English — official EDA PDF (current v02/2025 file on the guidelines index)

8.1 Appendix I: Documents for an import permit (imported devices)

8.1.1 Documents required to obtain import permit for registered sterile devices 8.1.2 Documents required to obtain import permit for non-sterile medical devices 8.1.3 Documents required to obtain import permit for medical devices as samples

8.2 Appendix II: Documents for import permits for medical events

8.3 Appendix III: Documents for a research protocol

protocol

8.4 Appendix IV: Documents for production inputs, components, and raw materials

raw materials for local medical devices factories

8.5 Appendix V: Documents for custom release

8.5.1 In the case of importing samples for registration 8.5.2 In the case of importing devices for which an import permit has been issued 8.5.3 In the case of importing export devices that have an annual import plan

8.6 Appendix VI: Documents for annual import plans

8.7 Appendix VII: Documents for specialized scientific committees

8.7.1 (Orthopaedic Committee) 8.7.2 In the case of medical devices in dosage forms 8.7.3 Medical devices of all types (general)

8.8 Appendix VIII: Documents for special import requests

8.8.1 In the event that the imported device is a donation for hospitals 8.8.2 In the event that the hospital is the importer 8.8.3 In the event that an individual imports a product for personal use 8.8.4 In the event that the device is imported by a physician 8.8.5 In the event that the device is imported by a company with activities related to medical devices 8.8.6 In the event that the device is imported by a company with activities not related to medical devices

8.9 Appendix IX: Documents for a letter of lack of jurisdiction

8.10 Appendix X: Quality and trading certificates by classification

Version number/year:02/2025 Appendix I 8. Documents required for each type of application 8.1.1 Documents required to request import approval for registered medical devices 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. Payment receipt with the invoice number supplied and stamped with the Authority’s stamp. 3. Proforma invoice 4. In the case of repair and restoration of cochlear implant: the invoice with which the export was made is required 5. The report on the repair and restoration of cochlear implant 6. In the case of tenders for the Unified Purchasing Authority: It is required to determine whether the storage location is in the warehouses of the Authority or in the importing company. 7. A license of medical devices importers registerer, in addition to the importing or manufacturing company 8. Form-14(c14) for agents if indicated in the registration license 9. The distribution or agency contract with the supplier is valid, if referred to in the registration license or mentioning the term “for some products”, authenticated by the Chamber of Commerce and the Egyptian Embassy. - In the case of tenders: A tender contract and authorization of the agent is required to complete the procedures for obtaining the necessary import permits. 10. In the case that the manufacturing company and supplier are different: The relationship shall be shown, including the supplier’s right to supplying the devices imported into Egypt, issued by the foreign factory and authenticated by the Chamber of Commerce and the Egyptian Embassy. 11. A valid notification of registration issued by the General Administration of Registration 12. In the case of variation of a registered medical device (the presence of any discrepancy between the notification data and the device data indicated in the invoice): Submit letters issued by the Variations Department at the General Administration of Registration regarding notification of registration. Or Submit the initial acceptance number for requesting variations to the General Administration of Registration 13. In the event of certificates including different postal codes: Submit a clarification letter issued by the manufacturer stating that the change appearing in some numbers in the manufacturer’s address is a change in the postal code. 14. If some data related to what is required in the notification is not clear when compared with the invoice or renewed quality certificates: Manufacturer’s manual(catalogue)l is presented, explaining the use of the product, its models and codes. 15. If some data is not clear after matching the notification, invoice, and renewed certificates, a Declaration Certificate will be requested, including but not limited to the address of one of the manufacturers and the classification of the product. 16. In the event of the expiration or invalidity of the trading and quality certificates (free sale +CE or FDA) mentioned in the notification of registration: They shall be submitted as indicated in the classification shown in Appendix X. Version number/year:02/2025 17. If the FDA certificate contains a factory under the name Owner/ Operator, the legal factory shall submit a letter explaining the status of each of them is submitted. 18. The specialized scientific Committee’s decision to approve the import of the devices (in the case of individuals or hospitals importing sterile devices that are not registered or custom made). 19. If the registration applicant name mentioned in the valid notification of registration (an item previously registered for another entity) differs from that of the applicant and the original notification is not present with the new agent, the following shall be submitted: - The notarized contract between the new agent and the foreign company, - A letter issued by the foreign supplier stating the end of the contractual with the old agent, - The initial acceptance number for the registration file at the General Administration of Registration. Note: Refer to Item No. 1 in the instructions below. Special guidance: 1. As for medical devices submitted for registration (new registration), they will not be released except after the issuance of their notification of registration, except in the following two cases: - The item was previously registered and there is a change in the raw materials of the item submitted for registration from the registered item. - The item was previously registered with only a change in the name of the applicant and other variations within the variation list. In both cases, the company is given a period of one year for release, starting from the date of acceptance of the file by the General Administration of Registration. 2. Regarding medical devices submitted for re-registration: - The file acceptance number is provided by the General Administration of Registration If the data provided to the administration is identical with that coming from it, the company will be given a period of one year for release, starting from the date of acceptance of the file. 8.1.2 Documents required to obtain an import approval for non-sterile medical devices 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. Proforma invoice 3. The registration license of medical devices importers register: * Added to the supplier or manufacturer based on the relationship letter 4. Form-14 for agents if indicated in the registration license. 5. The distribution or agency contract with the supplier is valid and authenticated by the Chamber of Commerce and the Egyptian Embassy - In case of tenders, the tender contract and the agent’s authorization are presented. 6. In the event that the manufacturing company differs from the supplier: the relationship between them is presented, including the right of the supplier to device the devices imported into Egypt, issued by the foreign factory, authenticated by the Chamber of Commerce and the Egyptian Embassy. Version number/year:02/2025 7. The payment receipt, stamped by the administration and the invoice number is written on it. 8. Regarding hospitals: Submit the hospital license issued by the Free Therapy Administration and the Commercial Registry stating that the hospital’s activities include the importing of medical devices or that it is subject to the Investment Authority Law. 9. A valid notification of registration issued by the General Administration of Registration or Provide the initial registration file acceptance number for the devices subject to registration 10. In the case of variations (the presence of any discrepancy between the notification data and the data of the requirement mentioned in the invoice), submit the letters issued by the Variations Department at the General Administration of Registration with respect to the notification of registration. or submit the initial acceptance number for requesting variations to the General Administration of Registration. 11. If the name of the applicant for registration in the valid notification of registration (a device previously registered for another entity) differs from that of the applicant and the new agent does not have the original notification, submit the following: - The notarized contract between the new agent and the foreign company. - A documented letter issued by the foreign supplier stating the end of the contractual relationship with the old agent - The initial acceptance number for the registration file at the General Administration of Registration 12. If the postal codes in the certificates are different, submit a clarification letter issued by the manufacturer stating that the apparent difference in some numbers in the manufacturer’s address is a change in the postal code of quality certificates. 13. The manufacturer’s manual showing the medical devices contained and their conformity (model or code), indicating the intended use. If the manual does not explain how to use it, submit a letter from the manufacturer explaining the intended use. 14. the trading and quality certificates required according to the classification: Appendix X 15. If the device is in dosage form, refer the device together with the above documents - according to classification – to the specialized scientific committees to obtain import permit. 16. In the case of dental devices, the following must be submitted: - Hand pieces: Provide evidence that they are autoclavable by submitting the original factory manual, a certified letter of origin from the manufacturer, or the manufacturer’s official website. - In the event of importing components, adhesives, amalgam capsules, files, burs, examination gloves (or any new items in accordance with the decision of the Scientific Committee): A sample shall be drawn annually from the incoming shipment for analysis at one of the agencies Version number/year:02/2025 accredited by EDA, to be determined by the competent administration before issuing the import permit. If a decision is issued to conform to the specifications, an import permit will be issued. 17. In the event of importing medical gas outlets, ceiling pendant or bed head unit from a non-reference country, a free sale certificate from a reference country shall be presented. Instructions for obtaining an import permit for a non-sterile medical device: 1. Regarding non-sterile surgical instruments, non-sterile laparoscopic surgery instruments, and non- sterile orthopaedic surgical devices that are transplanted within the body coming from a non-reference country: Samples are drawn from the first shipment for analysis at an accredited body determined by the competent administration, and its technical report is considered valid for a full year for the same manufacturing materials and same manufacturer. 2. Regarding orthopaedic devices that are transplanted within the body coming from a non-reference country, inspectors of the Central administration of inspection on pharmaceutical institutions shall take samples for the purpose of analysis for each category at the Faculty of Engineering, Ain Shams University, and its technical report will be valid for a full year for the same manufacturing materials and same manufacturer. 3. Class IIb & III medical devices coming from non-reference countries are referred to specialized scientific committees. 4. Imported non-sterile medical gloves must be powder free, their brand name and the register of medical devices importers be written in the certificates, and samples be taken for analysis annually at the Faculty of Dentistry, Ain Shams University. 5. Import of oral and nasal route medical devices is only allowed after obtaining a notification of registration. 6. As for medical devices submitted for registration (new registration), they will not be released except after the issuance of their notification of registration, except in two cases: - It was previously registered and there is a change in the raw materials of the device submitted for registration from the registered item. - It was previously registered with only a change in the name of the applicant and other variations within the list of variations. In both cases, the company is given a period of one year for release, starting from the date of acceptance of the file by the General Administration of Registration. 7. Regarding medical devices submitted for re-registration: - The file acceptance number is provided by the General Administration of Registration. If the data provided to the administration is identical with that coming from it, the company will be given a period of one year for release, starting from the date of acceptance of the file. Version number/year:02/2025 8.1.3 Documents for requesting an import approval for samples for any of the following purposes: • Evaluation and study • Presentation to scientific committees • Analysis • Marketing 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. Proforma invoice 3. A license of medical devices importers registerer, Or the license of the scientific office and the importing company. 4. In the case that the manufacturing company and supplier are different: The relationship shall be shown, including the supplier’s right to supplying the devices imported into Egypt, issued by the foreign factory and authenticated by the Chamber of Commerce and the Egyptian Embassy. 5. In the case of importing samples for evaluation for the first time, a letter is required from the manufacturer stating that there is no agent in Egypt. 6. Regarding hospitals: Submit the hospital license issued by the Free Therapy Administration and the Commercial Registry stating that the hospital’s activities include the importing of medical devices or that it is subject to the Investment Authority Law. 7. The payment receipt stamped with the Authority’s seals and the invoice number is written on it. 8. For the registered devices, submit a valid notification of registration issued by the General Administration of Registration. To apply for registration, provide the acceptance number of the initial registration file for the devices subject to registration. 9. For variations (the presence of any discrepancy between the notification data and the data of the requirement stated in the invoice), submit the letters issued by the Variations Department at the or Submit the initial acceptance number for the variation request to the General Administration of Registration. 10. The manufacturer’s manual showing the medical devices contained and their conformity (model or code) and explaining the intended use. 11. If the device is in dosage form, refer the device together with the above documents - according to classification – to the specialized scientific committees to obtain import permit. Instructions for importing samples: 1. Importing samples for evaluation or study: * Samples for sterile medical devices: - It is allowed to import a sample of each size or type, provided that the invoice quantity does not exceed 10 pieces. Version number/year:02/2025 - Submit certificates according to classification (Appendix X). - For a single item, samples are allowed to be imported only once for the same manufacturer, and the company is excluded from all quality certificates except the DOC and CE certificates. - If proof is presented that the product contained in a non-sterile form or in demo form is exempt from quality certificates * Samples for non-sterile devices: - Only one sample of each size or type is allowed to be imported, provided that the invoice quantity does not exceed 10 pieces. - All quality certificates are excluded and the declaration certificate will be considered sufficient, with the company’s pledge that if goods are brought, the company will be committed to all quality certificates. 2. Importing samples for scientific evaluation for presentation to the scientific committee: Invoice quantities must not exceed one piece of each item, with proof that the import is required for scientific evaluation and its quality certificates must be submitted in full according to the classification of the item. 3. Importing samples for analysis at the Faculty of Engineering to be presented to the specialized scientific committee: - The quantities mentioned in the invoice are required to be 3 pieces of each type. - In the absence of a contract with the manufacturer (supplier), the company is obligated to submit a letter from the factory stating that it does not have an agent in Egypt. - Quality certificates are provided according to classification. 4. Samples for marketing (advertising): Only scientific offices have the right to import samples for the purpose of advertising and marketing, printed on them that they are samples for advertising and not for sale. The central administration of licensing of pharmaceutical institutions shall verify this, and importing scientific offices are obliged to provide all quality certificates for the medical device according to its classification. Appendix II Documents required to obtain import approval for imported devices for medical events 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. ID card of the authorized person by the company 3. Proforma invoice indicating the date of the conference or the workshop if possible. 4. If the applicant is a company that imports medical devices, a license is required to register in the registerer of medical devices importers. Version number/year:02/2025 - In the event that the importing applicant is a scientific office, the license of the scientific office is required, in addition to the supplier 5. The manufacturer’s manual, indicating imported item. 6. For hospitals: - Submit the hospital license issued by the Free Therapy Administration - Submit the Commercial Registry stating that the hospital’s activities include the importing of medical devices or that it is subject to the Investment Authority Law. Instructions for requesting an import approval for devices imported for medical events: Instructions for requesting an import permit for non-sterile medical devices: - For the imported items that are used for workshops, training, conferences and scientific exhibitions, provided that they are not used on humans and are used on plastic models or human specimens in the Anatomy Department, import may be allowed, taking into account the following: - The date of the conference or workshop is mentioned in the invoice (if possible) If it is not mentioned in the invoice, submit a letter from the party hosting the event stating its date and venue. - The company is committed to providing proof of re-export immediately after the end of the workshop or conference, Central administration of inspection on pharmaceutical institutions - The party hosting the event shall submit a pledge that the imported item will not be used on humans. Appendix III Documents required to obtain import approval for imported devices for a research protocol 1. The importing company’s mandate to the university or person in charge of dealing with the being verified by the bank. 2. ID card of person mandated from the company, university or research body applying for import. 3. Proforma invoice indicating the No. of protocol, name of the researcher, and name of the university. 4. If the applicant is a company that imports medical devices, a license is required to register in the registerer of medical devices importers. - In the event that the importing applicant is a scientific office, the license of the scientific office is required. 5. Approval of the institutional committee for reviewing medical research ethics in the research body registered with the Supreme Council for Review of Clinical Medical Research Ethics, stating the protocol number, the name of the researcher, and the entities in which the clinical trials are being conducted. 6. A letter from the foreign factory stating the manufacturing locations, the country of origin of the imported items, and the country of origin if it differs from the supplier. 7. The manufacturer’s manual, indicating the content. 8. The payment receipt is stamped with the General Administration of Registration’s seals and the invoice number is written on it. Version number/year:02/2025 Instructions for submitting an import permit for a research protocol: In the event that companies or hospitals import sterile or non-sterile devices for use in protocols approved by the institutional committee for reviewing medical research ethics at the research entity, the available quality certificates will be issued (if available). Or Notification of registration, based on the original protocol provided. Appendix IV Documents required to obtain import approval for production inputs, components, and raw materials for local medical devices factories 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. Proforma invoice for items to be released. 3. Factory license (indicating factory’s activities) or factory data certificate issued by The central administration of licensing of pharmaceutical institutions affiliated with the Central Department of Operations 4. A valid industrial register (indicating factory’s activities) 5. Commercial register 6. Tax card 7. Operating license from the General Authority for Industrial Development 8. CE certificate for finished product 9. ISO13485:2016 certificate for the factory 10. An analysis certificate for the imported raw materials indicating their manufacturing standards 11. Declaration of conformity certificate 12. Valid notification of registration for the finished product (in the case of sterile devices) 13. In the case of submitting a re-registration file, submit the initial admission number 14. Conformity of materials and components stated in the notification of registration or composition statement if the final product is not sterile 15. List of approved suppliers for the factory. 16. Pledge of the factory’s responsibility for the availability of complete data on imports, without any responsibility on the part of EDA Special instructions: 1. Medical devices directly related to human blood are not permitted to be released in non-sterile bulk form, with the exception of medical gloves only. 2. Local factories may not import finished medical devices other than samples received for study and evaluation or similar manufacturing of single-use medical devices. 3. Imported raw materials and components must contain at least the following information: - Trade name (if present) - Product name Version number/year:02/2025 - Product code or Ref. (if applicable) - Batch number or lot no (if necessary) - Any special handling precautions (if present). - Any special storage precautions (if present). - Expiry date (at least in terms of year and month) in accepted format (if applicable): i.e., clear identification of the time limit for using the product (in month/year format at least). For example: expires on 12-2025 Or manufacturing date and shelf-life time; For example: manufactured on 12-2020, shelf life: 3 years 4. No raw materials or components will be released to produce any medical devices that do not meet the conditions for trading in the local market under any name. 5. Import is allowed if the factory wishes to import samples of raw materials or components for the purpose of production for evaluation or testing of the production line. 6. In the event of the imported shipment containing large quantities, the evaluation is carried out through the Import Committee. 7. In the case of variations (the presence of any difference in the raw materials stated in the notification of registration), the factory is obligated to submit letters issued by the Variation Department of the General Administration of Registration stating the necessary change to the notification of registration or the documents required to prove that the received raw materials conform to the specifications. 8. Factory is fully committed to using the imported materials and components contained for the purposes for which they were approved. 9. In the case of raw materials for dental devices, it is not permitted to import raw mercury or amalgam powder except to local factories that manufacture amalgam capsules, in accordance with the industrial registry. 10. In the event of importing polyurethane, it will be released until its expiration date. Appendix V Documents required for custom release 8.5.1 For importing samples for registration, the following are required: 1. A pledge on the importing company’s letterhead, signed and stamped by the manager in charge, stating that the imported item is for the purpose of registration and not for sale or trade. 2. The importing company’s mandate to the person in charge of dealing with the General Administration of (marketing authorization), signed and stamped by the company’s manager, with the signature being verified by the bank. Version number/year:02/2025 3. Commercial invoice, stamped by the factory, indicating the sequence of the number of pages and the country of origin for each item. Note: If the original commercial invoice is not submitted, provide a written pledge stating that the submitted invoice is identical to the original invoice submitted at the Customs Department and uploaded to the ACI system. 4. Company’s plan to submit a registration file with a pledge not to sell or trade and to hold legal responsibility for any violation. 5. Packing list included with the shipment. 6. A bill of lading linked to the commercial invoice. 8.5.2 For importing devices with import approval, the following are required: 1. A pledge on the importing company’s letterhead, signed and stamped by the manager in charge, stating that the invoice will not be opened unless an inspector from the Central administration of inspection on pharmaceutical institutions 2. The importing company’s mandate to the person in charge of dealing with the General Administration of (marketing authorization), signed and stamped by the company’s manager, with the signature being verified by the bank. 3. Commercial invoice, stamped by the factory, indicating the sequence of the number of pages and the country of origin for each item. Note: If the original commercial invoice is not submitted, provide a written pledge stating that the submitted invoice is identical to the original invoice submitted at the Customs Department and uploaded to the ACI system. 4. Company’s plan to submit a registration file with a pledge not to sell or trade and to hold legal responsibility for any violation. 5. The import approval (stamped) that the company previously obtained from the General Administration of (marketing authorization), accompanied by the proforma invoice. 6. Certificate of origin linked to the commercial invoice (in case the origin is not clearly stated on the invoice) 7. Packing list included with the shipment. 8. A bill of lading linked to the commercial invoice. 9. (Registration license) on which the invoice items are matched by numbers. 10. (Free sale) and quality certificates required according to the classification in the event they are expired/invalidated in the import permit. 8.5.3 For importing medical devices with annual import plan, the following are required: 1. A pledge on the importing company’s letterhead, signed and stamped by the manager in charge, stating that the invoice will not be opened unless an inspector from the Central administration of inspection on pharmaceutical institutions 2. The importing company’s mandate to the person in charge of dealing with the General Administration of (marketing authorization), signed and stamped by the company’s manager, with the signature being verified by the bank. 3. Commercial invoice, stamped by the factory, indicating the sequence of the number of pages and the country of origin for each item. Note: If the original commercial invoice is not submitted, provide a written pledge stating that the submitted invoice is identical to the original invoice submitted at the Customs Department and uploaded to the ACI system. Version number/year:02/2025 4. License of medical devices importers registerer, provided that it should include the importing or manufacturing company in accordance with the relationship letter 5. Form-14 for agents if indicated in the registration license 6. Valid distribution or agency contract with the supplier, if found in the license. 7. In the case that the manufacturing company and supplier are different: The relationship shall be shown, including the supplier’s right to supplying the devices imported into Egypt, issued by the foreign factory and authenticated by the Chamber of Commerce and the Egyptian Embassy. 8. If the address of the importing company in the invoice differs from its address in the License of medical devices importers registerer, submit the tax card and commercial register of the importing company. 9. The valid import plan the company had previously obtained from the General Administration of (marketing authorization). 10. (Free sale) and quality certificates required according to the classification in the event that they expire/are not valid in the import plan. 11. Certificate of origin linked to the commercial invoice (in case the origin is not clearly stated on the invoice). 12. Packing list included with the shipment. 13. A bill of lading linked to the commercial invoice. 14. Valid Registration License Appendix VI Documents required to obtain annual import plans First: Registered medical devices 1. The importing company’s mandate to the person in charge of dealing with the General Administration of Marketing Authorization, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. License of medical devices importers registerer, in addition to the importing or manufacturing company in accordance with the relationship letter 3. Form-14 for agents 4. The distribution or agency contract with the supplier, valid and authenticated by the Chamber of Commerce and the Egyptian Embassy if it is referred to as a registration license or mentions the term for some products. 5. In case of the manufacturer differs by notifying the said company of the licence to register, a contract shall be requested between them, including the supplier's entitlement to supply supplies to Egypt or the Middle East issued by the foreign factory documented by the Chamber of Commerce and the Egyptian Embassy. 6. A valid Registration License issued by the General Administration of Registration. 7. In the case of variations, submit letters issued by the General Administration of Registration (Variation Administration) regarding the Registration License. Version number/year:02/2025 8. If there is a change in the Registration License (for example, cancellation of codes or change in factory data): • Provide the variation file acceptance number for the notification of registration, • Provide a pledge to complete the import plan before one year has passed from the date of acceptance of the variation file. 9. In the event of cancellation of codes or packages: • Manufacturer shall submit a letter indicating its responsibility and explaining all the reasons for deleting the code or packaging, • Importer shall submit a pledge to adhere to the procedures followed by the General Administration for Pharmaceutical Vigilance. 11. In the event that some data related to what is required in the notification or renewed quality certificates is not clear, present the manufacturer’s manual, explaining the use of the product, its models, and its codes. 12. A clarification letter in case some data mentioned in the notification and documents are not clear. 13. The last import plan obtained for renewing the plan. 14. If the postal codes in the certificates are different, submit a clarification letter issued by the manufacturer stating that the apparent difference in some numbers in the manufacturer’s address is a change in the postal code. 15. In the event that one or all of the Free Sale and quality certificates are expired or no longer valid in the Registration License, the valid renewed certificates shall be submitted according to classification (Appendix 10). Second: Production raw materials and components for manufacturing medical devices for all raw material suppliers to the factory The procedure is optional for the factory, as the factory has the right to apply for an annual import plan for its raw materials or to apply for an import permit for each invoice separately. The Central Administration for Medical Devices issues an annual import plan for raw materials and production components for the production of medical devices to all suppliers of raw materials to the factory for the fiscal year. The Central Administration for Medical Devices examines the applications and issues an annual import plan that includes the list of required documents, which are as follows: 1) A statement of suppliers list signed and stamped by the factory’s manager, 2) Data certificate issued by the central administration of licensing of pharmaceutical institutions 3) The factory’s mandate to the person in charge of dealing with the General Administration of Marketing Authorization, signed and stamped by the company’s manager, with the signature being verified by the bank, 4) Factory license (indicating the factory’s activities), Version number/year:02/2025 5) A valid industrial register (indicating the factory’s activities), 6) Commercial register, 7) Tax card, 8) Valid CE certificate for finished product, 9) Valid ISO 13485:2016 certificate for the factory, 10) Finished product Registration License (in case of sterile devices) 11) Pledge of the factory’s responsibility for having complete data on imported items and submitting a request to update the supplier list in the event of adding or changing a raw material or a supplier, 12) Material safety data sheet for each material from each supplier, 13) Excel sheet stating the following: Name of the material, name of the supplier/s, name of the final product, and numbers of Registration License that are used in manufacturing the product. 14) A pledge from the factory, signed and stamped by the factory’s manager, stating the factory’s commitment to update the documents and data provided in the event of any update or change and once a year at least 20 working days before the annual import permit renewal date. - The annual import plan is effective as of 1 st July until 30 th June of each year. - The submitted documents are updated according to the situation (i.e., if one or some of the documents expire or are updated). An approval shall be issued for the final release of each invoice separately after comparing the items with the invoice received with the annual import plan and ensuring the validity of the certificates and documents on which the plan was issued. General guidance for import plans 1. For the following cases: - Registered medical devices for which a request has been submitted to amend data in the Registration License with the Variations Department: Annual import plans are issued for registered medical devices based on the data actually stated in the Registration License, and then the annual import plan is completed after a letter is issued approving the changes. - Cancelling codes or cancelling a package and the code or package has been deleted from the certificates (free sale and/or CE certificate): An import plan is be issued for the codes and packages mentioned only in the renewed certificates, and: ✔ Submit a letter on the manufacturer’s responsibility, indicating all the reasons for deleting the code or packaging, ✔ Adhere to the procedures followed by the General Administration for Pharmaceutical Vigilance. Version number/year:02/2025 - Deleting or changing the name of an actual factory and/or its address in the certificates (free sale, CE certificate and/or declaration of conformity): An import plan is be issued only for the factories mentioned in the certificates submitted. 2. The annual import plan for each registered medical device is submitted and approvals for this plan are obtained once a year through the Customs Release Unit and Follow-up through the Inspection Department of the Central administration of inspection on pharmaceutical institutions. 3. Quantities are not specified in the import plan by importing companies. 4. Each invoice is released separately. 5. In the event of importing items not included in the annual import permit, an import Approval will be issued for each invoice separately based on the company’s request. Appendix VII Documents related to requests for presentation to specialized scientific committees • The required trading and quality certificates are provided in accordance with the classification (Appendix X) • Submit a sample for presentation to the scientific committee. • If the committee issues a decision valid for one year providing for re-evaluation by the Medical Supplies Safety Department, then after the issuance of the Scientific Committee’s decision, a signed and sealed list of the names of hospitals to which the supply was made will be submitted, so that the Safety Department can conduct questionnaires to verify the safety and effectiveness of the device and present them to the Scientific Committee for evaluation 8.7.1 For Orthopaedic devices, the following are required: 1. Analysis result of non-sterile orthopaedic devices conducted by the Faculty of Engineering, Ain Shams University, 2. catalogue 3. Quality and trading certificates as shown in the certificate table according to the classification 4. In the absence of a trading certificate from a reference country and the presence of previous approvals, submit a signed and stamped list of the names of hospitals to which the device was made so that the Safety Department can conduct questionnaires to verify the safety and effectiveness of the device. 8.7.2 Medical devices in dosage forms 1. Declaration from manufacturer showing intended use, each ingredient and its function 2. catalogue or inner leaflet +Art work 3. Quality and trading certificates as shown in the table of certificates according to classification 4. Clinical studies (if requested by the Scientific Committee) 8.7.3 Medical devices of all kinds Version number/year:02/2025 1. Intended use certificate: The items written in the DOC must be for the same intended use. 2. In the absence of a trading certificate from a reference country for medical devices classified as Class IIb, submit a signed and sealed list of the names of hospitals to which the devices were made so that the Safety Department can conduct questionnaires . 3. A catalogue 4. Quality and trading certificates as shown in the certificates table according to the classification. 5. Clinical studies (if requested by the Scientific Committee). Appendix VIII Documents required for special import requests 8.8.1 If the imported device is a donation for hospitals, the following are required: 1. A letter of acceptance of the donation for any institution or ministry. The letter must be issued by an authorized body, and must be signed and sealed by the general manager of the institution or facility (based on Cabinet Resolution No. 1818 of 2019). If the value of the invoice exceeds one million pounds and does not exceed 10 million pounds, the approval of the competent minister or whoever has his authority shall be included in the request submitted by applicant in accordance with Prime and if the value exceeds 10 million pounds, the approval of the Council of Ministers must be brought. 2. A declaration signed and stamped with the seal of the hospital or medical center (with the signature being validated for non-governmental facilities) providing that the imported device is not for sale or trade and that it is under their full responsibility without any responsibility on the part of EDA. 3. The license of the hospital or Medical Centre issued by department of non-governmental curative institutions &licenses, as well as the basic activity list for associations and civil society institutions. 8.8.2 In the event that a hospital imports, the following are required: 1. A declaration signed and stamped with the seal of the hospital or medical centre (with the signature being validated for non-governmental facilities) providing that the imported device is not for sale or trade and that it is under their full responsibility without any responsibility on the part of EDA. 2. The license of the hospital or medical centre issued by department of non-governmental curative institutions &licenses, as well as the basic activity list for associations and civil society institutions. 3. The hospital’s commercial register (indicating the import activity or being subject to the Investment Authority Law No. 8 of 1997 or 72 of 2017. - In the event that the commercial register does not state that the hospital is not subject to the Investment Authority Law, submit a letter from the Investment Authority stating that the medical facility is subject to the investment law. If there is no mention of the import activity in the commercial register or if the hospital is not subject to the Investment Authority Law, refer to the Import Committee. 8.8.3 If an individual imports a product for personal use, the following are required: Version number/year:02/2025 1. The item imported from abroad must be suitable for the treatment of the case and must be new and unused. If the imported item is used, the applicant will be notified to apply to the Import Committee. 2. A clear medical report on the case. 3. The imported product must be suitable for home use. If the case is under medical supervision, the treating physician must provide an acknowledgment of full responsibility for the use of the medication and a pledge not to use it for any other cases. 4. A pledge by the patient or one of his first-degree relatives (in the case of an incapacitated patient) that the imported product is not for sale or trade and that its use falls under their full responsibility without any responsibility on the part of EDA. The acknowledgment must be confirmed by one of the methods of proving the authenticity of signature. 8.8.4 In the event that a doctor imports, the following documents are required: 1. Quality certificates necessary for the release of the incoming device according to the classification of the incoming item. 2. The clinic’s license from department of non-governmental curative institutions &licenses, 3. The doctor’s license to practice the profession. 4. The specialized scientific committee’s decision with respect to the device if the device has to be approved by specialized scientific committees. 5. The doctor is not allowed to import sterile products required for use in operating rooms unless there is a license for a hospital or specialized medical centre and a pledge is made by the facility that the import is the responsibility of the facility without any responsibility on the part of EDA. 8.8.5 In the event that a company with an activity related to importing medical devices for a hospital, the following documents are required: 1. A clear medical report on the case for whom the items were imported. 2. A declaration signed and stamped with the seal of the hospital or medical centre (with the signature being validated for non-governmental facilities) providing that the imported device is not for sale or trade and that it is under their full responsibility without any responsibility on the part of EDA. 3. The license of the hospital or medical centre issued by department of non-governmental curative institutions &licenses ,, as well as the basic activity list for associations and civil society institutions 8.8.6 If the device is imported by a company that does not import medical devices, the following documents are required: 1. The company’s commercial register, indicating its activity. 2. A pledge that the import is for use within the facility and not for trade. Version number/year:02/2025 3. A clear manual explaining the purpose of use. Taking into account the following: - The presence of a physician working within the company, - Doctor’s license to practice the profession, - The presence of a clinic within the company. Guidance regarding special import requests • Quality certificates for the medical devices must be submitted. If quality certificates are not available, a pledge must be submitted from the user, whether it is for personal use or for a medical centre or hospital, indicating that they know that there are no quality certificates for the product and that importing the devices is on their responsibility without any responsibility on the part of EDA. • The import of commercial quantities is not permitted in all special import cases. In the event that the imported medical device is subject to registration: - A notification of registration issued by the General Administration for the Registration of Medical Devices shall be submitted. In the event that the notification is not available, the user should provide a pledge indicating whether the product is for personal use or for a medical centre or hospital, and that they know that there is no notification of registration for the product and that the medical device falls on their responsibility without any responsibility on the part of EDA. If the value of the invoice exceeds one million pounds and does not exceed 10 million pounds, or the value exceeds 10 million pounds, the approval of the competent minister or whoever can replace him shall be included in the request submitted by applicant in accordance with Prime Minister’s Decision No. 1818 of 2019 amending the Prime Minister’s Decision No. 869 of 2010 regarding the rules and controls for accepting grants, gifts, and donations from foreign or national entities. Appendix IX Documents required to issue a letter of lack of jurisdiction 1. The mandate issued by the importing company or importing body to the person in charge of dealing with the General Administration of Registration to permit trading, signed and stamped by the company’s manager, with the signature being verified by the bank. 2. In the event that the import is for personal use, the ID card of the importer or of the person authorized by the importing entity or company is required if the import is requested by a specific entity or company. 3. Proforma invoice. 4. The manufacturer’s manual explaining the imported device. 5. The payment receipt is stamped by the Authority and the invoice number is written on it. 6. In the case of a dental laboratory, submit the laboratory license issued by the Ministry of Health. 7. In the case of a local dental factory, submit the industrial register. Version number/year:02/2025 8. Provide the commercial register and tax card if the importer is a company whose activities do not include importing medical devices. 9. A declaration of conformity certificate stamped and signed by the legal manufacturer and validated by the Chamber of Commerce and the Egyptian Embassy, indicating that the imported product is not a medical device. If the DOC does not state the intended use, a clarification letter signed and stamped by the manufacturer shall be submitted, indicating the use of the device. Appendix X Quality and trading certificates required according to classification In accordance with the established rules in the European community Class Certificates Class I non-sterile Declaration of conformity certificate (a statement from the manufacturer of the validity of the certificate) or a free sale certificate. Class I sterile Declaration of conformity certificate (a statement from the manufacturer of the authenticity of the certificate) and a free sale Certificate Class II a 1. Declaration of conformity certificate (a statement from the manufacturer of the validity of the certificate) 2. Free sale certificate 3. CE certificate Class IIb / III from a reference country 1. Declaration of conformity certificate (a statement from the manufacturer of the validity of the certificate) 2. Free sale certificate 3. CE certificate Class IIB / III from a reference country 1. Declaration of conformity certificate for imported models (a statement from the manufacturer of the validity of the certificate) 2. Free sale certificate 3. CE certificate 4. In the event of presenting the device to a scientific committee, attach the approval of the specialized scientific committee ISO13485:2016 certificate In accordance with the established rules in the USA, based on what is stated in FDA: Class Certificates Class I 1. CFG certificate Version number/year:02/2025 2. Letter of declaration certificate stating the classification according to the American rules Class II, and III 1. CFG certificate 2. Letter of declaration certificate stating the classification according to the American rules In accordance with the established rules in Canada: Class Certificates Class I 1.DOC acc. To Canadian regulation mentioning the classification According to the rules published on Health Canada website https://www.canada.ca/en/health-canada/services/drugs-health-products/medical- devices/application-information/forms/declaration-conformity-forms-medical- devices.html 2.Manufacturer certificate to cover export of medical devices (= FSC) issued from: the HPFBI, Health Canada 3. Medical device establishment license Class II, III, IV 1.Medical device active license (In case medical device active license is issued for medical device family, medical device group, or medical device group family) Ensure it is still valid through the link: Active license data base https://health-products.canada.ca/mdall-limh/prepareSearch- preparerRecherche.do;jsessionid=2243EC9EFE11F2466DD71F7934514E89?type =active Archived license data base https://health-products.canada.ca/mdall-limh/prepareSearch preparerRecherche.do;jsessionid=2243EC9EFE11F2466DD71F7934514E89?type =archived_archive Version number/year:02/2025 N.B: the declaration letter will be sent to the health Canada to confirm that the license covers the whole medical device list 2.Declaration of conformity acc. To Canadian regulation mention the classification 3.Manufacturer certificate to cover export of medical devices (= free sale) issued from: the HPFBI, Health Canada 4. MDSAP https://www.fda.gov/media/131149/download The above certificates should include the following data: Certificate Issued by Including ● statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer ● Name of the legal and actual manufacturers (if present) ● full address of the legal and actual manufacturers (if present) ● Trade name of the medical device ● medical device description ● Variants either: Codes, models, sizes, references, manual number.... ● Classification in accordance with the rules set out in Annex IX in MDD or Annex VIII of the EUMDR ● Complying with Medical Device Directive 93/42/EEC or EUMDR 2017/745 ● Name and identification number of the notified body. (If applicable) ● CE no. (if applicable) ● Intended use. If not stated, it can be submitted in a separate clarification letter. ● Place and date of issue of the declaration, name and function of Legal manufacturer (D.O.C) Declaration of conformity signed and stamped Version number/year:02/2025 the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature. ● Name of the legal and actual manufacturers (if present) ● full address of the legal and actual manufacturers (if present) ● trade name of the medical device ● medical device description ● Variants either: Codes, models, sizes, references, manual number.... ● Certificate No ● Issuance date ● Validity ● Stating the manufacturer's compliance with current good manufacturing practice requirements for the product. or submitting CFG Without GMP+ISO13485:2016 (USFDA) The US Food and Drug Administration (CFG) certificate to foreign government Signed ● Name of the legal and actual manufacturers (if present) where applicable ● full address of the legal and actual manufacturers (if present) where applicable ● trade name of the medical device ● medical device description (if present) ● Variants either: Codes, models, sizes, references, manual number...... ● Issuance date ● Certificate No. (if present) ● Validity (if present) ● Complying with Medical Device Directive 93/42/EEC or EUMDR 2017/745 Control authority in country of issuance Free sale certificate signed ● Name of the legal and actual manufacturers (if present) ● full address of the legal and actual manufacturers (if present) ● trade name of the medical device (in case of EC –Type Examination or EC Design Examination) CE signed final product Class I Sterile: CE (Annex V or Annex II.3) Version number/year:02/2025 ● Variants ((in case of EC –Type Examination or EC Design Examination)) either: Codes, models, sizes, references, manual number....... ● Certificate No ● Issuance date ● Validity ● Scope of certificate (category/family for submitted products) Accredited Notified body note: list of Accredited Notified body is found on the NANDO website https://ec.europa.eu/erowth/tools- databases/nando/ Class IIa: CE (Annex V or Annex II.3) Class IIb: CE Annex II.3 or CE Annex V + CE Annex III Class III: CE Annex II Section 3 + CE Annex II Section 4 or CE Annex III + CE Annex V ● Name of the actual manufacturer ● full address of the actual manufacturer ● Certificate No. ● Scope of certificate mentioning production, /manufacture of medical devices ● Issuance date ● validity Certification body with accreditation recognized by IAF note: list of accreditation Bodies https://iaf.nu/en/accreditation- bodies/ ISO 13485:2016 signed (Quality management system of the manufacturer) - It is not required to validate quality certificates for medical devices (CFG, Free Sale, CE, ISO13485:2016) issued by reference countries (the Chamber of Commerce and the Egyptian Embassy in the country of origin) and whose authenticity has been verified by the Administration from the authorities that issue these certificates. - In the event that these certificates are not validated by these authorities, these certificates must be validated by the Chamber of Commerce and the Egyptian Embassy. - If the entity does not respond within 3 (three) months from the date of receiving the file, the file will be transferred for safekeeping and resubmitted after documentation again according to the list of documents announced at the time of resubmission. - CFG from USFDA certificates are not required to be validated by the Chamber of Commerce and the Egyptian Embassy in the event that the required data mentioned in them is verified on the website of: - FDA CDRH export certificate validation and Premarket Notification for medical devices classified as Class II - FDA CDRH Export certificate validation and PMA (Premarket Approval) for medical devices classified as class III