importing samples medical devices used in exhibitions, festivals Demonstration or workshops for the purpose of demonstration, the following shall be obtained: 1) Importation License/Permission, according to: − The advertisement of medical devices that have not obtained MDMA is prohibited. Only specialized persons can be informed about such details. − Abiding by the provisions of declaration specified in Annex (2) − Applicant shall be one of the following:  Establishment holding an importer license (MDS-REQ9)  Healthcare provider registered in the GHAD system.  Facilities organizing exhibitions registered in the GHAD system  Educational facility registered in the GHAD system  Other relelavent establishment registered in the GHAD system − Submitting the application via GHAD system with providing the "Required Documents” - section (6). − Once satisfied, the SFDA issues an importation license/permission, valid for (6) months. 2) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via the “FASAH (Tabadul)” platform, and provide the “Required Documents” - section (10). Page 9 of 44 MDS-REQ-005-V5/230719

Importation for 7 For importing medical devices in national emergency situations (e.g. National natural disaster, war, or epidemics) for the own use of healthcare Emergency providers, the following shall be obtained: 1) Importation License/Permission, according to: − It shall not have an alternative that has obtained MDMA unless there is a justification. − It shall only be imported from an establishment holding an importer license (see MDS-REQ9) unless there is justification. − Abiding by the provisions of declaration specified in Annex (2) − Abiding by the provisions of declaration specified in Annex (5) − Submitting the application via GHAD system with providing the "Required Documents” - section (7). − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 1) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 10 of 44 MDS-REQ-005-V5/230719

Importation for 8 For importing medical devices for the humanitarian purpose, the Humanitarian following shall be obtained: Purposes 1) Importation License/Permission, according to: (including Custom-Made − Medical device intended to be imported shall be custom- Medical Devices) made, or not available in the KSA (not suitable for patient treatment, or intended to be used in emergency cases), and according to the request and responsibility of a healthcare professional. Note: “Patient-Specific Medical Device” and “Adaptable Medical Devices” are excluded, and they shall have obtain MDMA. − A separate application shall be submitted for each patient. − For importing custom-made medical devices, labels of medical device shall include that it is custom-made in Arabic and/or English. − Abiding by the provisions of declaration specified in Annex (2) − Abiding by the provisions of declaration specified in Annex (3) − Submitting the application via GHAD system with providing the "Required Documents” - section (8). − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 2) Approval for releasing shipment before it arrives at a port of entry, according to: − Complying with the “Medical Devices Shipments Procedures” in Annex (7), when applicable. − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the “Required Documents” - section (10). Page 11 of 44 MDS-REQ-005-V5/230719

Personal 9 For importing medical devices for the personal use, the following Importation shall be obtained: 1) Importation License/Permission, according to: − Medical devices shall be home-use and intended for lay persons, unless there is justification. − Quantity shall be limited and the single shipment shall not exceed (3) months of use, and the total number of shipments shall not exceed (5) shipments for each calendar year, unless there is justification, according to a medical report indicating the quantity required for use. − Medical devices shall not to be used for commercial purposes. − Abiding by the provisions of declaration specified in Annex (1). − Submitting the following via GHAD system:  Medical report (when required)  Declaration specified in Annex (1)  Information of the medical device (e.g. purchase invoice, catalog, website screenshot) − Once satisfied, the SFDA issues an importation license/permission, valid for (3) months. 2) Approval for releasing shipment before it arrives at a port of entry − Submitting the application via Faseh Services System (SFDA) − Submitting the application via the FASAH (Tabadul) platform − Providing the issued “ Importation License/Permission” according section (1) above. Note: If the request of importation license/permission includes chemical substances that falls under MOI control, SFDA will refer the request to the MOI represented by the HCIS (Central Licensing Unit), and provide the reference number to the applicant for the follow up. The HCIS will be responsible for issuing importation license/permission, and approval for releasing shipment. Page 12 of 44 MDS-REQ-005-V5/230719

Free Sale 10 Manufacturer can, upon its request, obtain “Certificate of Free Sale” Certificate according to: − Medical devices shall be hold MDMA (see MDS-REQ1). − Abiding by the provisions of declaration specified in Annex (6) − The KSA market shall not be affected by medical devices exportation and there shall be no delay in the supply of market requests, or requests of healthcare providers, and shall have sufficient supply of the devices when exported. − Applicant shall hold a manufacturer license (see MDS-REQ9). − Submitting the application via <IM.MDS@SFDA.gov.sa> with providing the "Required Documents” - section (9). − Once satisfied, the SFDA issues an certificate, valid for (1) year, taking into account the validity of the MDMA. Page 13 of 44 MDS-REQ-005-V5/230719

Required Documents Required Documents Notes (1) Required Documents for License of Importing for Circulation 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number (not required In case of annual needs), manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any 5 Importer License − It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 6 Civil Defense License − If it is not available, provide the PO from the beneficiary − If the importer is a government entity, provide Civil Defense Approval of instead of the license 7 Material Safety Data Sheet − It shall be issued by the manufacturer 8 Chemical details in terms of weight or − Required only if the product contains volume chemical substances under MOI control − It shall be issued by the manufacturer − Measuring unit shall be in Kilogram or Liter − Quantity shall be for annual needs Page 14 of 44 MDS-REQ-005-V5/230719

9 Application and attestation forms − Required only if the product contains required, for chemicals importation, by chemical substances under MOI control MOI that are specified in Article Two − The attestation of responsible person for of “Regulation for Law of Chemicals chemical warehouse shall contain his Import and Management” contact information − They shall contain storage warehouse location (Sketch) 10 Medical Devices Marketing − Authorization (MDMA) 11 AR License − Automatically verified without the need to provide it in the application − It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 (2) Required Documents for License of Importing Used Medical Devices 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Bill Of Lading − If any 3 Country of Origin Certificate − If any (3) Required Documents for License of Importing for Local Manufacturing 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number (not required In case of annual needs), manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any Page 15 of 44 MDS-REQ-005-V5/230719

4 Country of Origin Certificate − If any 5 Manufacturer License − Instead, an industrial license is required in if the applicant is a new local manufacturer that has not started production yet, with a declaration proving that. − Local manufacturer under construction are excluded − For more information, see MDS-REQ9 6 Evidence that the product is classified − Not required for importing raw and non- as a medical device raw chemicals used in the manufacture of medical devices which within the production plan − Evidence may be a declaration of conformity (DOC), or a product classification decision issued by the SFDA, see services of products classification 7 Material Safety Data Sheet − It shall be issued by the manufacturer 8 Chemical details in terms of weight or − Required only if the product contains volume chemical substances under MOI control − It shall be issued by the manufacturer − Measuring unit shall be in Kilogram or Liter − Quantity shall be for annual needs 9 Application and attestation forms − Required only if the product contains required, for chemicals importation, by chemical substances under MOI control MOI that are specified in Article Two − The attestation of responsible person for of “Regulation for Law of Chemicals chemical warehouse shall contain his Import and Management” contact information − They shall contain storage warehouse location (Sketch) (4) Required Documents for License of Importing for Clinical Studies 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number, manufacturer name, product name, model number, lot/serial numbers, quantity, and Page 16 of 44 MDS-REQ-005-V5/230719

expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any 5 Importer License − It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 6 SFDA Approval (No Objection Letter) − for Conducting the Clinical Trial (5) Required Documents for License of Importing for Research and Education 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any 5 Importer License or Manufacturer − The following are excluded: License o Healthcare providers o Educational facilities o Research centers o Independent researchers Page 17 of 44 MDS-REQ-005-V5/230719

− It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 6 Declaration of Beneficiaries of − See Annex (4) Research Products 7 Beneficiary PO − Required only if there is no a label, fixed by the manufacturer, include that the device is for educational or research use only 8 Manufacturer letter clarifying the − Required only if the importer is a local importation purpose manufacturer − It shall include that the medical device is imported for non-clinical research purpose, and that the manufacturer has a research and development unit (6) Required Documents for License of Importing for Demonstration 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number, manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any 5 Importer License − The following are excluded: o Facilities organizing exhibitions o Healthcare providers o Educational facilities o Other relevant facilities Page 18 of 44 MDS-REQ-005-V5/230719

− It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 6 Label of the medical device indicates − It shall include a phrase indicating the use that it is for demonstration purposes purpose of use, such as: (For Demo Only) only and not for sale and (Not for sale) 7 Labeling of medical device − It includes: o Label affixed to a medical device or any of its containers or wrappers o Instructions for Use (IFU) 8 Evidence that the product is classified − Evidence may be a declaration of as a medical device conformity (DOC), or a product classification decision issued by the SFDA, see services of products classification (7) Required Documents for License of Importing for National Emergency 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number, manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any 5 Importer License − The exception is made when there is justification − It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 Page 19 of 44 MDS-REQ-005-V5/230719

6 Declaration of Healthcare Provider − See Annex (5) 7 Declaration of Conformity (DOC) − Declaration of conformity with the regulatory requirements of one of the following (Australia, Canada, Japan, the USA and the EU/EFTA) − Not required if acceptable justification is provided 8 Material Safety Data Sheet − It shall be issued by the manufacturer 9 Chemical details in terms of weight or − Required only if the product contains volume chemical substances under MOI control − It shall be issued by the manufacturer − Measuring unit shall be in Kilogram or Liter − Quantity shall be for annual needs 10 Application and attestation forms − Required only if the product contains required, for chemicals importation, by chemical substances under MOI control MOI that are specified in Article Two − The attestation of responsible person for of “Regulation for Law of Chemicals chemical warehouse shall contain his Import and Management” contact information − They shall contain storage warehouse location (Sketch) (8) Required Documents for License of Importing for Humanitarian Purposes (including Custom-Made Medical Devices) 1 Declaration of Importers − See Annex (2) − It shall be signed by authorized person identified in GHAD system 2 Purchase Invoice − If it is not available, provide the Pro Forma − It shall include involve number, manufacturer name, product name, model number, lot/serial numbers, quantity, and expiry date (if applicable) in the purchase invoice or packing list − It shall be issued by the manufacturer, if it is not, the applicant shall provide a copy of the agreement/authorization letter between the manufacturer and the establishment that issued the invoice, and it shall be stamped by the concerned authority for trade in the country of origin (if applicable) 3 Bill Of Lading − If any 4 Country of Origin Certificate − If any Page 20 of 44 MDS-REQ-005-V5/230719

5 Declaration of Health Practitioner − See Annex (3) 6 Healthcare professional’s written − Required only for importing custom-made prescription medical devices − It means healthcare professional’s written prescription which gives specific design characteristics for the sole use of a particular patient at the health professional responsibility (9) Required Documents for Free Sale Certificate 1 Application Form of Free Sale − See Annex (6) Certificate 2 Medical Devices Marketing − Automatically verified without the need to Authorization (MDMA) provide it in the application − For more information, see MDS-REQ1 3 Manufacturer License − For more information, see MDS-REQ9 (10) Required Documents for Shipments Clearance 1 Purchase Invoice − It shall be authenticated by the chamber of commerce in the country of origin − It shall contain the invoice number, manufacturer’s name, products name, quantity, and unit price − Model/part numbers and lot/serial numbers shall be indicating in the invoice or packing list − In case the shipment requires data logger (sensor/reader/indicator) according to manufacturer instructions, the serial number of the data logger shall be indicated in any of shipment documents (such as an invoice or bill of lading) 2 Bill Of Lading − In case the shipment requires data logger (sensor/reader/indicator) according to manufacturer instructions, the serial number of the data logger shall be indicated in any of shipment documents (such as an invoice or bill of lading) 3 Customs Declaration − 4 Medical Devices Marketing − Required only for importing medical Authorization (MDMA) devices for the purpose of circulation Page 21 of 44 MDS-REQ-005-V5/230719

− The MDMA shall be valid, noting that it can be renewed 90 days before its expiration − For more information, see MDS-REQ1 5 AR License − Required only for importing medical devices for the purpose of circulation, it is automatically verified without the need to provide it in the application − The MDMA shall be valid, noting that it can be renewed 90 days before its expiration − For more information, see MDS-REQ9 6 Importer License − Required only for importing medical devices for the purpose of circulation − Automatically verified without the need to provide it in the application − It shall be valid, noting that it can be renewed 60 days before its expiration − For more information, see MDS-REQ9 7 Declaration of Conformity − Required only for importing medical to Medical Devices Law and its devices for the purpose of circulation Implementing Regulation − See Annex (8) − This declaration is different than the declaration of conformity provided for purpose of obtaining MDMA 8 Importation License/Permission − Not required for importing medical devices for the purpose of circulation and contain chemical substances Page 22 of 44 MDS-REQ-005-V5/230719

Annexes Page 23 of 44 MDS-REQ-005-V5/230719

Annex (1): Declaration and Attestation of Medical Devices Users Click here for printable and editable version Name of Device: : ‫املستلزم الطبي‬/‫اسم الجهاز‬ Quantity: :‫الكمية‬ Country of Shipment: :‫بلد الشحن‬ Carrier: :‫الشركة الناقلة‬ :‫مسوغ الشراء‬ Justifications: Purchase method: :‫طريقة الشراء‬ o Through Internet: Write the the name ‫ اكتب اسم املوقع‬:‫ عبر االنترنت‬o of the site …………………………… .............................................................. o Other: …………………. ................................................. :‫ أخرى‬o ‫أتعهد بأن األجهزة واملستلزمات الطبية املذكورة في الطلب هي لالستخدام الشخص ي فقط وليست لالستخدام ألي غرض‬ ‫ لذا أتحمل كامل‬،‫ كما اقر بأني على علم أن الهيئة العامة للغذاء والدواء ال تضمن سالمتها أو كفاءتها أو جودتها‬.‫آخر‬ .‫ كما اقر بأن جميع املعلومات املقدمة صحيحة‬.‫املسؤولية في حال نتج عن استخدامها أي مخاطر‬ I declare that mentioned medical device (s) are for personal use only, and not intended to be used for any another purpose. I also understand that the Saudi Food & Drug Authority (SFDA) can give no guarantee as to the safety, effectiveness, or quality of the above medical device (s). Therefore, I will take full responsibility for all hazards or risks due to usage. I also declare all provided information is correct. Name of User’s Device: :‫اسم مستخدم الجهاز‬ Mobile Number: :‫رقم الجوال‬ ID/Passport No.: :‫الجواز‬/‫رقم الهوية‬ E-mail: :‫البريد اإللكتروني‬ National Address: :‫العنوان الوطني‬ Date: :‫التاريخ‬ Signature :‫التوقيع‬ Page 24 of 44 MDS-REQ-005-V5/230719

‫‪Annex (2): Declaration and Attestation of Importers‬‬ ‫‪Click here for printable and editable version‬‬ ‫]‪[To be printed on Manufacturer Letterhead‬‬ ‫أ) بيانات املنشأة‬ ‫اسم الشركة‪/‬املؤسسة‪/‬املستودع‪/‬املستشفى‬ ‫رقم املعرف في نظام غد‬ ‫ب) بيانات األجهزة واملستلزمات الطبية (حسب بيانات الفاتورة)‬ ‫بلد الصنع‬ ‫تاريخ الفاتورة الشركة املصنعة‬ ‫الكمية‬ ‫رقم الفاتورة‬ ‫اسم البند‬ ‫‪1‬‬ ‫‪2‬‬ ‫‪3‬‬ ‫‪...‬‬ ‫ج) محتويات الجهاز واملستلزم‬ ‫اسم املادة (عند اإلجابة بنعم)‬ ‫نعم أو ال؟‬ ‫هل يحتوي الجهاز‪/‬املستلزم على‪:‬‬ ‫مادة مشعة‬ ‫مادة كيميائية خاضعة لرقابة وزارة الداخلية‬ ‫مادة مخدرة‬ ‫د) الغرض من االستيراد ومنفذ الدخول‬ ‫الغرض من االستخدام‪/‬االستيراد‬ ‫منفذ الدخول الجمركي‬ ‫‪Page 25 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫ه) اإلقرار والتعهد‪:‬‬ ‫نتعهد نحن املدونة بياناتنا أعاله باآلتي‪:‬‬ ‫تعهدات عامة‪:‬‬ ‫األنظمة واللوائح‬ ‫‪ )1‬مطابقة بنود اإلرسالية (الشحنة) الواردة في الفاتورة مع الشروط واملعايير الدولية واملتطلبات الواردة في "نظام األجهزة‬ ‫واملستلزمات الطبية" والئحته التنفيذية‪.‬‬ ‫‪ )2‬االلتزام بـ "نظام األجهزة واملستلزمات الطبية" والئحته التنفيذية واملتطلبات ذات العالقة‬ ‫‪ )3‬جميع البيانات املدخلة في الطلب في نظام غد االلكتروني صحيحة وعلى مسؤولية مقدم الطلب‪.‬‬ ‫‪ )4‬جميع املستندات املرفقة في الطلب متعلقة بالبنود املطلوبة‪.‬‬ ‫املواد الكيميائية‬ ‫‪ )5‬أن األجهزة واملستلزمات الطبية ذات العالقة ال تحتوي على أي مادة كيميائية من املواد املوضحة في الجداول امللحقة‬ ‫ً‬ ‫في اتفاقية حظر األسلحة الكيميائية وال تحتوي في تركيبها أيا من تلك املواد‪.‬‬ ‫‪ )6‬أن األجهزة واملستلزمات الطبية ذات العالقة ال تحتوي على أي مواد مخدرة أو متفجرة أو مشعة أو أي مواد محظورة‬ ‫غير املوضحة أعاله‪.‬‬ ‫‪ )7‬إبالغ وزارة الداخلية قبل نقل املواد الكيميائية الخطرة‪.‬‬ ‫ً‬ ‫‪ )8‬االحتفاظ باملستندات وسجالت بيانات الكميات الواردة واملنصرفة واملستهلكة سنويا‪.‬‬ ‫النقل والتخزين‬ ‫‪ )9‬مراعاة شروط النقل والتخزين حسب اشتراطات ومتطلبات املصنع والهيئة العامة للغذاء والدواء والجهات الحكومية‬ ‫األخرى ذات العالقة مع إيضاح مكان التخزين بعد فسح اإلرسالية (الشحنة)‪.‬‬ ‫‪ )10‬سحب األجهزة واملستلزمات الطبية من الجمارك لحظة وصولها دون أي تأخير كما نتحمل أي مسئولية تترتب على‬ ‫هذا التأخير‪.‬‬ ‫اإلجراءات الجمركية‬ ‫‪ )11‬إحضار أصل الفاتورة وشهادة املنشأ لدى منفذ الوصول‪.‬‬ ‫العاملين‬ ‫ً‬ ‫ً‬ ‫‪ )12‬األفراد القائمين بالعمل مؤهلون علميا وعمليا‬ ‫املشكالت والحوادث‬ ‫‪ )13‬ابالغ املركز الوطني لبالغات األجهزة واملستلزمات الطبية (‪ )NCMDR‬بالهيئة عن أي حوادث أو مشكالت ذات عالقة‬ ‫بالجهاز‪/‬املستلزم الطبي ذو العالقة‪.‬‬ ‫‪Page 26 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫ّ‬ ‫املصنع و‪/‬أو املمثل املعتمد في أنشطة الرقابة بعد التسويق وتشمل التحقيق في البالغات‬ ‫‪ )14‬التعاون مع الهيئة و‪/‬أو‬ ‫ومتابعة اإلجراءات التصحيحية على الجهاز‪/‬املستلزم الطبي ذو العالقة‪.‬‬ ‫الدعاية واإلعالن‬ ‫ً‬ ‫‪ )15‬عدم إصدار أي مادة دعائية أو إعالنية للجهاز أو املستلزم الطبي ذو العالقة إال إذا كان حاصال على اإلذن بالتسويق‬ ‫لألجهزة واملستلزمات الطبية‪.‬‬ ‫االستخدام‬ ‫‪ )16‬أال تستخدم األجهزة واملستلزمات الطبية ذات العالقة إال في األغراض املوردة من أجلها فقط‪ ،‬وعدم تداولها في غير‬ ‫األماكن املخصصة لذلك‪ ،‬وتحمل جميع األضرار الناجمة عن سوء االستخدام أو استخدامها في غير الغرض الذي‬ ‫وردت من أجله‪.‬‬ ‫تعهدات إضافية‪:‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لألجهزة واملستلزمات الطبية املستعملة‬ ‫عدم تداول األجهزة واملستلزمات الطبية ذات العالقة باململكة حتى بعد صيانتها أو تجديدها‪ ،‬وإعادة تصديرها بعد‬ ‫صيانتها أو تجديدها وإخطار الهيئة عند تصديرها مع إحضار ما يثبت ذلك‪ ،‬مالحظة‪ :‬ال ينطبق ذلك عند الرغبة‬ ‫بتداول الجهاز‪/‬املستلزم الطبي املجدد‪ ،‬بشرط االلتزام باملادتين (‪ )3/20‬و(‪ )4/20‬من "الالئحة التنفيذية لنظام األجهزة‬ ‫واملستلزمات الطبية"‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لغرض العرض‬ ‫ً‬ ‫‪ )17‬عدم إصدار أي مادة دعائية أو إعالنية للجهاز أو املستلزم الطبي ذو العالقة إال إذا كان حاصال على اإلذن بالتسويق‬ ‫لألجهزة واملستلزمات الطبية‪ ،‬ويمكن تقديم بعض التفاصيل عنها للمختصين فقط‬ ‫‪ )18‬أال يستخدم الجهاز‪ /‬املستلزم إال بعد وجود بطاقة تعريفية (ملصق خارجي) على الجهاز‪/‬املستلزم الطبي (أو أحد‬ ‫حاوياته أو أغلفته إن تعذر ذلك) ذو العالقة‪ ،‬باللغة العربية و‪/‬أو اإلنجليزية‪ ،‬تتضمن أن الجهاز‪/‬املستلزم الطبي‬ ‫مخصص للعرض فقط وليس للبيع‪.‬‬ ‫‪ )19‬إعادة تصدير األجهزة واملستلزمات الطبية ذات العالقة بتاريخ ‪( .................................‬ستة أشهر كحد أقص ى) أو إتالفها‬ ‫(وفقا ملتطلبات اإلتالف املشار إليها في "متطلبات رقابة ما بعد التسويق لألجهزة واملستلزمات الطبية (‪MDS-‬‬ ‫‪ )")REQ11‬مع تقديم ما يثبت ذلك للهيئة‪ ،‬وعندما ال يمكن تطبيق ذلك فيجب تقديم مسوغ مقبول لدى الهيئة‪.‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لغرض الدراسات السريرية‬ ‫‪ )20‬أال يستخدم الجهاز‪ /‬املستلزم إال بعد وجود بطاقة تعريفية (ملصق خارجي) على الجهاز‪/‬املستلزم الطبي (أو أحد‬ ‫حاوياته أو أغلفته إن تعذر ذلك) ذو العالقة‪ ،‬باللغة العربية و‪/‬أو اإلنجليزية‪ ،‬تتضمن أن الجهاز‪/‬املستلزم الطبي‬ ‫مخصص للدراسات السريرية فقط‪.‬‬ ‫‪Page 27 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫‪ )21‬إعادة تصدير األجهزة واملستلزمات الطبية ذات العالقة بعدما ينتفي الغرض الذي جلب من أجلها أو إتالفها (وفقا‬ ‫ملتطلبات اإلتالف املشار إليها في "متطلبات رقابة ما بعد التسويق لألجهزة واملستلزمات الطبية (‪)")MDS-REQ11‬‬ ‫مع تقديم ما يثبت ذلك للهيئة‪ ،‬وعندما ال يمكن تطبيق ذلك فيجب تقديم مسوغ مقبول لدى الهيئة‪.‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لغرض التعليم أو األبحاث غير السريرية‬ ‫‪ )22‬أال يستخدم الجهاز‪/‬املستلزم إال بعد وجود بطاقة تعريفية (ملصق خارجي) على الجهاز‪/‬املستلزم الطبي (أو أحد‬ ‫حاوياته أو أغلفته إن تعذر ذلك) ذو العالقة‪ ،‬باللغة العربية و‪/‬أو اإلنجليزية‪ ،‬تتضمن أن الجهاز‪/‬املستلزم الطبي‬ ‫مخصص للتعليم أو األبحاث غير السريرية فقط‪.‬‬ ‫‪ )23‬إعادة تصدير األجهزة واملستلزمات الطبية ذات العالقة بعدما ينتفي الغرض الذي جلب من أجلها أو إتالفها (وفقا‬ ‫ملتطلبات اإلتالف املشار إليها في "متطلبات رقابة ما بعد التسويق لألجهزة واملستلزمات الطبية (‪)")MDS-REQ11‬‬ ‫مع تقديم ما يثبت ذلك للهيئة‪ ،‬وعندما ال يمكن تطبيق ذلك فيجب تقديم مسوغ مقبول لدى الهيئة‪.‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لألجهزة واملستلزمات الطبية لغرض إنساني (وتشمل األجهزة الطبية املصنعة‬ ‫حسب الطلب)‬ ‫‪ )24‬أال يستخدم الجهاز‪ /‬املستلزم إال بعد وجود بطاقة تعريفية (ملصق خارجي) على الجهاز‪/‬املستلزم الطبي (أو أحد‬ ‫حاوياته أو أغلفته إن تعذر ذلك) ذو العالقة‪ ،‬باللغة العربية و‪/‬أو اإلنجليزية‪ ،‬تتضمن أن الجهاز‪/‬املستلزم الطبي مصنع‬ ‫حسب الطلب‪ ،‬وذلك في حال استيراد األجهزة الطبية املصنعة حسب الطلب‪.‬‬ ‫‪ )25‬إعادة تصدير األجهزة واملستلزمات الطبية ذات العالقة بعدما ينتفي الغرض الذي جلب من أجلها أو إتالفها (وفقا‬ ‫ملتطلبات اإلتالف املشار إليها في "متطلبات رقابة ما بعد التسويق لألجهزة واملستلزمات الطبية (‪)")MDS-REQ11‬‬ ‫مع تقديم ما يثبت ذلك للهيئة‪ ،‬وعندما ال يمكن تطبيق ذلك فيجب تقديم مسوغ مقبول لدى الهيئة‪.‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لغرض التصنيع املحلي‬ ‫‪ )26‬أن تتوافق الكمية املستوردة مع مخرجات اإلنتاج‪.‬‬ ‫‪ )27‬أن يتم حصول األجهزة واملستلزمات الطبية ذات العالقة على اإلذن بالتسويق بعد تصنيعها (انظر ‪.)MDS-REQ1‬‬ ‫تعهدات إضافية متعلقة باإلذن باالستيراد لألجهزة واملستلزمات الطبية املستعملة املراد استيرادها لغرض صيانتها‬ ‫باململكة ثم إعادة تصديرها‬ ‫‪ )28‬أن تتم الصيانة في منشأة حاصلة على رخصة صيانة لألجهزة واملستلزمات الطبية‪.‬‬ ‫‪ )1‬التوقيع‬ ‫اسم الشخص املســؤول‬ ‫املسمى الوظيف ـ ـ ـ ـ ـي‬ ‫التاريـــــــــــــــــــــــخ‬ ‫‪Page 28 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫التوقي ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـع‬ ‫الختم‬ ‫‪Page 29 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫‪Annex (3): Declaration and Attestation of Health Practitioner‬‬ ‫‪Click here for printable and editable version‬‬ ‫‪Medical Device‬‬ ‫الجهاز واملستلزم الطبي‬ ‫الكمية‬ ‫الغرض من االستخدام‬ ‫املوديل‬ ‫اسم الجهاز‪/‬املستلزم الطبي‬ ‫م‬ ‫‪Qty‬‬ ‫‪Intended Use‬‬ ‫‪Model‬‬ ‫‪Medical Device Name‬‬ ‫‪1‬‬ ‫‪2‬‬ ‫‪3‬‬ ‫‪Justifications:‬‬ ‫مبررات الطلب‪:‬‬ ‫‪ 1‬أذكر التشخيص أو العالج أو الوقاية الذي تم من‬ ‫أجله طلب هذا الجهاز‪/‬املستلزم‬ ‫‪Provide the diagnosis, treatment or‬‬ ‫‪prevention for which the device is required‬‬ ‫‪ 2‬اذكر أسباب اختيار هذا الجهاز‪/‬املستلزم غير املسجل‬ ‫على الجهاز‪/‬املستلزم املسجل باململكة أو العالجات‬ ‫التقليدية لهذا املريض املحدد‬ ‫‪Provide the reasons why this unregistered‬‬ ‫‪device was chosen over a registered device‬‬ ‫‪within the KSA or conventional therapies‬‬ ‫‪for this particular patient‬‬ ‫‪ 3‬وضح وعدد املخاطر والفوائد املرتبطة باستخدام هذا‬ ‫الجهاز‪/‬املستلزم ووضح كيف أن فوائده املرجوة‬ ‫ستفوق مخاطره‬ ‫‪Identify and list the risks and benefits‬‬ ‫‪associated with the use of the device and‬‬ ‫‪indicate how the benefits obtained would‬‬ ‫‪outweigh the risks‬‬ ‫‪ 4‬قارن مخاطر هذا الجهاز‪/‬املستلزم غير املسجل‬ ‫باململكة بالعالجات التقليدية‬ ‫‪Compare the risks of the unregistered‬‬ ‫‪device within the KSA with conventional‬‬ ‫‪therapies‬‬ ‫‪Declaration:‬‬ ‫اإلقرار‪:‬‬ ‫أقر باآلتي‪:‬‬ ‫‪ )1‬إني على دراية كاملة باملخاطر الصحية للجهاز أو املستلزم الطبي املطلوب وفوائده مقارنة بالعالجات التقليدية أو‬ ‫األجهزة البديلة املتوفرة في السوق‪.‬‬ ‫‪ )2‬أن لدي إملام باملعلومات املتاحة عن سالمة وأداء الجهاز‪/‬املستلزم الطبي املطلوب‪.‬‬ ‫‪ )3‬ابالغ املركز الوطني لبالغات األجهزة واملستلزمات الطبية (‪ )NCMDR‬بالهيئة عن أي حوادث أو مشكالت ذات عالقة‬ ‫بالجهاز‪/‬املستلزم الطبي‪.‬‬ ‫‪ )4‬عدم إعادة استخدام األجهزة واملستلزمات الطبية على مريض أخر غير الذي جلبت من أجله‪ ،‬وإعادة تصديرها بعدما‬ ‫ينتفي الغرض الذي جلب من أجلها أو إتالفها مع تقديم ما يثبت ذلك للهيئة‪ ،‬وعندما ال يمكن تطبيق ذلك فيجب‬ ‫تقديم مسوغ مقبول لدى الهيئة‪.‬‬ ‫‪Page 30 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

ّ ‫أو املوزع في أنشطة الرقابة بعد التسويق وتشمل‬/‫أو املستورد و‬/‫أو املمثل املعتمد و‬/‫املصنع و‬ ‫أو‬/‫) التعاون مع الهيئة و‬5 .‫املستلزم الطبي‬/‫التحقيق في البالغات ومتابعة اإلجراءات التصحيحية على الجهاز‬ :‫أو ذويه‬/‫) أن اآلتي تم شرحه أو سيتم شرحه للمريض و‬6 ‫ أن الهيئة العامة للغذاء والدواء ال تضمن سالمة وكفاءة وجودة األجهزة واملستلزمات الطبية املذكورة أعاله‬− ‫ وأن هذه األجهزة واملستلزمات غير مسجلة في اململكة ولكن قد يوافق‬،‫وأدائها للغرض الذي صنعت من أجله‬ .‫عليها تحت تدابير خاصة‬ .‫ إيضاح املخاطر املحتملة الستخدام األجهزة واملستلزمات الطبية املذكورة أعاله والفوائد املرجوة منها‬− I declare with the following: 1) I am fully aware of the health-related risks and benefits of the requested medical device in comparison to conventional therapies or alternative devices available on the market. 2) I have knowledgeable about the available safety and performance information in respect of the requested device. 3) I will report to the SFDA’s National Centre for Medical Device Reporting (NCMDR), any relevant adverse event of which it becomes aware, that involves the medical device(s). 4) Not to reuse the device on a patient other than the one for whom the device were imported, and re- export or destroy it immediately upon completion of its use, providing the SFDA a proof. If this cannot be applied, a justification acceptable to the SFDA shall be submitted. 5) I will cooperate with the SFDA, manufacturer, authorized representative, importer and/or distributer on post market surveillance activities. 6) I have explained or I will explain the following to the patient and/or the patient's family: − that the Saudi Food & Drug Authority (SFDA) can give no guarantee as to the safety, effectiveness, or quality of the above device(s), and that device(s) is not registered for use in the KSA but that use of the device may be authorized under special provisions. − the possible risks and benefits of the above device(s). :‫رقم هوية املريض‬ Patient’s ID: :‫اسم املمارس الصحي‬ Healthcare Professional’s Name: :‫جهة عمل املمارس الصحي‬ Healthcare Professional’s Organization : :‫توقيع املمارس الصحي‬ Healthcare Professional’s Signature: :‫التاريخ‬ Date: Page 31 of 44 MDS-REQ-005-V5/230719

‫‪Annex (4): Declaration and Attestation of Beneficiaries of Research‬‬ ‫‪Products‬‬ ‫‪Click here for printable and editable version‬‬ ‫]‪[To be printed on Beneficiary Letterhead‬‬ ‫(يطبع على الورق الرسمي الخاص باملستفيد)‬ ‫اضغط هنا لنسخة قابلة للطباعة والتعديل‬ ‫التاريخ‪............... :‬‬ ‫املحترم‬ ‫سعادة ‪ /‬نائب الرئيس التنفيذي لقطاع العمليات‬ ‫ً‬ ‫بناء على التعميد رقم ‪ .................................‬والصادر بتاريخ ‪ ..........................................‬لصالح شركة ‪..................................‬‬ ‫واملتعلق بتوريد أجهزة ومستلزمات طبية لالستخدام البحثي أو التعليمي أدناه داخل املنشأة املعنية‬ ‫الشركة املصنعة‬ ‫الكمية‬ ‫اسم الجهاز‪/‬املستلزم‬ ‫م‬ ‫‪1‬‬ ‫‪2‬‬ ‫‪3‬‬ ‫‪...‬‬ ‫نتعهد بعدم استخدام األجهزة واملستلزمات املذكورة أعاله في التطبيقات الطبية العالجية أو التشخيصية وإنما يقتصر‬ ‫استعمالها على املجال البحثي أو التعليمي فقط‪ ،‬بغض النظر عن كفاءتها لالستخدامات العالجية أو التشخيصية‪.‬‬ ‫ولكم جزيل الشكر والتقدير ‪،،،،‬‬ ‫التوقيع‬ ‫اسم الشخص املســؤول‬ ‫املسمى الوظيف ـ ـ ـ ـ ـي‬ ‫التاريـــــــــــــــــــــــخ‬ ‫التوقي ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـع‬ ‫الختم‬ ‫‪Page 32 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

‫‪Annex (5): Declaration and Attestation for Healthcare Provider for‬‬ ‫‪Importing in National Emergency‬‬ ‫‪Click here for printable and editable version‬‬ ‫]‪[To be printed on Healthcare Provider Letterhead‬‬ ‫اضغط هنا لنسخة قابلة للطباعة والتعديل‬ ‫يطبع على الورق الرسمي الخاص بمقدم الرعاية الصحية‬ ‫بالرجوع الى التعميد رقم ‪ ...........................................‬والصادر بتاريخ ‪ ........................................‬لصالح شركة‬ ‫‪ ......................................................‬نرغب باستيراد اآلتي لغرض خاص وطارئ ملنشأتنا فقط‪:‬‬ ‫الكمية‬ ‫املسوغات*‬ ‫اسم املصنع‬ ‫اسم الجهاز‪/‬املستلزم الطبي‬ ‫م‬ ‫‪1‬‬ ‫‪2‬‬ ‫‪3‬‬ ‫* يجب ذكر املسوغات التي توضح بأن االستيراد طارئ‪ .‬في حال استيراد أجهزة أو مستلزمات طبية غير حاصلة على اإلذن بالتسويق‪ ،‬يجب ذكر مسوغات عدم تأمينه من البديل‬ ‫الحاصل على اإلذن بالتسويق‪ .‬وفي حال أن املستورد غير حاصل على رخصة مستورد لألجهزة واملستلزمات الطبية‪ ،‬يجب ذكر مسوغات ذلك‪.‬‬ ‫نقر نحن ‪ ....................................................................................................................‬أننا على علم بأن الهيئة العامة للغذاء‬ ‫والدواء ال تضمن سالمة وكفاءة وجودة األجهزة واملستلزمات الطبية املذكورة أعاله وأدائها للغرض الذي صنعت من أجله‪.‬‬ ‫وسيكون استيرادها تحت مسئوليتنا‪ ،‬ونتعهد بأنها لن تستخدم إال في منشأتنا فقط ولن نقوم باستخدامها في أي مكان أخر‬ ‫أو إعارتها إال بموافقة الهيئة‪ .‬ونتعهد بإبالغ املركز الوطني لبالغات األجهزة واملستلزمات الطبية بالهيئة العامة للغذاء والدواء‬ ‫عن أي إشعار إنذار السالمة أو استدعاءات أو أي أحداث سلبية ذات عالقة باألجهزة واملستلزمات الطبية املذكورة اعاله‬ ‫سواء وقعت داخل اململكة‪ ،‬أو وقعت خارجها ولها عواقب على األجهزة واملستلزمات الطبية في اململكة‪ ،‬وذلك‬ ‫ً‬ ‫فور العلم بها‬ ‫عبر الرابط التالي‪.(http://ncmdr.sfda.gov.sa) :‬‬ ‫ولكم جزيل الشكر والتقدير‪،،،،‬‬ ‫التوقيع‬ ‫اسم الشخص املســؤول‬ ‫املسمى الوظيف ـ ـ ـ ـ ـي‬ ‫التاريـــــــــــــــــــــــخ‬ ‫التوقي ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـع‬ ‫الختم‬ ‫‪Page 33 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

Annex (6): Application Form of Free Sale Certificate Click here for printable and editable version [To be printed on Letterhead] General Information ‫معلومات عامة‬ Invoice No.: :‫رقم الفاتورة‬ Customs Ports: :‫املنفذ الجمركي‬ Destination Country: :‫الدولة املصدر لها‬ Establishment Information ‫معلومات املنشأة‬ Establishment Name (in Arabic): :)‫اسم املنشأة (باللغة العربية‬ Commercial Registration No.: :‫رقم السجل التجاري‬ Establishment Account of GHAD system "‫حساب املنشأة في "نظام غد‬/‫رقم املعرف‬ National Address: :‫العنوان الوطني‬ Page 34 of 44 MDS-REQ-005-V5/230719

‫‪Medical Devices Information‬‬ ‫معلومات األجهزة واملستلزمات الطبية‬ ‫الوحدة‬ ‫الكمية‬ ‫رقم القيد الوطني للجهاز التعرفة الجمركة‬ ‫الرقم التسلسلي‪/‬‬ ‫طراز‬ ‫االسم التجاري للجهاز أو‬ ‫أو املستلزم الطبي‬ ‫التشغيلة‪ /‬املجموعة‬ ‫الجهاز أو املستلزم الطبي‬ ‫املستلزم الطبي‬ ‫عندما ينطبق ذلك‬ ‫فقط لألجهزة واملستلزمات التي‬ ‫ستعاد إلى اململكة‬ ‫‪Unit‬‬ ‫‪Qty.‬‬ ‫‪HS Code‬‬ ‫‪Medical Device‬‬ ‫‪Serial/Batch‬‬ ‫‪Medical Device‬‬ ‫‪Medical Device‬‬ ‫‪National Listing‬‬ ‫‪Number‬‬ ‫‪Model Number‬‬ ‫‪Brand Name‬‬ ‫‪Number‬‬ ‫‪if applicable‬‬ ‫‪Only for devices that‬‬ ‫‪will return to KSA‬‬ ‫‪1‬‬ ‫‪2‬‬ ‫‪3‬‬ ‫‪4‬‬ ‫‪5‬‬ ‫‪6‬‬ ‫‪7‬‬ ‫‪8‬‬ ‫‪..‬‬ ‫‪Attestations‬‬ ‫التعهدات‬ ‫‪−‬‬ ‫‪I confirm that the information given in this form is true,‬‬ ‫‪ −‬أتعهد بأن جميع البيانات املقدمة بهذا النموذج صحيحة‪.‬‬ ‫‪complete and accurate.‬‬ ‫‪ −‬أتعهد بإبالغ الهيئة بأي تغيير في املعلومات املقدمة في غضون (‪ )10‬أيام من حدوث‬ ‫التغيير‪.‬‬ ‫‪Page 35 of 44‬‬ ‫‪MDS-REQ-005-V5/230719‬‬

− I certify that I will inform the SFDA of any change in the submitted information, within (10) calendar days of the change ‫ وإذا‬،‫ أتعهد بأن جميع الوثائق املرفقة واملختومة بختم املنشأة هي نسخ طبق األصل‬− occurring. ‫ظهر خالف ذلك فإني أقر بارتكاب التزوير في الوثائق وأتحمل ما يترتب على ذلك من‬ − I certify that all attached documents are stamped by company's .‫الجزاء النظامي‬ stamp and considered as an official copy. I take the extreme responsibility for any forgery or incorrect information on these ‫ أتعهد بااللتزام بمقتض ي "نظام األجهزة واملستلزمات الطبية" والئحته التنفيذية‬− documents. ‫واملتطلبات والتعاميم والقرارات ذات العالقة‬ − I certify to comply with the “Law of Medical Devices” and its executive regulations, and relevant requirements, circulars and decisions. ‫ أتعهد باالحتفاظ بالوثائق والسجالت ذات العالقة وسجالت مخرجات خطوط اإلنتاج‬− − I certify to keep the relevant documents, records, and records of .‫وتقديمها للهيئة عند طلبها‬ production lines outcomes and provide them to the SFDA upon request. Signature ‫التوقيع‬ Name of authorized person: :‫اسم الشخص املفوض‬ National ID: :‫رقم الهوية الوطنية‬ Mobile No.: :‫رقم الجوال‬ Signature: :‫التوقيع‬ Establishment Stamp: :‫ختم املنشأة‬ Page 36 of 44 MDS-REQ-005-V5/230719

Annex (7): Medical Devices Shipments Procedures Prohibited Medical The following products are prohibited from importation: Devices A. Used medical devices, unless where the purpose of importing them is:  Maintaining or renewing them within the KSA and then re-exporting them.  Return them to the KSA after they have been maintained, calibrated, displayed as marketing samples, corrected according to a field safety notice (FSN) that requires it, or tested outside the KSA. B. Surgical gloves containing powder, patient examination gloves containing powder, and absorbable powder used to facilitate the wearing of medical gloves. C. Products bearing phrases indicating that they are intended for other than the KSA (e.g., For sale only in US) D. Following electrical medical devices: − intended to be operated to an a.c. power supply other than (230) or (400) volts, − intended to be operated with frequency other than (60) hertz, or − fitted with a/c power connector not compatible with part 401 of SBC or the Saudi standard entitled "Plugs and socket-outlets for household and similar purposes- safety requirements and test methods 250 V/13 A (SASO-2203)". E. Any medical device appears to the SFDA that may endanger the health or safety of patients and users, even if it has a MDMA from the SFDA. Storage, A. Storage and Transportation of Product: Transportation, Manufacturer’s instructions for the storage, handling, and transport Product of products they import shall be complied, and when transportation Shelf Life and or storage requires specific temperatures or humidity, an electronic Labeling data logger (sensor/reader/indicator) for temperature and humidity shall be available in each parcel for each shipment, and:  the data logger shall be activated from the time of shipment.  the data logger shall be readable, in detail without the need for a program to run it, at the POE. Page 37 of 44 MDS-REQ-005-V5/230719

 the serial number of the data logger shall be indicated in any of shipment documents (such as an invoice or bill of lading). B. Product Shelf Life: If the shelf life of the product is:  less than (1) year, the remaining shelf life, at the POE, shall not be less than 40%.  more than (1) year, the remaining shelf life, at the POE, shall not be less than (7) months. C. Labeling: Labeling of imported products shall be complied with the requirements of SFDA and correspond to the labeling previously submitted to the SFDA, if applicable. Samples SFDA withdraws random samples of imported shipments at POEs in Withdrawal order of assessment or examination according to risk-based studies and for testing and scientific evaluation purposes or suspension cases (e.g. misleading medical claims, sterilization and labeling malfunctioning, inappropriate environment conditions, or counterfeit… etc.). However, SFDA bear neither any costs of those samples nor costs of their testing in labs. Relevant POEs 1. King Khaled International Airport – Riyadh (RAP) 2. Riyadh Dry Port (RDP) 3. King Abdulaziz International Airport – Jeddah (JAP) 4. Jeddah Islamic Seaport – (JSP) 5. King Abdullah Seaport – Rabigh (RSP) 6. King Fahd International Airport – Dammam (DAP) 7. King Abdulaziz Seaport – Dammam (DSP) 8. King Fahd Causeway – Khobar (DBP) 9. Batha Port - Al Ahsa (BBP) 10. Haditha Port - Al Qurayyat (HBP). Document The originals of documents submitted to the SFDA shall be kept for five Retention years from the date of shipment clearance, and shall be submitted to the SFDA when requested. Approval Procedure The SFDA takes one of the following actions:  Release of the shipment, when the requirements are met.  Conditional release of the shipment and notify the importer of the notes to be corrected.  Rejection of the shipment, and the importer has the right to object within (60) days from the date of shipment rejection by Page 38 of 44 MDS-REQ-005-V5/230719

submitting an objection letter according to the "objection procedure to the refusal of releasing the shipment" published on the SFDA website. Page 39 of 44 MDS-REQ-005-V5/230719

Annex (8): Declaration of Conformity for the Shipment to Medical Devices Law and its Executive Regulation Click here for printable and editable version [To be printed Manufacturer on Letterhead] Manufacturer Name: ……………………………………..……………...………………………… Manufacturer Identification Number Assigned by the SFDA: …………………………………….. Manufacturer Address: ……………………………………..………………………………….….. Invoice Number (optional): ……………………………………..………………………………… I hereby declare that the medical device(s) identified below complies with the Medical Devices Law and its Executive Regulation and has been authorized by the SFDA to be placed on the KSA market. Authorized Representative Name: ………………………………….…………………………....... (Note: Not applicable for low-risk medical devices that are non-sterile and not having measuring function) Importer Name: ……………………………………………………………………………………. # Medical Device Quantity Serial Number/ Medical Device Listing National Trade Name1 Batch Number Registry Number (mentioned on the MDMA certificate) 1 2 … 1 Medical device trade name shall match the names mentioned in the invoice and the “SFDA E-Services (Ghad)”. Note: Additional devices may be attached as a list. Authorised Signatory (on behalf of the manufacturer) Name: Position: Email: Date: Signature: Page 40 of 44 MDS-REQ-005-V5/230719

Annex (9): Definitions & Abbreviations KSA Kingdom of Saudi Arabia SFDA Saudi Food and Drug Authority MDS Medical Devices Sector MOI Ministry of Interior POE Port of Entry Law Medical Devices Law issued by the Royal Decree No. (M/54) dated 6/7/1442 H. Implementing Implementing Regulation of Medical Devices Law issued by Saudi Regulation Food and Drug Authority Board of Directors decree No. (3-29-1443) dated 19/2/1443H. Authorized A legal person based in the Kingdom who has written authorization Representative (AR) from a manufacturer located outside the Kingdom to represent it in the Kingdom with regard to the implementation of this Law and its Regulations. Medical Device Any instrument, apparatus, implement, implant device, in vitro reagent or calibrator, software, or material used for operating medical devices, or any other similar or related article, intended to be used alone or in combination with other devices for diagnosis, prevention, monitoring, controlling, treatment, or alleviation of disease or injury, or for compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; controlling or assisting conception; sterilization of medical devices; providing information for medical or personal purposes by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. Medical Supply A medical substance or product used in diagnosis, treatment, prosthetics, or orthotics; or in disability cases or other medical uses for humans, including medical gases. Accessories of Medical Any substance or product intended specifically to be used with a Devices medical device to enable it to achieve its purpose. Home-Use Medical A medical device intended for use in any environment outside a Device healthcare facility. Lay Person (Non- A person who does not have formal education or training in a relevant Professional User) field of healthcare or medical discipline. Page 41 of 44 MDS-REQ-005-V5/230719

Custom-Made Medical a medical device that, at least, meets the following requirements: Device 1. Intended to a particular person (a patient or a healthcare professional); 2. Manufactured in accordance to a written request by an authorized professional specialist who, under his responsibility, gives specific design characteristics; and 3. It is intended to address the anatomo-physiological characteristics or pathological condition of the person for whom it is intended. Patient-Specific a medical device produced based on a specified design envelope of the Medical Device device (e.g., minimum and maximum dimensions, mechanical performance limits, and other relevant factors) that matched to a patient’s anatomy using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging. It is typically produced in through a process that is capable of being validated. It is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional. Adaptable Medical A medical device that is mass-produced and adapted, adjusted, Device assembled or shaped at the point of care, in accordance with the manufacturer’s validated instructions, to suit an individual patient’s specific anatomo-physiologic features prior to use. Free Sale Certificate A document issued by the SFDA stating that a manufacturer is registered in the Kingdom and that the medical devices to be exported have obtained marketing authorization. MDMA Medical Devices Marketing Authorization Identifying Information Any statement, information, or illustration printed on a medical (Labelling) device, including identifying information, technical description, method of use, and manner of storage and transportation. Circulation of Medical The provision of medical devices at no cost or for a fee, whether for Devices distribution or use. Page 42 of 44 MDS-REQ-005-V5/230719

Annex (10): List of Changes on the Previous Version Number & Date Changes Description of the Previous Version 1.0 − Changing in the text of sections (6), (7) and (8) of "Requirements". 17/9/2017 − Changing in the text of section (3) of "Required Documents". − Adding sections (4) and (5) to "Notes" of "Required Documents". − Changing in Annex (1). 2.0 − Changing in the text of section (7) of “Requirements”. 6/2/2018 3.0 − Changing in the text of sections “Product Shelf Life” 26/7/2018 − Reformatting some sections 4.0 − Genertal changing in the text of sections “Introduction” and Annex 20/10/2020 (1) for complying with Medical Devices Law and its regulation − Changing from “Guidance on Requirements of Shipments Clearance at Ports of Entry (MDS-G21) to “Requirements for Shipments Clearance Medical Devices and Other Relevant Products (MDS-REQ5)” − Changing on points (3-A) and (3-B) − Adding Annex (2) 5.0 − Combing the following documents with amendments to comply 23/3/2022 with the the “Law of Medical Devices” and its Executive Regulations: 1. Requirements for Shipments Clearance of Medical Devices at Ports of Entries (MDS-REQ5), v5 dated 23/3/2022 (Update). 2. Guidance for Medical Device Importers and Distributors, v2 dated 26/11/2011. 3. Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purposes Only (MDS-G8), v3 dated 27/12/2020. 4. Relevant requirements of “Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications (MDS-G12)”, v2 dated 23/5/2018. Page 43 of 44 MDS-REQ-005-V5/230719

5. Guidance on Importation Requirements of Medical Devices in National Emergency Situation (MDS- G14), v2 dated 28/7/2019. 6. Guidance on Importation Requirements for Personal Use and Custom-Made Medical Devices (MDS-G15), v1 dated 31/10/2016. 7. Relevant requirements of “Guidance on Importation Requirements for Medical Devices and Non-Medical IVDs Intended for Educational or Non-Clinical Research Purposes (MDS-G18)”, v2 dated 23/5/2018. 8. Guidance of Requirements for Preliminary Products Importation for the Purpose of Local Manufacturing of Medical Devices (MDS-G26), v1 dated 9/7/2018. 9. Requirements for Issuance of Saudi Free Sale Certificate (FAQ), dated 29/9/2015. 10. Requirements of Importation Permit for IVD Medical Devices, dated 26/9/2015. − Developing following requirements: 1. Requirements of Importation for Circulation of Medical Devices. 2. Requirements of Importation of Used Medical Devices. 3. Requirements of Importation for Humanitarian Purposes. 4. Requirements of Importation for Clinical Studies. Page 44 of 44 MDS-REQ-005-V5/230719