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

1. Introduction

This guideline is concerned with the regulatory procedures of registering imported and local medical devices that have international quality certificates.

2. Definitions

Medical Devices: Any instrument, apparatus, appliance, tool, application software, implant, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, • devices for the control or support of conception • products specifically intended for the cleaning, disinfection or sterilization of devices • Provided that it does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Imported Medical Devices: Devices which are completely manufactured abroad and imported to be sold and placed on the market within the Arab Republic of Egypt. Locally manufactured Medical Devices: Devices which are manufactured in sites/facilities inside the Arab Republic of Egypt. Registration applicant: It refers to an importing company, local facility or scientific office. Representative of the registration applicant: He is the representative delegated by the registration applicant to follow up all the works within the Department of Registration. A Non-sterile Medical Device: It is the medical device that is not subject to sterilization process after manufacturing and used in its non-sterile state or require to be sterilized by the user before use. Importing company: It is the first entity in the supply chain that imports medical devices manufactured abroad into the Arab Republic of Egypt. Normal Track Registration System: It is the pathway through which the the review for a variation in a registered medical device license is conducted according to the waiting list of the administration of medical device variations. Fast Track Registration System: It is the pathway through which the review for a variation in a registered medical device license takes priority without being bound by the waiting list of the. administration of medical device variations. F-Toll Manufacturing: * Factory: It is the actual manufacturer of the medical device, which: - is licensed by the competent authority in accordance with applied rules. - holds CE & ISO 13485: 2016 certificates issued by an internationally accredited certification body. Version number/year:02/2025 - The availability of a production line in the factory license • Registration License Holder or “License Holder”: It is the factory applying for registration of a medical device which will be manufactured by another factory which is: - A licensed factory in accordance with applied rules (factory of medical devices or medicine). - A factory that holds CE & ISO 13485: 2016 certificates issued by an internationally accredited certification body that covers the actual place of manufacturing. - A factory that is legally responsible for the medical device. - A factory that, at the present time, does not have a production line for the medical device for which a registration application has been submitted, or that has the production line but its production capacity is less than actually required production. • Legal manufacturer: It is the entity responsible for designing, manufacturing, packaging and labeling the medical device before placing it on the market under its own name, regardless of whether these operations were carried out by this entity himself or on his behalf or by a third party. The legal manufacturer shall be responsible for the quality of the product. • Actual manufacturer: It is the entity where the medical device is in fact manufactured, and packed on behalf of the legal manufacturer List of Reference Countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland Ireland, Italy, Japan, Latvia, Lithuania, Lichtenstein, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom and United States of America

3. Relevant Regulatory Guidelines

- Guideline of technical requirements for medical devices’ factories - Regulatory Guideline for the Regulating Procedures for Registering Imported and Local Medical Devices that Have International Quality Certificates. - Regulatory Guidelines for the Medical Device Vigilance System. Version number/year:02/2025

4. Regulatory Procedures and Rules

4.1 Registration of sterile devices with international certificates

that have international quality certificates. Flow Chart (1) of Registration of Medical Devices 3 or 5 working days Rejected Accepted 7 /20 working days Requirements fulfilled within 60 working days by the company Fulfill Requirements Reject Suspend Accept Requirements Sent by E-Mail to the Company File checking acc. To the check list Final file Revision Evaluation by Technical Committee or central administration Issue Registration License Submission of petition File evaluation Evaluation by: 1-Scientific committee 2-more Regulatory evaluation Electronic submission on the following link medevice.edaegypt.gov.eg Fulfill requirements Evaluated by: 1-Scientific committee 2-Vigilance department 3-Stability committee 4-Regulatory evaluation- (Technical file review, certificate checking) Version number/year:02/2025 Version number/year:02/2025 4.1.1 Procedures of receiving medical devices registration files: 1. A pharmacist from evaluation and assessment administration meets the registration applicant's representative to add the name of the medical device on the payment receipt of the fees and to specify the concerned department (local - imported). The fees of a medical device registration application shall be collected as per the fee category contained in the executive regulations of the law of establishing the Egyptian Drug Authority “promulgated by Prime Minister’s Resolution No. 777 of 2020” and the service fees shall be collected as per the decree issued by the Chairman of the Egyptian Drug Authority in this regard. 2. The company should apply on the electronic platform at the following link: medevice.edaegypt.gov.eg 3. The company will receive a response through the platform within 5 working days from the date of submitting a normal track request and 3 working days for the fast-track request with acceptance/rejection/or suspending the request until meeting the requirements • If the file is accepted: the request is directed to the reviewer pharmacist and the unit head for studying, reporting and sending the requirements for the company for completion • In case of suspension of the request until meeting the requirements: the file is suspended if any of the documents does not meet the requirements according to the published checklist for a period of 90 working days at most, after which the request shall be considered as cancelled When the company meets the necessary requirements, the request will be completed on the platform with the same request number previously acquired • In case of refusing the application: In case of Rejection of the request: the request is rejected if any of the device’s data in the company’s request mismatch with the payment receipt or the required documents or if the request does not concern the addressed department. 4.1.2 Procedures of evaluating a medical device’s registration file • The file is reviewed and requirements are sent on the platform within 20 working days from the date of accepting a normal track file and 7 working days for fast-track files - Procedures of medical devices safety shall be adhered to as it is mentioned in detail in Section 8. 4.1.3 Procedures of completing a medical device’s registration file - Fulfilled documents required for the registration file shall be sent through the platform medevice.edaegypt.gov.eg. The following items shall be adhered to regarding documents uploaded on the electronic platform by the companies: - Documents must be original. - Documents must be stamped with the company’s official stamp. - Documents must be Signed by its legal representative. - Documents may be sent either through scanning and uploading them or using an electronic signature Note: Other electronic documents shall not be accepted. Version number/year:02/2025

4.2 Registration of non-sterile devices with international certificates

devices that have international quality certificates.

4.2.1 Registering non-sterile imported devices (Class IIa, IIb, III)

In case a complete registration file is available in accordance with the checklist (Appendix 1). The same steps and rules mentioned in paragraph 4.1 shall be followed as shown in workflow no.1. In case only an initial registration file is available , which means a complete registration file is not available in accordance with the checklist (Appendix 1). The following procedures shall be followed as shown in workflow no. 2 The registration applicant shall, in parallel, submit an initial registration file on the following link: md.nonsterilereg@edaegypt.gov.eg, which contains a copy of the certificates submitted to the General Administration of trading allowance for each medical device. The following documents are sufficient for the initial registration file: - Declaration of conformity - CE certificate - ISO 13485:2016 - Free sale certificate from a reference country in case of devices classified as Class II b, III. - Free sale certificate from the country of origin in case of devices classified as Class II a. * In the initial registration file: - For devices classified as Class IIa: It is sufficient to submit a free sale certificate from a non- reference country in case a free sale certificate is not available from one of the reference countries, provided that a free sale certificate from one of the reference countries shall be submitted within the grace period of (6 months). - In case the ISO 13485:2016 certificate is not available for all medical devices with various classifications, the file shall be received temporarily, provided that it shall be submitted within the grace period of six months. - In case any of the items mentioned in the invoice submitted in the application for obtaining an importing approval is considered as a part of a group of non-sterile devices, a registration file of all the items of the group shall be submitted in the same initial registration file. Action Steps: 1. Temporary acceptance numbers shall be granted by the Registration Department based on the submitted request and the attached certificates. 2. An importation approval will be issued after obtaining the temporary acceptance number through the Registration Department. 3. Companies shall be granted a period of 18 months from the date of accepting the initial registration file so that they complete the remainder of the registration file, provided that the first six months shall be devoted to complete the main documents of the registration file in accordance with Appendix 1. - During the first 6 months, the company shall submit the registration file in accordance with Appendix 1 at the following link: medevice.edaegypt.gov.eg Version number/year:02/2025 - The company shall then be given a final acceptance number, will be granted a one-year grace period for importation until the registration procedures are completed, as followed in item 4.1. 4-The consent/approval of issuing any importing approval will not be provided after the expiry of the previously mentioned period without completing the required documents in accordance with the checklist (Appendix 1). NB: • In case of repeated importation of the same item submitted for registration in more than one importing approval, the company shall use the same temporary acceptance number without being referred to the Registration Department to prove this. • The registration applicant is permitted to submit an initial registration file without being required to apply for an importing approval. Version number/year:02/2025 Flow Chart (2) of Registration for Medical Devices Class IIa, IIb, III 6 months Evaluation of the file according to check list The company will have a temporary acceptance number The company submits a registration file similar to that submitted for importation department The company will be given a permanent acceptance number Then as per workflow no.1 File evaluation Completion of the registration file according to check list Reject Accept Version number/year:02/2025

4.2.2 Registering non-sterile local devices (Class IIa, IIb, III)

Factories will be given a period of two years for reconciliation of their situations from the date of the issuance of the guideline to complete registration procedures. - During the period of reconciling their situations, trading will be under the responsibility of the factories, as the situation/practice before the issuance of the guideline. - provided that an initial registration file must be submitted during the first 6 month, The following documents are sufficient for the initial registration file: - Declaration of conformity - CE certificate - ISO 13485:2016 - Free sale certificate from a reference country (if available). Action Steps: 1- Temporary acceptance numbers shall be granted by the Registration Department based on the submitted request and the attached certificates. 2- Companies shall be granted a period of 18 months from the date of accepting the initial registration file so that they complete the remainder of the registration file, provided that the first six months shall be devoted to complete the main documents of the registration file in accordance with Appendix 2. - During the first 6 months, the company shall submit the registration file in accordance with Appendix 2 at the following link: medevice.edaegypt.gov.eg - The company shall then be given a final acceptance number, and will be granted a one-year grace period for importation until the registration procedures are completed, as followed in item 4.1. No permission shall be given for importing production raw materials, components and inputs after the end of the granted period. Version number/year:02/2025 Flow Chart (3) of Registration for Medical Devices Class IIa, IIb, III 6 months The company submits a primary registration file The company will have a temporary acceptance number Completion of the registration file according to check list Evaluation of the file according to check list The company will be given a permanent acceptance number Then as per workflow no.1 File evaluation Version number/year:02/2025

4.2.3 Registering non-sterile devices as a system

A group of non-sterile medical devices must be considered as a system and be registered with a single registration number in the following cases: A. The non-sterile medical devices must have the same legal manufacturer. B. One of the certificates (free sale, CE certificate, CFG certificate from USFDA, declaration of conformity) must state that the provided medical devices are a system. C. presentation to the specialized scientific committee to ensure that all items work complementary to one another to form a system. It is not required that the non-sterile medical devices share the following: raw material-GMDN-patient population.

4.2.4 Registering non-sterile devices using the bundling system

The bundling system can be applied to the registration of the non-sterile medical devices in case that the devices share the following: A. Same legal manufacturer B. Same classification. C. Same generic proprietary name. D. Common intended use. E. Similar or close design. F. Be within scope of the permissible variants that may be evaluated by scientific committee. It is not required that the non-sterile medical devices share the following: raw material- GMDN-patient population. Version number/year:02/2025

5. Specialized scientific committees

Flow Chart (4) of Scientific Committee for Medical Devices Scientific committees are divided into different specializations and presentation to one of them is held based on the purpose of use of the medical device or equipment to be presented. Devices that are subjected to specialized scientific committees' evaluation as a step prior to registration are: • Devices submitted for new registration or re-registration, which are imported from non-reference countries or locally manufactured. • Devices submitted for new registration or re-registration, presented to the committee for it to express its opinion on whether the differences between the medical devices are substantial so the medical devices should be registered separately or not. • Medical devices in a dosage form to evaluate the following points: - Safety & effectiveness - OTC or Prescription Claims on label and intended use in IFU • Devices submitted for new registration or re-registration, which their safety reports issued by the medical device’s safety unit recommend the presentation to the scientific committee to evaluate and express their opinion on the safety report or the evaluation of their reports issued by the medical device’s safety unit requires the presentation to the scientific committee. Fulfilling missing requirements and Represent to Scientific Committee. Suspended Finalizing and fulfilling all remaining registration requirements for Registration / Variation License issuance. Present to the Technical Committee. NO YES Committee Decision Scheduling Committee Date Assessment and evaluation of Safety and Efficacy by the committee Version number/year:02/2025 • Medical devices presented to the scientific committee to clarify some technical points. Action Steps: - Transferring the topics that require the presentation to the specialized committee of medical devices registration / the Central Administration of Medical Devices to take the necessary action. - Convening the committee and presenting the topics in addition to the samples to the members for study and expressing the scientific opinion. - Issuing the final decisions on each topic presented (approval/reasoned reasonable suspension/ reasonable rejection). - In case of suspension, the requirements shall be fulfilled through the platform medevice.edaegypt.gov.eg, then the topic will be re-presented to the scientific committee. * The following should be taken into account for the following medical devices: Medical device name / category Prerequisites Anesthesia Infusion, I.V. Set &Administration Set -Must have safety rubber, Injection Port or Latex. -Must have a needle. Can be with or without vent - Must be not less than 110 cm in length. - The package must have a place designated for easy opening. Infusion Sets with Burette Infusion set with burette must contain safety rubber CVC (Central Venous Catheter not peripheral / central Line Catheter / Infusion Catheter) - Need to have guiding syringe (guiding Y-connector) (a passage or a side hole in the needle for guide wire entrance- perforated syringe- double injection needle) Suction catheters - Need to be without any side holes so as not to obstruct suction procedure. I.V Cannula - Must have side pore (injection port) for drug injection unless for sizes 24 and 26 as they are used for neonates and children. - Sample from each cannula size has to be presented to the scientific committee. Extension Lines - Have to state whether Venous or Arterial Breathing Circuit, Oxygen Mask &Nebulizer - Can be Sterile or Non-Sterile but has to be stated on packaging. disposable anesthesia breathings circuits The disposable anesthesia breathings circuits must include all the necessary parts for their use in the following: * In case of the y circuit, the following parts must be present: (Water trap + breathing bag + 3rd limb + CO2 extension) * In case of the co axial circuit, the following parts must be present: (Breathing bag+3rd limb+CO2 extension) must be present in one package for the following reasons: - To avoid connection/reconnection risks - to avoid reuse of part Version number/year:02/2025 Endotracheal - Accept CUFFED for all sizes. - Accept UNCUFFED only for sizes up to and including 5mm. (e.g. 3, 4 & 5 mm which are used for pediatrics). - The Cuffed & Uncuffed Tracheostomy Tubes shall be presented to the Ear, Nose and Throat Committee for specialization. Endocrinology Insulin Pen Needles The outer label of the pen needles, which mentions all types of compatible pens that can be used with it, must be presented to the scientific committee, based on ISO 11608-2: 2012, which requires that the names of pens that are used with the needles shall be added to the labels. Insulin syringes Registration of insulin syringe will not be accepted EXCEPT the 1ml (100 I.U) Ear Nose & Throat (E.N.T.) Tracheostomy Tubes Cuffed & Uncuffed Tracheostomy Tubes shall be presented to the Committee of Ear, Nose and Throat not the anesthesia. Registration of uncuffed & cuffed tracheostomy tubes of all sizes shall be accepted for the purposes of their use in ear, nose and throat surgeries, which are completely different from their use by intensive care physicians. Ear products class I non sterile Inquiry requests shall be submitted by the importing companies, including the following: - Soft and hard copy of: Trade name, Class, Product category, Manufacturer name, country of origin, Intended Use, Composition, Mechanism of action, packaging, labeling and instructions for use The following procedure will be implemented: - Presentation to the pharmacology committee to evaluate whether or not. The product has a pharmacological effect In case the product has no pharmacological effect, it is presented to the specialized scientific committee of Ear, Nose and Throat diseases and surgery to evaluate it Considering it is in a dosage form And receiving the registration file of the device is permitted in case of the approval by the scientific committee/scientific committee approval and the notification of the specialized committee of medical devices registration In case the product has a pharmacological effect, it is presented to the specialized committee of medical devices registration. Version number/year:02/2025 Nasal dosage form class I non sterile Inquiry requests shall be submitted by the importing companies, including the following: - Soft and hard copy of: Trade name, Class, Product category, Manufacturer name, country of origin, Intended Use, Composition, Mechanism of action, packaging, labeling and instructions for use The following procedure will be implemented: - Presentation to the pharmacology committee to evaluate whether or not the product has a pharmacological effect, in case the product has no pharmacological effect, it is presented to the specialized scientific committee to evaluate it Considering it is in a dosage form . And receiving the registration file of the device is permitted in case of the approval by the scientific committee approval and the notification of the specialized committee of medical devices registration In case the product has a pharmacological effect, it is presented to the specialized committee of medical devices registration Hematology Transfusion Set Standard filter mesh size ranges from 170-200μ and has to be mentioned on the package. Apheresis Kit Mention the following statement on the outer label (sales unit) in addition to the internal leaflet of all the Apheresis Kit regarding the period during which the kit will be used: «To be used within (.......) after opening the primary package» Syringes - Companies must describe the age stages on the outer package of syringes with their scientific name, where the word 'neonates’, should be used instead of 'baby' for the age group 0-28 days, based on the World Health Organization’s definition of age groups. - For the syringes going to be registered Samples should be brought from all different age groups (Pediatric, Adults, etc.). Interventional & Diagnostic Radiation Core Biopsy Needles To be presented to the Committee of Interventional and Diagnostic Radiology Angiographic Catheter It is necessary to specify whether it is compatible with lipiodol or not on the device package in the case of locally manufactured devices, or to mention that in the IFU or labels in the case of imported devices. Urology Any product presented for Re- Registration Safety reports shall be brought from the places which the device was supplied to in the last three years. IIb, III & Implantable Medical Devices presented for New Registration Any of the following shall be brought: Long-term Scientific Papers on Safety & Efficacy & Clinical Trials published in reputable journals. It is preferable to bring a summary of market history that the committee takes it into account (places where the device was previously used) in reference countries, although this record is not obligatory. Or the product is be produced by an international company with a good reputation in the international market. Version number/year:02/2025 Urine Collection Bags It must be stated and clearly identified on the package whether it is sterile or not, and the two categories shall be differentiated by color Surgery Surgical Sutures Regarding Surgical sutures: - Those imported from non-reference countries: - A tensile strength test shall be done for one size of each surgical suture before and after registration (new registration / re-registration), and this test is required to be proven in the reports received from the Central Administration for Drug Control in addition to other tests carried out by the Central Administration for Drug Control, provided that the reports received during the course of registration procedures shall be presented to the specialized scientific committee of General and Plastic Surgery. - Those imported from reference countries - regarding the surgical sutures submitted for registration (new registration / re-registration), this test shall be done on them after registration for only one size of the type of the surgical suture subjected to registration and this test is required to be proven in the reports received from the Central Administration for Drug Control in addition to other tests carried out by the Central Administration for Drug Control. Dermal Fillers * The following warning shall be placed in a clear place on the outer package of all Dermal Fillers 1- It is forbidden to inject the device into blood vessels. 2- This device is used by licensed physicians only. * Recommendations issued by the specialized scientific committee of General and Plastic Surgery for Dermal Fillers shall be applied regarding the following: - The ID of the device shall be added inside the package, which determines the batch number so that the treating physician can track and identify the device used for the patient in case of any complications. Where the companies importing the dermal fillers are obligated to keep batches records that have been distributed to supplying places, this record should include all user’s data in accordance with the tracking system (recall system) of each company, so that the Central Administration for Inspection on pharmaceutical Institutions can follow them up. - In case it is mentioned that the Dermal filler has a corrective action in the internal leaflet, it is required to bring scientific studies published in reliable international scientific journals to prove and clarify the corrective action. Version number/year:02/2025 Sterile Dressings The statement (All dressings shall be used under medical supervision) shall be added to the sales unit of the sterile dressings, provided that the implementation of this decision shall be monitored through the Central Administration for Inspection on pharmaceutical Institutions. Stainless steel Sutures Stainless Steel Suture is used only in STERNUM. It is not permitted to mention the following use in the indications of use: Abdominal Wound Closure, Intestinal Anastomosis & Hernia Repair 2 Rows Staplers New registration /re-registration files are received for Open surgery, Linear or Articulating 2 double staggered rows staplers + their reloading units. It is required to present them to the specialized scientific committee for general and plastic surgery, whether these devices are imported from reference or non-referential countries, so that the committee shall express a scientific opinion thereon, and in case the scientific committee approves them, the registration procedures shall be proceeded. - It is required to determine the situation of the reloading units specialized for the staplers before presenting them to the scientific committee. - It is required to determine whether the staplers are used in endoscopic surgeries or open surgeries before presenting them to the scientific committee. - It is required to determine whether the staplers are skin staplers or not by the company on the company's documents before presenting them to the scientific committee Orthopedics Implantable Sterile Medical Products 1- The Free Sale, CE & ISO 13485 certificates shall be presented along with submitting summary of market history from a reference country, as well as submitting Long-Term Scientific Papers on Safety & Efficacy & Clinical Trials Published in Reputable Journals. 2- Tests done on the devices to be registered should be brought from one of the laboratories accredited by the International Laboratory Accreditation Cooperation (ILAC) - In addition, tests shall be done in any of the Faculties of Engineering and shall be evaluated by the scientific committee. Version number/year:02/2025 Implantable Non-Sterile Medical Products - Tests (as per the manufacturing specifications) done on the devices to be registered should be brought from one of the laboratories accredited by the International Laboratory Accreditation Cooperation (ILAC) - In addition, tests shall be done in any of the Faculties of Engineering and shall be evaluated by the scientific committee. Medical devices that have a legal manufacturer in a reference country and an actual manufacturer in a non-reference country shall be exempted from submitting the following: - summary of Market history from a reference country along with submitting Long-Term Scientific Papers on Safety & Efficacy & Clinical Trials Published in Reputable Journals - Tests on the devices to be registered shall be done in one of the laboratories accredited by the International Laboratory Accreditation Cooperation (ILAC) and shall be evaluated by the scientific committee. - Tests of the Faculties of Engineering. Ophthalmic Sutures from Non -Reference country -A tensile strength test shall be done for all sizes of Ophthalmic Sutures before and after registration (new registration /re- registration), and this test is required to be proven in the reports received from the Central Administration for Drug Control in addition to other tests carried out by the Central Administration for Drug Control, provided that they shall be presented to the specialized scientific committee of ophthalmology and eye surgery. Trypan blue Registration files can be received for devices containing TRYPAN BLUE at a concentration not exceeding 0.06% and devices whose indications of use are for the surgeries of cataract and the anterior segment of the eye. Ectoin New registration /re-registration files containing Ectoin will not be received. Cardiology Silk Suture without needles Silk Suture without needles can be received since it is used by specialists in the field of cardiovascular surgery in many fields, including but not limited to, in ligation of tubes during surgical operations. Version number/year:02/2025 Other devices Oral dosage form class I non sterile Inquiry requests shall be submitted by the importing companies, including the following: - Soft and hard copy of: Trade name, Class, Product category, Manufacturer name, country of origin, Intended Use, Composition, Mechanism of action, packaging, labeling and instructions for use The following procedure will be implemented: - Presentation to the pharmacology committee to evaluate whether or not the product has a pharmacological effect in case the product has no pharmacological effect, it is presented to the specialized scientific committee to evaluate it Considering it is in a dosage form And receiving the registration file of the device is permitted in case of the approval by the scientific committee approval and the notification of the specialized committee of medical devices registration In case the product has a pharmacological effect, it is presented to the specialized committee of medical devices registration Obesity products Inquiries requests shall be submitted by the companies’ importing devices that are used to treat obesity and that are classified as a medical device in their country of origin, and they will be presented to the competent specialized committees before deciding. It’s registration situation. Version number/year:02/2025

6. Stability and biocompatibility studies committee

biocompatibility studies. Flow Chart (5) of Stability Committee for Medical Devices Fulfill requirements Requirements fulfilled requirements not fulfilled Reject Accept Evaluation by the Stability committee Archived (minutes of meeting & files (soft copy) File revision by junior pharmacist (within 5 working days) then by senior pharmacist (within 5 working days) The Requirements sent to the company via MeDevice platform Revision by junior pharmacist (within 5 working days) Electronic submission of stability files The company submits requirements Committee requirements: the company is informed by senior to fulfill these requirements (after approving the minutes of the session) Accept: registration team is informed by senior to continue registration process (after approving the minutes of the session) Final revision by senior pharmacist (within 5workingdays) Version number/year:02/2025 Presentation to the specialized scientific committee of evaluating stability and biocompatibility studies is required in the following cases: 1- Locally manufactured medical devices submitted for registration or re-registration that are not traded in one of the reference countries (i.e., do not have a free sale certificate from one of the reference countries or do not have a 510K (FDA Clearance) certificate). 2- Registered devices that are submitted to the Department of Variations for modification (i.e., changing or adding a package - changing or adding a sterilization method - changing storage conditions). 3- Shelf-life extension of a medical device (re-registration/variations). 4- Registered devices that are submitted to the Department of Variations for correcting the shelf-life period as a result of an error in the shelf-life certificate provided by the company. Action Steps: 1- The file shall be submitted on the platform medevice.edaegypt.gov.eg in accordance with the check list (Appendix 5). 2- The stability file will be accepted if it fulfills all the items mentioned in the check list. 3- The stability file is evaluated within 10 working days. - In case there are some missing requirements, they shall be fulfilled and submitted on the platform medevice.edaegypt.gov.eg, so they will be reviewed and the registration applicant shall receive a response within 5 working days from the date of submission. 4. After fulfilling all requirements, the file shall be presented to the specialized scientific committee of evaluating the stability and biocompatibility studies of the medical devices. 5. In case the committee approve the file, the registration procedures shall be completed, but if some documents are required to be provided, the company shall be notified. Version number/year:02/2025 • General requirements regarding the specialized scientific committee of evaluating stability and biocompatibility studies: First: When the local factories present a stability study of any medical device to be evaluated by the specialized scientific committee of evaluating stability and biocompatibility studies of medical devices, they must submit the following: • Stability studies of locally manufactured medical devices are required to be presented to the specialized scientific committee of evaluating stability and biocompatibility studies and they should be accompanied by samples sealed by the Central Administration for Inspection on pharmaceutical Institutions, and stamped by the entity that conducted the study (the factory/a certified laboratory), provided that this sample shall be kept in the factory throughout the validity period of the registration license of the medical device, this procedure shall be followed up by the Central Administration for Inspection on pharmaceutical Institutions, where the factory is obligated to submit this sample with a lot number identical to the number that was mentioned in the stability study submitted for presentation to the specialized scientific committee of evaluating the stability and biocompatibility studies of medical supplies. This decision shall be applied to stability studies conducted after 2/1/2018 • The seizure record attached to the sample sealed by the Central Administration for Inspection on pharmaceutical Institutions • The checklist template issued by the Central Administration for Inspection on pharmaceutical Institutions which was applied to the factory laboratory in which the stability study was conducted. Second: A real time stability study must be submitted for the medical devices submitted for re-registration. Third: Regarding the storage conditions mentioned on the outer package of locally manufactured medical devices: i. Stability studies conducted at storage conditions of 30 Co±2, RH 65±5% must be submitted as the Arab Republic of Egypt falls within Zone Iva. ii. Regarding the storage conditions mentioned on the internal labels of the medical devices, the manufacturer must place a guiding symbol on the label of the medical device stating that the maximum temperature for storing the medical device is 30 ̊ , or it shall clearly indicate the following statement on the label of the medical device (Upper limit of temperature = 30 ̊). iii. In case the manufacturer desires to place a guiding symbol stating the (upper and lower limits of temperature), the manufacturer must provide evidence of the stability of the medical device at the temperatures mentioned in the guiding symbol. iv. The manufacturer must store the medical device under the storage conditions stated on the internal labels of the medical device and mentioned in the registration license, where the storage of the medical device under those conditions will be followed up by the Central Administration for Inspection on pharmaceutical Institutions Version number/year:02/2025 Fourth: In case the company cannot conduct the stability study or some of the tests, it may conduct the tests in an accredited entity that is approved for this purpose, provided that the company shall submit a qualification/accreditation certificate of the entity issuing the stability study in accordance with the international standard ISO-17025 issued by the accreditation body, along with providing the proof that the scope of accreditation of this entity includes its accreditation to conduct the tests provided. the results of these tests must be under the responsibility of the producing company. In this case the results of these tests can be included as part of the stability study of the product. Fifth: The biocompatibility study must be conducted by an accredited entity that is approved for this purpose, provided that the company shall submit a qualification/accreditation certificate of the entity issuing the study in accordance with the international standard ISO-17025 issued by the accreditation body, along with providing the proof that the scope of accreditation of this entity includes its accreditation to conduct the tests provided. the results of these tests must be under the responsibility of the producing company. Sixth: It is required to identify the sterilization method of the medical device that is being tested in all studies related to Sensitization & Irritation tests Seventh: Medical devices imported from reference countries and submitted to the Department of Variations are exempted from submitting a biocompatibility study when presented to the specialized scientific committee of evaluating stability and biocompatibility studies of the medical devices. Version number/year:02/2025

7. Committee for registering medical devices

Flow Chart (6) of specialized committee on registration of medical devices Refusal suspended Acceptance Uploading regulatory and legislative decisions to official website Assessment of topics by committee members and issuing a decision Fulfillment of requirements 1-Evaluation by scientific committees 2- Evaluation by stability committee 3- Evaluation by medical devices safety department 4- Fulfilling requirements by applicant Start Setting committee date Issue Registration License or supplementary letter (variation) By registration department Submission of petition Informing concerned companies and departments with decisions Informing concerned companies and departments with decisions Version number/year:02/2025

8. Safety of medical devices

A file shall be submitted to the Medical Devices Safety unit in the following cases only: Medical devices classified as class IIb, or III and medical devices classified as class I, IIa with regulatory actions, this is for the following medical devices: - Imported medical devices submitted for registration/re-registration. - locally manufactured medical devices submitted for re-registration. Also, safety declarations should be provided by the manufacturer in the following cases: - Imported medical devices submitted for registration or re-registration and locally manufactured medical devices submitted for re-registration in all their classes. • In case of applying for registration/re-registration, the importing company is obligated to submit a commitment that it has a vigilance system in place for medical devices and that it follows up all its activities and requirements in accordance with the guidelines of the medical devices vigilance system with the Medical Devices Safety Unit- the Egyptian Pharmacovigilance Center. • The company must report any recall, FSN, or FSCA procedures that take place globally, or any incidents being monitored in the Arab Republic of Egypt to the Medical Devices Safety unit the Egyptian Pharmacovigilance Center, in accordance with the time periods specified in the guidelines for the Medical Devices Vigilance System. Forms of Declarations of Safety (Appendix 6)

9. Issuance of registration license

After completing the required documents of the registration file and paying the fees and service consideration, a registration report is issued for the medical device, valid for 10 years

10. Procedures of re-registration

- Re-registration of medical devices shall be every 10 years based on a request submitted to the Central Administration for Medical Devices. Initial acceptance of the request is required to be within the first 3 months of the last year of the registration license validity. - The applicant has to submit the re-registration file in accordance with the check list of the required documents. - Service consideration shall be collected in accordance with the decree issued by the Chairman of the Egyptian Drug Authority in this regard. - For the re-registration of locally manufactured medical devices and medical devices imported from non-reference countries, it is not required for them to be re-evaluated by the scientific committees in case of receiving reports from the Safety Department indicating that the documents have been accepted, and no regulatory actions have taken place for the device, along with the absence of any modification in the registered device in terms of composition - usage - design – classification. Version number/year:02/2025 - For locally manufactured medical devices that are subjected to presentation to the Scientific Committee of evaluating stability studies: o These medical devices shall not be presented to the scientific committee of evaluating stability studies in case that no modification has occurred in the raw materials of the package and in case a real time stability study has been submitted during the registration for the first time or during the period of the registration license validity. o In case a real time stability study is not submitted during the registration for the first time or during the period of the registration license validity, it will be evaluated during re- registration. o In case a change has occurred in the raw materials: the biocompatibility study shall be re- evaluated by the scientific committee of stability. o In case of changing the sterilization method: the following shall be re-evaluated by the scientific committee of evaluating stability studies: New stability study including sterilization validation only and re-revaluation of biological risk assessment. o In case a change has occurred in packaging material or packaging dimension, the following shall be re-evaluated by the scientific committee of evaluating stability studies: New stability study including packaging validation only and re-evaluation of biological risk assessment. o In case of changing the shelf life and/or storage conditions: the following shall be evaluated by the scientific committee of evaluating stability studies: Version number/year:02/2025 New stability study and re-evaluation of biological risk assessment. - The applicant has to complete the re-registration procedures within one year from the date of the expiry of the registration license period, and trading is permitted for him during this year. Upon the expiration of this period, if the requirements of the final file of re-registration are not fulfilled, the request will be considered as cancelled and the Central Administration for Inspection on pharmaceutical Institutions will be notified. The request shall be renewed based on a formal request submitted by the company and repayment of the registration fees. The file shall be re-received and a one-year period will be granted to complete the re-registration requirements.

11. General requirements

1. Medical devices must share the following criteria to be registered as a medical device with a single registration number: Trade name, GMDN or UMDN Code, classification, intended use, manufacturer, Raw materials and age group (except for differences in sizes). Sutures shall not be separated if their Raw materials are different and a single registration license will be granted. • In case the medical devices differ in the abovementioned elements, they will be registered as separate medical devices and each medical device shall be given a separate registration license with a separate registration number. 2. In case the medical devices share the abovementioned elements but vary in any other difference, these devices shall be presented to the specialized scientific committee to study these differences and determine whether or not the differences are considered substantial, and then separating the devices and registering each device separately. 3. Requirements for registering orthopedic devices as a system: • Applied to joints, screws and plates. • The original catalog provided by the shall be attached to the registration file, in order to ensure that the parts intended to be registered as one system are identical with the catalogue, and the producing company shall provide a proof indicating that the parts intended to be registered are parts of one system, based on the decision of the Specialized Scientific Committee of Orthopedic Diseases and Surgery. • Each device submitted for registration shall be presented separately to the Specialized Scientific Committee of Orthopedic Diseases and Surgery. • The medical devices submitted for registration shall be considered as a system based on CE design examination certificate, or certificate of free sale, or the FDA certificate, provided that the parts of each system with their codes shall be clearly stated in certificate of free sale or the FDA certificate. 4. The original registration license belongs to its owner and any copy with another agent/distributor will not be taken into account. 5. It is not permissible to make any deletion or change in the data of the registration license, otherwise it shall be considered as invalid. 6. Medical devices taken through the oral/nasal/auricular route will be analyzed during their registration procedures. Version number/year:02/2025 7. The validity period of the registration license expires ten years from the date of registration, and the initial acceptance of the request is required to be within the first 3 months of the last year of the registration license validity. 8. It is not permitted to advertise medical devices in any media outlet except after obtaining a written approval from the competent administration of the Egyptian Drug Authority. 9. The registration license is issued in accordance with the quality certificate issued for the device. The foreign manufacturer and the importer are fully responsible for the validity and technical safety of the device and any defects or dangers resulting from its use falls under their own responsibility. 10. Registration department shall be dealt with by an official delegation issued for the company’s representative with a bank authentication (valid signature). 11. It is not permissible to make any change in the medical device except after obtaining the approval of the Central Administration for Medical Devices in accordance with the applicable procedures as per the type of change, otherwise the registration license shall be cancelled. 12. Recall system shall be applied. 13. The company must implement safety requirements. Version number/year:02/2025 14. Special requirements for some medical devices The registration of any Textured Breast Implant, whether imported from reference or non-reference countries, is not accepted, because it has been proven to be dangerous globally and it causes large cell lymphoma. Textured Breast Implant Files of registration/proceeding with registration procedures/importation of these devices is not accepted. ` Textured Tissue Expanders Any “Injectable Permanent Soft Tissue Dermal filler” shall not be received, as the incidence of serious complications resulting from its injection is very high, which has led to a consensus by many international scientific studies that it shall not be used due to its danger. Injectable Permanent Soft Tissue Dermal filler Files of new registration/re-registration of any Laparoscopic 2 rows stapler that is used in the digestive system shall not be received. Laparoscopic 2 rows stapler Files of new registration of Surgical Powdered Latex Gloves shall not be received. Surgical Powdered Latex Gloves Files of new registration of any Steel Lancet device shall not be received, because there are more convenient alternatives, less painful, and less susceptible to contamination, and because this steel lancet devise causes a wound that is more serious than that caused by other types, and diabetic patients’ wounds do not heal easily. Steel Lancet This device has no use in modern medicine, and when connected with suture, it requires making a knot, which causes tissue rupture. Surgical needle (A needle without suture) - Files for new registration/re-registration of syringes without needles for intravenous, intramuscular or subcutaneous injection shall not be received. Syringes without needle - No appointments will be given or files receiving No proceeding with registration procedures shall occur for double-graded syringes. - Insulin syringes other than those with 100-unit size Is not permitted. Insulin syringes (Grade 40 or double grade) Version number/year:02/2025

12. Documents required to register medical devices

List of abbreviations

Definition Acronym Premarket Notification 510 K An extra equipment piece specifically manufactured to be used with a medical device Accessory Active implantable medical devices AIMD Accelerated aging of sterile barrier system for medical devices ASTM European Conformity CE or EC Certificate for Foreign Governments CFG Code Of Federal Regulations CFR Declaration of Conformity DOC Egyptian Drug Authority EDA Food & Drug Administration FDA Free Sale Certificate or Certificate of Free Sale FSC or CFS Field Safety Corrective Actions FSCAs Field Safety Notices FSNs Global Medical Device Nomenclature code GMIDN Code Good Manufacturing Practice GMP Instruction For Use IFU International Organization for Standardization ISO In Vitro Diagnostic IVD In Vito Fertilization IVF Medical Device MD Medical Device Regulations MDR (2017/745) Medical Device Documents MEDDEV Ministry of Health MOH Notified Body NB Own Brand Labeling OBL Original Equipment Manufacturer OEM Pre-Market Approval PMA Summary Of Marketing History SMH Unique Device Identification System UDI Universal Medical Device Nomenclature System UMDN Code United States Pharmacopeia USP Version number/year:02/2025

History Table

Summary of changes Issue date Version 22/07/2025 Vesion1 The name of the Central Administration for Operations has been updated to become the Central Administration for Inspection on pharmaceutical institutions or the Central Administration of Licensing of pharmaceutical institutions whenever they are mentioned in the guideline, depending on the specialization. 01/09/2025 Version 2