Bayan Taxonomy Explorer

Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

sfda_gov_sa · regulation · processed · 45 chunks

date_gregorian=2023-10-16 date_hijri=1440-06-12 document_type=regulation entity=language:en entity=format:application/pdf language=mixed taxonomy_l1=health taxonomy_l2=pharmaceuticals taxonomy_l3=medical_devices validity=valid validity_confidence=0.6

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 <table><tr><td>Importation for Circulation of Medical Devices</td><td>1</td><td>For importing medical devices for the circulation purpose, the following shall be obtained: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).</td></tr></table> Page 4 of 44 MDS-REQ-005-V5/230719 Importation of Used Medical Devices 2 Used medical devices shall not be imported unless the purpose of importing is one of the following: 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 <table><tr><td>Importation for Local Manufacturing</td><td>3</td><td>For importing semi-finished medical devices (and raw and non-raw chemicals) for the purpose of local 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).</td></tr></table> Page 6 of 44 MDS-REQ-005-V5/230719 <table><tr><td>Importation for Clinical Studies</td><td>4</td><td>For importing medical devices for pre-marketing clinical studies purpose, the following shall be obtained:1) Approval (No Objection Letter) for Conducting the Clinical Trial (SeeMDS-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).</td></tr></table> Page 7 of 44 MDS-REQ-005-V5/230719 Importation for Research and Education 5 For importing medical devices for non-clinical research and education purpose, the following shall be obtained: 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 Demonstration 6 For importing samples medical devices used in exhibitions, festivals 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 relevant 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 <table><tr><td>Importation for National Emergency</td><td>7</td><td>For importing medical devices in national emergency situations (e.g. natural disaster, war, or epidemics) for the own use of healthcare 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).</td></tr></table> Page 10 of 44 MDS-REQ-005-V5/230719 Importation for Humanitarian Purposes (including Custom-Made Medical Devices) 8 For importing medical devices for the humanitarian purpose, the following shall be obtained: 1) Importation License/Permission, according to: - Medical device intended to be imported shall be custom-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 <table><tr><td>Personal Importation</td><td>9</td><td>For importing medical devices for the personal use, the following 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 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.</td></tr><tr><td></td><td>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.</td></tr></table> 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 <table><tr><td>Free Sale Certificate</td><td>10</td><td>Manufacturer can, upon its request, obtain “Certificate of Free Sale” 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.</td></tr></table> Page 13 of 44 MDS-REQ-005-V5/230719 Required Documents <table><tr><td></td><td>Required Documents</td><td>Notes</td></tr><tr><td colspan="3">(1) Required Documents for License of Importing for Circulation</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Importer License</td><td>- It shall be valid, noting that it can be renewed 60 days before its expiration- For more information, see MDS-REQ9</td></tr><tr><td>6</td><td>Civil Defense License</td><td>- 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</td></tr><tr><td>7</td><td>Material Safety Data Sheet</td><td>- It shall be issued by the manufacturer</td></tr><tr><td>8</td><td>Chemical details in terms of weight or volume</td><td>- Required only if the product contains 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</td></tr></table> Page 14 of 44 MDS-REQ-005-V5/230719 <table><tr><td>9</td><td>Application and attestation forms required, for chemicals importation, by MOI that are specified in Article Two of “Regulation for Law of Chemicals Import and Management”</td><td>- Required only if the product contains chemical substances under MOI control- The attestation of responsible person for chemical warehouse shall contain his contact information- They shall contain storage warehouse location (Sketch)</td></tr><tr><td>10</td><td>Medical Devices Marketing Authorization (MDMA)</td><td>-</td></tr><tr><td>11</td><td>AR License</td><td>- 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</td></tr><tr><td colspan="3">(2) Required Documents for License of Importing Used Medical Devices</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>3</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td colspan="3">(3) Required Documents for License of Importing for Local Manufacturing</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td rowspan="2">2</td><td rowspan="2">Purchase Invoice</td><td>- If it is not available, provide the Pro Forma</td></tr><tr><td>- 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</td></tr><tr><td></td><td></td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr></table> Page 15 of 44 MDS-REQ-005-V5/230719 <table><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Manufacturer License</td><td>- 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</td></tr><tr><td>6</td><td>Evidence that the product is classified as a medical device</td><td>- Not required for importing raw and non-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</td></tr><tr><td>7</td><td>Material Safety Data Sheet</td><td>- It shall be issued by the manufacturer</td></tr><tr><td>8</td><td>Chemical details in terms of weight or volume</td><td>- Required only if the product contains 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</td></tr><tr><td>9</td><td>Application and attestation forms required, for chemicals importation, by MOI that are specified in Article Two of “Regulation for Law of Chemicals Import and Management”</td><td>- Required only if the product contains chemical substances under MOI control- The attestation of responsible person for chemical warehouse shall contain his contact information- They shall contain storage warehouse location (Sketch)</td></tr><tr><td colspan="3">(4) Required Documents for License of Importing for Clinical Studies</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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</td></tr></table> Page 16 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td></td><td>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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Importer License</td><td>- It shall be valid, noting that it can be renewed 60 days before its expiration- For more information, see MDS-REQ9</td></tr><tr><td>6</td><td>SFDA Approval (No Objection Letter) for Conducting the Clinical Trial</td><td>-</td></tr><tr><td colspan="3">(5) Required Documents for License of Importing for Research and Education</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Importer License or Manufacturer License</td><td>- The following are excluded:○ Healthcare providers○ Educational facilities○ Research centers○ Independent researchers</td></tr></table> Page 17 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td></td><td>- It shall be valid, noting that it can be renewed 60 days before its expiration- For more information, see MDS-REQ9</td></tr><tr><td>6</td><td>Declaration of Beneficiaries of Research Products</td><td>- See Annex (4)</td></tr><tr><td>7</td><td>Beneficiary PO</td><td>- Required only if there is no a label, fixed by the manufacturer, include that the device is for educational or research use only</td></tr><tr><td>8</td><td>Manufacturer letter clarifying the importation purpose</td><td>- Required only if the importer is a local 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</td></tr><tr><td colspan="3">(6) Required Documents for License of Importing for Demonstration</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Importer License</td><td>- The following are excluded:○ Facilities organizing exhibitions○ Healthcare providers○ Educational facilities○ Other relevant facilities</td></tr></table> Page 18 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td></td><td>- It shall be valid, noting that it can be renewed 60 days before its expiration- For more information, see MDS-REQ9</td></tr><tr><td>6</td><td>Label of the medical device indicates that it is for demonstration purposes only and not for sale</td><td>- It shall include a phrase indicating the use purpose of use, such as: (For Demo Only) and (Not for sale)</td></tr><tr><td>7</td><td>Labeling of medical device</td><td>- It includes:○ Label affixed to a medical device or any of its containers or wrappers○ Instructions for Use (IFU)</td></tr><tr><td>8</td><td>Evidence that the product is classified as a medical device</td><td>- Evidence may be a declaration of conformity (DOC), or a product classification decision issued by the SFDA, see services of products classification</td></tr></table> (7) Required Documents for License of Importing for National Emergency <table><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr><tr><td>5</td><td>Importer License</td><td>- 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</td></tr></table> Page 19 of 44 MDS-REQ-005-V5/230719 <table><tr><td>6</td><td>Declaration of Healthcare Provider</td><td>- See Annex (5)</td></tr><tr><td>7</td><td>Declaration of Conformity (DOC)</td><td>- 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</td></tr><tr><td>8</td><td>Material Safety Data Sheet</td><td>- It shall be issued by the manufacturer</td></tr><tr><td>9</td><td>Chemical details in terms of weight or volume</td><td>- Required only if the product contains 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</td></tr><tr><td>10</td><td>Application and attestation forms required, for chemicals importation, by MOI that are specified in Article Two of “Regulation for Law of Chemicals Import and Management”</td><td>- Required only if the product contains chemical substances under MOI control- The attestation of responsible person for chemical warehouse shall contain his contact information- They shall contain storage warehouse location (Sketch)</td></tr><tr><td colspan="3">(8) Required Documents for License of Importing for Custom-Made Medical Devices)</td></tr><tr><td>1</td><td>Declaration of Importers</td><td>- See Annex (2)- It shall be signed by authorized person identified in GHAD system</td></tr><tr><td>2</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>3</td><td>Bill Of Lading</td><td>- If any</td></tr><tr><td>4</td><td>Country of Origin Certificate</td><td>- If any</td></tr></table> Page 20 of 44 MDS-REQ-005-V5/230719 <table><tr><td>5</td><td>Declaration of Health Practitioner</td><td>- See Annex (3)</td></tr><tr><td>6</td><td>Healthcare professional's written prescription</td><td>- Required only for importing custom-made 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</td></tr><tr><td colspan="3">(9) Required Documents for Free Sale Certificate</td></tr><tr><td>1</td><td>Application Form of Free Sale Certificate</td><td>- See Annex (6)</td></tr><tr><td>2</td><td>Medical Devices Marketing Authorization (MDMA)</td><td>- Automatically verified without the need to provide it in the application- For more information, see MDS-REQ1</td></tr><tr><td>3</td><td>Manufacturer License</td><td>- For more information, see MDS-REQ9</td></tr><tr><td colspan="3">(10) Required Documents for Shipments Clearance</td></tr><tr><td>1</td><td>Purchase Invoice</td><td>- 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)</td></tr><tr><td>2</td><td>Bill Of Lading</td><td>- 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 off shipment documents (such as an invoice or bill of lading)</td></tr><tr><td>3</td><td>Customs Declaration</td><td>-</td></tr><tr><td>4</td><td>Medical Devices Marketing Authorization (MDMA)</td><td>- Required only for importing medical devices for the purpose of circulation</td></tr></table> Page 21 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td></td><td>- The MDMA shall be valid, noting that it can be renewed 90 days before its expiration- For more information, see MDS-REQ1</td></tr><tr><td>5</td><td>AR License</td><td>- 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</td></tr><tr><td>6</td><td>Importer License</td><td>- 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</td></tr><tr><td>7</td><td>Declaration of Conformity to Medical Devices Law and its Implementing Regulation</td><td>- Required only for importing medical devices for the purpose of circulation- See Annex (8)- This declaration is different than the declaration of conformity provided for purpose of obtaining MDMA</td></tr><tr><td>8</td><td>Importation License/Permission</td><td>- Not required for importing medical devices for the purpose of circulation and contain chemical substances</td></tr></table> Page 22 of 44 MDS-REQ-005-V5/230719 Annexes SFDA 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 <table><tr><td>Name of Device:</td><td>: اسم الجهاز/المستلزم الطي :</td></tr><tr><td>Quantity:</td><td>: الكميه:</td></tr><tr><td>Country of Shipment:</td><td>: بلد الشحن:</td></tr><tr><td>Carrier:</td><td>: الشركه الناقله:</td></tr><tr><td></td><td>: مسوغ الشرااء:</td></tr><tr><td>Justifications:</td><td></td></tr><tr><td></td><td></td></tr><tr><td>Purchase method:</td><td>: طريقه الشرااء:</td></tr><tr><td>○ Through Internet: Write the the name of the site ......</td><td>○ عبر الانترنت: اكتب اسم الموقع ......</td></tr><tr><td>○ Other: ......</td><td>○ اخري: ......</td></tr><tr><td></td><td></td></tr><tr><td>اتعجب بان الاجهزه والملستلمات الطبيه المذكوره في الطلب السستخدم الشخصي فقط وليست للاستخدم لاي غرض اخري. كما اقرباني علي علم ان الهييه العامه للغذاء والدواء لا تضمن سلامتها او كفاءتها او جودتها، لما اتحمل كامل المسؤوليه في حال نتج عن استخدامها اي مخاطر. كما اقربان جميع المعلومات المقدمه صحيحه.</td><td></td></tr><tr><td>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.</td><td></td></tr><tr><td>Name of User's Device:</td><td>اسم مستخدم الجهاز:</td></tr><tr><td>Mobile Number:</td><td>رقم الجوال:</td></tr><tr><td>ID/Passport No.:</td><td>رقم الهويه/الجواز:</td></tr><tr><td>E-mail:</td><td>البريد الالكتروني:</td></tr><tr><td>National Address:</td><td>العنوان الوطني:</td></tr><tr><td>Date:</td><td>التاريخ:</td></tr><tr><td>Signature</td><td>التوقيع:</td></tr></table> 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] <table><tr><td colspan="6">بيانات المنشاه (1)</td></tr><tr><td colspan="3"></td><td colspan="3">اسم الشركه/المؤسسه/المستودع/المستشفي</td></tr><tr><td colspan="3"></td><td colspan="3">رقم المعرف في نظام غد</td></tr><tr><td colspan="6">ب) بيانات الاجهزه والمستلزمات الطبيه (حسب بيانات الفاتوره)</td></tr><tr><td>بلد الصنع</td><td>الشركه المصنعه</td><td>تاريخ الفاتوره</td><td>الكميه</td><td>رقم الفاتوره</td><td>اسم البند</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td>3</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td>...</td></tr><tr><td colspan="6">ج) محتويات الجهاز والملتزم (عند الاجابه بنعم) اسم الماده</td></tr><tr><td colspan="3">نعم اولا?</td><td colspan="3">هل يحتوي الجهاز/المستلزم علي:</td></tr><tr><td colspan="3"></td><td colspan="3">ماده مشعه</td></tr><tr><td colspan="3"></td><td colspan="3">ماده كيمياييه خاضعه لرقابه وزاره الداخليه</td></tr><tr><td colspan="3"></td><td colspan="3">ماده مخدره</td></tr><tr><td colspan="6">د) الغرض من الاستيراد ومنفذ الدخول</td></tr><tr><td colspan="3"></td><td colspan="3">الغرض من الاستخدام/الاستيراد</td></tr><tr><td colspan="3"></td><td colspan="3">منفذ الدخول الجمركي</td></tr></table> Page 25 of 44 MDS-REQ-005-V5/230719 ه) الاقرار والتعهد: نتعهد نحن المدوله بياناتنا اعلاماتي: تعهدات عامه: الانظمه واللوايح 1) مطابقه بنود الارساليه (الشحنه) الوارده في الفاتوره مع الشروط والمعابير الدوليه والمطلبات الوارده في "نظام الاجنه والمستلزمات الطبيه " ولانحته التنفيذيه. (٢) الالتزام ب "نظام الاجهزه والمستلزمات الطبيه" ولانحته التنفيذيه والمتطلبات ذات العلاقه جميع البيانات المدخله في الطلب في نظام غد الالكتروني صحيحه وعلي مسؤوليه مقدم الطلب. (٤) جميع المستندات المرفقه في الطلب متعلقه بالنبود المطلوبه. المواد الكيمياييه (٥) ان الاجهزه والمستلزمات الطبيه ذات العلاقه لا تحتوي علي اي ماده كيمياييه من المواد الموضحه في الجداول الملحقه في اتفاقيه حظر الاصلحه الكيمياييه ولا تحتوي في تركيبها اي من تلك المواد. (٦) ان الاجهزه والمستلزمات الطبيه ذات العلاقه لا تحتوي علي اي مواد مخدره او متجهزه او مشعه او اي مواد محظوره غير الموضحه اعلاه. (٧) ابلاغ وزاره الداخليه قبل نقل المواد الكيمياييه الخطره. (٨) الاحتفاظ بالمستندات وسجلات بيانات الكميات الوارده والمنصرفه والاستهلكه سنويا. النقل والتخزين (٩) مراعاه شروط النقل والتخزين حسب اشراطات ومتطلبات المصنع والهييه العامه للغذاء والدواء والجهات الحكوميه (الاخري ذات العلاقه مع ايضاح مكان التخزين بعد فسح الارساليه (الشحنه). (١٠) سحب الاجهزه والمستلزمات الطبيه من الجمارك لحظه وصولها دون اي تاخير كما نتحمل اي مسيوليه تترتب علي هذا التاخير. الاجراءات الجمركيه (١١) احضار اصل الفاتوره وشهاده المنشا لدي منفذ الوصول. العاملين (١٢) الافراد القايمين بالعمل مؤهلون علميا وعمليا المشكلات والحوادث (١٣) ابلاغ المركز الوطني لبلاغات الاجهزه والمنتزمات الطبيه (NCMDR) بالبهينه عن اي حوادث او مشكلات ذات علاقه بالجهاز/المستلزم الطي ذو العلاقه. Page 26 of 44 MDS-REQ-005-V5/230719 (١٤) التعاون مع الهييه و/او المصنع و/او الممل المعتمد في انشطه الرقابه بعد التسويق وتشمل التحقيق في البلاغات ومتابعه الاجراءات التصحيحيه علي الجهاز/المستلزم الطي ذو العلاقه. الدعايه والاعلان (١٥) عدم اصدار اي ماده دعاييه او اعلانيه للجهاز او المستلزم الطي ذو العلاقه الا اذا كان حاصلا علي الاذن بالتسويق لالجهزه والمستلزمات الطبيه. الاستخدام (١٦) الا تستخدم الاجهزه والمستلزمات الطبيه ذات العلاقه الا في الاغراض المورده من اجلها فقط، وعدم تداولها في غير الاماكن المخصصه لذلك، وتحمل جميع الاضرار الناجمه عن سوء الاستخدام او استخدامها في غير الغرض الذي وردت من اجله. تعهدات اضافه: تعهدات اضافه متعلقه بالاذن بالاستيراد للاجهزه والمستلزمات الطبيه المستعمله عدم تداول الاجهزه والمستلزمات الطبيه ذات العلاقه بالمملكه حتي بعد صيانتها او تجديدها، واعاده تصديرها بعد صيانتها او تجديدها واخطر الهييه عند تصديرها مع احضار ما يثبت ذلك، ملاحظه: لا ينطبق ذلك عند الرغبه بتدداول الجهراز/المستلزم الطبي المجدد، بشرط الاتزام بالماديين (٢٠/٤) من "اللاحنه التنفيذيه لنظام الاجهزه "والمستلزمات الطبيه" تعهدات اضافه متعلقه بالاذن بالاستيراد لغرض العرض (١٧) عدم اصدار اي ماده دعاييه او اعلانيه للجهاز او المستلزم الطي ذو العلاقه الا اذا كان حاصلا علي الاذن بالتسويق لالجهزه والمستلزمات الطبيه، ويمكن تقدمي بعض التفاصيل عنها للمختصين فقط (١٨) الا يستخدم الجهاز/ المستلزم الا بعد وجود بطاقه تعرفيه (ملصق خارجي) علي الجهاز/المستلزم الطي (او احمد حاوياته او اغلفته ان تعذر ذلك) ذو العلاقه، بالغه العربيه و/او الانجليزيه، تتضمن ان الجهاز/المستلزم الطي مخصص للعرض فقط وليس للبيع. (١٩ اعاده تصدير الاجهزه والمستلزمات الطبيه ذات العاقه باتريخ (سنه اشهر كحد اقصي) او اتلافها (MDS) (وفقا لمتطلبات الاتلاف المشار اليها في "متطلبات رقابه ما بعد التسويق للاجيده والمستلزمات الطبيه -) ("REQ11") مع تقديم ما يثبت ذلك للبييه، وعندما لا يمكن تطبيق ذلك فيجب تقدم مسوغ مقيول لدي البييه. تعهدات اضافه متعلقه بالاذن بالاستيراد لضراض الدراسات السريريه (٢٠) الا يستخدم الجهاز/ المستلزم الا بعد وجود بطاقه تعرفيه (مقص خارجي) علي الجهاز/المستلزم الطي (او احمد حاويه او اغلفته ان تعذر ذلك) ذو العلاقه، بالغه العربيه و/او الانجليزيه، تضمن ان الجهاز/المستلزم الطي مخصص للدراسات السريبه فقط. Page 27 of 44 MDS-REQ-005-V5/230719 (٢١ اعاده تصدير الاجهزه والملتزامات الطبيه ذات العلاقه بعدما ينتهي الغرض الذي جلب من اجلها او اتلافها (وفقا "متطلبات الاتلاف المشار اليها في "متطلبات رقابه ما بعد التسويق للاجهزه والملتزامات الطبيه (MDS-REQ11) مع تقدميم ما يثبت ذلك للهيثه، وعندما لا يمكن تطبيق ذلك فيجب تقدمي مسوغ مقبول لدي الهيثه. تعهدات اضافه متعلقه بالاذن بالاستيراد لغرض التعليم او الابحاث غير السريريه (٢٢) الا يستخدم الجهاز/المستلزم الا بعد وجود بطاقه تعريفيه (ملصق خارجي) علي الجهاز/المستلزم الطي (او احمد حاوياته او اغلفته ان تعذر ذلك) ذو العلاقه، باللغه العربيه و/او الانجليزيه، تënضمن ان الجهاز/المستلزم الطي مخصص للتعليم او الابحاث غير السريبه فقط. 23) اعاده تصدير الاجهزه والملستلامات الطبيه ذات العلاقه بعدما ينتهي الغرض الذي جلب من اجلها او اتلافها (وفقا "متلطبات الاتلاف المشار اليها في "متططبات رقابه ما بعد التسوبق للاجهه والملستلام مات الطيه (MDS-REQ11) مع تقدمي ما يثبت ذلك للهينه، وعندما لا يمكن تطبيق ذلك فيجب تقدمي مسوغ مقبول لدي الهينه. تعهدات اضافه متعلقه بالاذن بالاستيراد للاجره والملستلزمات الطبيه لغرض انساني (وتشمل الاجره الطبيه المصنعه (سب الطلب) (٢٤) الا يستخدم الجياز/المستلزم الا بعد وجود بطاقه تعريفيه (ملصق خارجي) علي الجياز/المستلزم الطي (او احمد حاويته او اغلفته ان تعذر ذلك) ذو العلاقه، باللغه العربيه و/او الانجليزيه. تتضمن ان الجياز/المستلزم الطي مصنع حسب الطلب، وذلك في حال استيراد الاجهزه الطبيه المصنعه حسب الطلب. (٢٥ اعاده تصدير الاجهزه والملتزامات الطبيه ذات العلاقه بعدما ينتهي الغرض الذي جلب من اجلها او اتلافها) وفقا " (MDS-REQ11) لمتطلبات الاثقال المشرا اليها في " متطلبات رقابه ما بعد التسويع للاجهزه والملستزامات الطبيه" (MDS-REQ11) مع تقدميم ما يثبت ذلك للهييه، وعندما لا يمكن تطبيق ذلك فيجب تقدمي مسوغ مقبول لدي الهييه. تعهدات اضافه متعلقه بالاذن بالاستيراد لغرض التصنيع المحلي (٢٦) ان تتوافق الكميه المستورده مع مخرجات الانتاج. (MDS-REQ1) ان يتم حصول الاجهزه والمستلزمات الطبيه ذات العلاقه علي الاذن بالتسويق بعد تصنيعها (انظر تعهدات اضافيه متعلقه بالاذن بالاستيراد للاجهزه والمستلزمات الطبيه المستعمله المراد استيرادها لفرض صيانتها بالملكه ثم اعاده تصديرها (٢٨) ان تتم الصيانه في منشاه حاصله علي رخصه صيانه للاجهزه والمستلزمات الطبيه. <table><tr><td colspan="2">التوقيع(1)</td></tr><tr><td></td><td>اسم الشخص المسؤول</td></tr><tr><td></td><td>المسي الوظيفي</td></tr><tr><td></td><td>التاريخ</td></tr></table> Page 28 of 44 MDS-REQ-005-V5/230719 <table><tr><td>التوقيع</td></tr><tr><td>الختم</td></tr></table> Page 29 of 44 MDS-REQ-005-V5/230719 Annex (3): Declaration and Attestation of Health Practitioner Click here for printable and editable version <table><tr><td colspan="2">Medical Device</td><td colspan="2">الجهاز والملتازم الطي</td></tr><tr><td>الكميهQty</td><td>الغرض من الاستخدامIntended Use</td><td>الموديلModel</td><td>اسم الجهاز/المتازم الطيMedical Device Name</td></tr><tr><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td>3</td></tr><tr><td colspan="4">Justifications:</td></tr><tr><td colspan="2"></td><td>اذكر التشخيص او العلاج او الوقايه الذي تم من اجله طلب هذا الجهاز/المتازمProvide the diagnosis, treatment or prevention for which the device is required</td><td>1</td></tr><tr><td colspan="2"></td><td>ذكر اسباب اختيار هذا الجهاز/المتازم غير المسجل علي الجهاز/المتازم لامملكه او العلاجات التقليديه لها المرض الحددProvide the reasons why this unregistered device was chosen over a registered device within the KSA or conventional therapies for this particular patient</td><td>2</td></tr><tr><td colspan="2"></td><td>وضع وعدد المخاطر والفواتmid المربطه باستخدام هذا الجهاز/المتازم ووضع كيف ان فوايده المرجوه ستفوق مخاطرهIdentify and list the risks and benefits associated with the use of the device and indicate how the benefits obtained would outweigh the risks</td><td>3</td></tr><tr><td colspan="2"></td><td>قارن مخاطر هذا الجهاز/المتازم غير المسجل بالملكه بالعلاجات التقليديه Compare the risks of the unregistered device within the KSA with conventional therapies</td><td>4</td></tr><tr><td colspan="2">Declaration:</td><td colspan="2">الاقرار:</td></tr></table> افر بالاتي: (1) اني علي دراسه كامله بالمخاطر الصحيه للجهاز او المستلزم الطي المطلوب وفوايده مقارنه بالعلاجات التقليديه او الجهزه البديله المتوفره في السوق. (2) ان لدي المام بالمعلومات المتاحه عن سلامه واداء الجهاز/المستلزم الطي المطلوب. (٣) ابلاغ المركز الوطني لبلاغات الاجهزه والملستلزمات الطبيه (NCMDR) بالهينه عن اي حوادث او مشكلات ذات علاقه بالجهاز/المستلزم الطي. (٤) عدم اعاده استخدام الاجهزه والملستلزمات الطبيه علي مريض اخري غير الذي جلبت من اجله، واعاده تصديرها بعدما ينتفي الغرض الذي جلب من اجلها او اتلافها مع تقدميم ما يثبت ذلك للهينه، وعندما لا يمكن تطبيق ذلك فيجب تقديم مسوغ مقبول لدي الهينه. Page 30 of 44 MDS-REQ-005-V5/230719 (٥) التعاون مع الهييه واو المصع و/او المملد و/او المستورد و/او الموزع في انشطه الرقابه بعد التسويق وتشمل التحقيق في البلاغات ومتابعه الاجراءات التصحيحيه علي الجهاز/المستلزم الطي. (٦) ان الاتي تم شرحه او سيتم شرحه للمريض و/او ذويه: - ان الهييه العامه للغذاء والدواء لا تضمن سلامه وكفاءه وجوده الاجهزه والمستلزمات الطبيه الميكوره اعلاه وادايها للغرض الذي صنعت من اجله، وان هذه الاجهزه والمستلزمات غير مسجله في المملكه ولكن قد يوافق عليها تحت تدابير خاصه. - ايضاح المخاطر المحتمله لاستخدم الاجهزه والمستلزمات الطبيه الميكوره اعلاه والفوايد المرجوه 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 distributor 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 هويه المريض: Patient's ID: اسم الممارس الصحي: Healthcare Professional's Name: جهه عمل الممارس الصحي: Healthcare Professional's Organization : توقيع الممارس 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] نموذج اقرار وتعهد المستفيدين من المنتجات البحثيه (يطبع علي الورق الرسي الخاص بالستفيد) اضغط هنا لنسخه قابله للطباعه والتعديل التاريخ: سعاده / نايب الرييس التنفيذي لقطاع العمليات المحترم بناه علي التعميد رقم / والصادر بتاريخ والالمتعلق بتوريد اجهزه ومستلزمات طبيه للاستخدام البحثي او التعليمي ادناه داخل المنشاه المعنيه <table><tr><td>شركه المصنعه</td><td>الكميه</td><td>اسم الجهاز/المستلزم</td><td>م</td></tr><tr><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td>3</td></tr><tr><td></td><td></td><td></td><td>...</td></tr></table> نتعهد بعدم استخدام الاجهزه والمستلزمات المذكوره اعلاه في التطبيقات الطبيه العلاجيه او التشخيصيه وانما يقتصر استعمالها علي المجال البحثي او التعليمي فقط، بغض النظر عن كفاءتها للاستخدامات العلاجيه او التشخيصيه. ولكم جزيل الشكر والتقدير، <table><tr><td colspan="2">التوقيع</td></tr><tr><td></td><td>اسم الشخص المسؤول</td></tr><tr><td></td><td>المسي الوظيفي</td></tr><tr><td></td><td>التاریخ</td></tr><tr><td></td><td>التوقيع</td></tr><tr><td></td><td>الختم</td></tr></table> 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] نموذج اقرار وتعهد مقدمد الرعايت الصحيت للاستيراد في حالات الطواري العام اضغط هنا لنسخه قابله للطباعه والتعديل يظهر علي الورق الرسي الخاص بمقدم الرعايه الصحيه بالرجوع الي التعميد رقم بادرج و الصادر بتاريخ نرغب باستيراد الاتي لغرض خاص وطاري لمشاتنا فقط: <table><tr><td>المسوغات*</td><td>اسم المصنع</td><td>الكميه</td><td>اسم الجهاز/المستلزم الطي</td><td>م</td></tr><tr><td></td><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td></td><td>3</td></tr></table> * يجب ذكر المسوغات التي توضح بان الاستيراد طاري في حال استيراد اجهزه او مستلزمات طبيه غير حاصله علي الاذن بالتسوويق، يجب ذكر مسوغات عدم تامينه من البديل الحاصل علي الاذن بالتسويت. وفي حال ان المستورد غير حاصل علي رخصه مستورد للاجهزه والملستزمات الطبيه، يجب ذكر مسوغات ذلك. نقر نحن والدواء لا تضمن سلامه وكفاءه وجوده الاجهزه والملستزمات الطبيه الميكوره اعلاه وادناها للغرض الذي صنعت من اجله. وسيكون استيرادها تحت مستلوليتنا، ونتعهد بانها لن تستخدم الا في منشاننا فقط ولن نقوم باستخدمها في اي مكان اخري او اعاRTHA الا بموافقه الهييه. ونتعهد ابلاغ المركز الوطني لبلاغات الاجهزه والمستلزمات الطبيه بالهييه العامه للغذاء والدواء عن اي اشعار انذار السلامه او استدعاعات او اي احداث سلبيه ذات علاقه بالاجهزه والمستلزمات الطبيه المذكوره اعلاه فور العلم بها سواء وقعت داخل المملكه، او وقعت خارجها ولها عواقب علي الاجهزه والمستلزمات الطبيه في المملكه، وذلك (http://ncmdr.sfda.gov.sa): عبر الرابط التالي ولكم جزيل الشكر والتقدير،... <table><tr><td colspan="2">التوقيع</td></tr><tr><td></td><td>اسم الشخص المسؤول</td></tr><tr><td></td><td>المسي الوظيفي</td></tr><tr><td></td><td>التاريخ</td></tr><tr><td></td><td>التوقيع</td></tr><tr><td></td><td>الختم</td></tr></table> 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] <table><tr><td>General Information</td><td>معلومات عامه</td></tr><tr><td>Invoice No.:</td><td>رقم الفاتوده:</td></tr><tr><td>Customs Ports:</td><td>المنفذ الجمركي:</td></tr><tr><td>Destination Country:</td><td>الدوله المصدر لها:</td></tr><tr><td>Establishment Information</td><td>معلومات المنشاه</td></tr><tr><td>Establishment Name (in Arabic):</td><td>اسم المنشاه (باللغه العربيه):</td></tr><tr><td>Commercial Registration No.:</td><td>رقم السجل التجاري:</td></tr><tr><td>Establishment Account of GHAD system</td><td>رقم المعرف/حساب المنشاه في “نظام غد”</td></tr><tr><td>National Address:</td><td>العنوان الوطني:</td></tr></table> Page 34 of 44 MDS-REQ-005-V5/230719 <table><tr><td colspan="6">Medicinal Devices Information</td><td colspan="2">معلومات الاجهزه والملتزمانات الطبيه</td></tr><tr><td>الوحدهUnit</td><td>الكميهQty.</td><td>التعرفه الجمركهHS Code</td><td>رقم القيد الوطني للجهازاو المملازم الطيعدما ينطبق ذلكMedical Device National Listing Numberif applicable</td><td>الرقم التسلسلي/التشغيليه/المجموعه فقط للاجهزه والملتزمانات التيستعداد الي المملكهSerial/Batch NumberOnly for devices that will return to KSA</td><td>طرازالجهاز او المملازم الطي</td><td>الاسم التجاري للجهاز اوالمملازم الطيMedical Device Brand Name</td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>3</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>4</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>5</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>6</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>7</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>8</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td>..</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td>-</td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td>-</td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td>-</td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td>-</td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td>-</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td>-</td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>-</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table> 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 occurring. - I certify that all attached documents are stamped by company's stamp and considered as an official copy. I take the extreme responsibility for any forgery or incorrect information on these documents. - I certify to comply with the “Law of Medical Devices” and its executive regulations, and relevant requirements, circulars and decisions. - I certify to keep the relevant documents, records, and records of production lines outcomes and provide them to the SFDA upon request. - اتعهد بان جميع الوثايق المرفقه والمختومه بختم المنشاه هي نسخ طبق الاصل، واذا ظهر خلاف ذلك فان ايق براتكاب التزوير في الوثايق وتحمل ما يترتب علي ذلك من الجزاء النظامي. - اتعهد بالالتزام بمقتضي "نظام الاجهزه والملتزمات الطبيه" $ والاتجهه التنفيذيه والمتطلبات والتعاميم والقرارات ذات العلاقه - اتعهد بالاحتفاظ بالوثايق والسجلات ذات العلاقه وسجلات مخرجات خطوط الانتاج وتقديمها للهييه عند طلها. <table><tr><td>Signature</td><td>التوقيع</td></tr><tr><td>Name of authorized person:</td><td>اسم الشخص المفوض:</td></tr><tr><td>National ID:</td><td>رقم الهويه الوطنيه:</td></tr><tr><td>Mobile No.:</td><td>رقم الجوال:</td></tr><tr><td>Signature:</td><td>التوقيع:</td></tr><tr><td>Establishment Stamp:</td><td>ختم المنشاه:</td></tr></table> Page 36 of 44 MDS-REQ-005-V5/230719 Annex (7): Medical Devices Shipments Procedures <table><tr><td>Prohibited Medical Devices</td><td>The following products are prohibited from importation: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.</td></tr><tr><td>Storage, Transportation, Product Shelf Life and Labeling</td><td>A. Storage and Transportation of Product:Manufacturer's instructions for the storage, handling, and transport of products they import shall be complied, and when transportation or storage requires specific temperatures or humidity, an electronic 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.</td></tr></table> Page 37 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td>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.</td></tr><tr><td>Samples Withdrawal</td><td>SFDA withdraws random samples of imported shipments at POEs in 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.</td></tr><tr><td>Relevant POEs</td><td>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).</td></tr><tr><td>Document Retention</td><td>The originals of documents submitted to the SFDA shall be kept for five years from the date of shipment clearance, and shall be submitted to the SFDA when requested.</td></tr><tr><td>Approval Procedure</td><td>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</td></tr></table> Page 38 of 44 MDS-REQ-005-V5/230719 <table><tr><td></td><td>submitting an objection letter according to the "objection procedure to the refusal …(9,088 more chars)