🇪🇬 Egypt medical device regulatory data

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; the import-approvals guideline restates that devices may not be advertised in any media except after obtaining EDA approval.

Only scientific offices have the right to import samples for the purpose of advertising and marketing medical devices, and such samples must be printed with the statement that they are samples for advertising and not for sale.

After completing the registration file and paying fees, a registration license (registration report) is issued for the medical device valid for 10 years.

Re-registration is every 10 years; initial acceptance of the re-registration request must be within the first 3 months of the last year of the license validity. The applicant may complete re-registration within one year after expiry and trading is permitted during that year; otherwise the request is cancelled, the inspection administration is notified, and renewal requires a new request and fee repayment.

Egyptian Drug Authority (EDA) is the competent authority for medical devices; its Central Administration of Medical Devices (CAMD) runs registration, import approvals and device safety.

The Central Administration of Medical Devices (CAMD) of EDA houses the General Administration of Registration of Medical Devices and the market authorization administration handling device registration, variations and import approvals.

Changes are tiered: 'Do and tell' (applicant name/address, non-significant label changes) - consignments not seized but change must be filed; 'Tell and do' (codes, manufacturing site transfer, shelf-life, sterilization method, manufacturer name, packaging, significant label changes) - consignments not placed on market without an initial acceptance number; 'Tell, assess and then do' (material/substance/component, design, intended use) - marketing suspended while EDA adjudicates whether it is a variation or a new device requiring a new registration file.

Variations are reviewed on a Normal Track (per the administration's waiting list) or Fast Track (priority); the applicant receives a response within 8 working days (normal) or 5 (fast), file review takes 25 working days (normal) or 10 (fast), and a suspension for missing documents lasts at most 90 working days before cancellation. A one-year grace is granted for placing the varied device on the market from acceptance of the variation request; if the applicant does not follow up for 60 working days the file is archived and the request cancelled.

Interventional research in Egypt using new medical devices not previously used in humans and not accredited by international bodies falls under EDA clinical-trial oversight (Law 214/2020). For locally manufactured devices the applicant must first obtain technical-file approval and classification from the Central Administration of Medical Devices before protocol submission; imported devices (with or without international quality certification) proceed directly to protocol submission and evaluation.

IVD medical devices are defined as reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems for in vitro examination of specimens derived from the human body; specimen receptacles are IVDs, while products for general laboratory use are not unless specifically intended for IVD examination.

Egypt defines a medical device as any instrument, apparatus, appliance, tool, application software, implant, material or other article intended for human medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation of disease, etc.) that does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software is explicitly in scope.

The dossier requires a CE certificate of the finished product issued by a notified body (with EU 722/2012 TSE annotation where bovine material is used), an ISO 13485:2016 or EN ISO 13485:2016 certificate from an internationally accredited certification body covering the product category, and a stamped/signed Declaration of Conformity. A CE certificate is not required for Class I non-sterile devices, which instead submit a compliance-with-essential-requirements and harmonized standards checklist.

Uploaded documents must be original, stamped with the company's official stamp and signed by the legal representative (scans or electronic signature accepted); the file includes technical-file contents on manufacturer letterhead (composition, analysis certificate, sterilization certificate, packaging), inner/outer label data with Master Label samples and artwork, the original IFU signed and stamped by the manufacturer, shelf-life certificate, previous license for re-registration, and a device sample.

Foreign certificates from reference countries must be legalized by the Chamber of Commerce and the Egyptian Embassy in the country of origin unless EDA verifies their authenticity directly with the issuing bodies; if the issuing body does not respond within 3 months of file receipt, the file is saved and must be resubmitted with legalization.

For devices imported from non-reference countries in all classes (I, IIa, IIb and III), the applicant must provide clinical trials published in reputable scientific journals and an approved, stamped summary of market history from centers/hospitals in reference countries where the device was used, plus material composition certificate, catalog/leaflet with intended use and inner/outer labels.

The registration applicant is an importing company, a local facility or a scientific office; the importing company is the first entity in the supply chain that imports devices into Egypt. For local devices without international certificates the applicant is the local manufacturer or its scientific office. A foreign manufacturer authorizes the applicant via a letter listing the devices it may register.

Egypt distinguishes the legal manufacturer (responsible for design, manufacture, packaging and labeling before placing on the market under its own name, and responsible for quality) from the actual manufacturer (where the device is in fact manufactured and packed on the legal manufacturer's behalf); both must be identified on certificates. F-toll (contract) manufacturing is permitted under defined license-holder conditions.

Companies may obtain an annual import plan through the Medical Devices Import Plans Unit (application and evaluation each within 3 working days); the plan is valid for one year from issuance and amendments are requested via the platform.

Importing medical devices requires an EDA import approval issued via the MeDevice platform, valid for one year from issuance; a customs release approval per invoice or annual plan is also needed. Newly registered devices are not released until their notification of registration is issued (two transition exceptions, each with one year for release).

Customs release covers registered devices, registration samples, raw material analysis samples, import approvals, annual-plan devices and intragastric balloons; for import approvals and annual plans the company pledges that shipment invoices will not be opened unless an inspector from the Central Administration for Inspection on Pharmaceutical Institutions is present.

The import-approval file must include the medical-device importer's registration licence, added to the supplier or manufacturer based on the relationship letter.

Electronic labeling is accepted: the foreign manufacturer's e-IFU is submitted in the registration file and attached to the registration license, with artwork approved by the legal manufacturer carrying the statement that a printed paper IFU will be provided at the latest within 7 calendar days of a user request.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

Minimum label data: trade name, product name, product code/model/Ref, batch or serial number, special handling and storage precautions, single-use indication where applicable, expiry date (month/year at least), UDI on label or packaging when applied, factory name/address and country of origin, sterilization word/symbol plus method, and the Egyptian importing company's full name and address as recorded in the importers registry.

Because Egypt falls in climate zone IVa, local manufacturers must run stability studies at 30 C +/-2 and RH 65+/-5%, and place a guiding symbol on internal labels stating the maximum storage temperature is 30 C, or clearly state 'Upper limit of temperature = 30' on the label; storage under the labeled conditions is followed up by inspection.

Device rules are issued as EDA Chairman decrees, including No. 429/2021 (registration of devices holding international quality certificates), No. 642/2021 (label data of medical/laboratory devices and diagnostic reagents), No. 469/2021 (variations to registered devices), No. 424/2022 (registration of local devices without international quality certificates), No. 190/2022 and No. 88/2022 (import approvals for medical devices/accessories/spare parts and supplies).

Law No. 214 of 2020 regulates clinical medical research in Egypt; its executive regulation is PM Resolution No. 927 of 2022. EDA's clinical-trial oversight guideline (EDREX.GL.Bioinn.006 v5/2026) must be read with both.

Law No. 151 of 2019 establishes the EDA (with the Unified Procurement Authority); its executive regulations were issued by Prime Minister's Resolution No. 777 of 2020 (29/03/2020), which contains the fee categories for device applications.

UDI requirements for medical devices, accessories and IVDs are set by EDA Chairman Decree No. 499 of 2021, implemented by guideline EDREX:GL.CAMD.005 (v02/2026).

Manufacturers of Class I medical devices (and Class A or equivalent IVDs) must prepare a post-market surveillance report summarizing post-market data analyses with rationale and corrective/preventive actions, updated when necessary and available to the authority on request.

Class IIa, IIb and III devices (and IVD classes B, C, D) require a PSUR with a national appendix; Class IIb/III (IVD C/D) at least annually, Class IIa at least every two years, IVD Class B at least every 3 years, custom-made devices annually or every 2 years per class; other devices provide PSURs on request. PSURs must cover benefit-risk conclusions, PMCF/PMPF findings and sales/usage volume.

Manufacturers, scientific offices, authorized representatives, importers and distributors must appoint an authorized person (safety officer) to communicate with the Medical Devices Safety Unit (MDSU), and must document and implement written procedures for incident follow-up, plus a tracking system recording supply and distribution information for complaints handling.

A trend report (Annex 10) must be made to MDSU on a significant increase in reportable incidents, expected side effects exempt from reporting, or normally non-reportable events that could significantly impact the benefit-risk analysis; methodology and observation period are defined in the PMS plan. EU Commission trend report forms may be used.

Registration, variations, import approvals, annual plans and special import requests are all submitted on the EDA MeDevice platform at medevice.edaegypt.gov.eg; responses, requirements and completions are exchanged through the same platform, with registration replies within 5 working days (normal track) or 3 working days (fast track).

For the international-certificate route, QMS evidence is an ISO 13485:2016 or EN ISO 13485:2016 certificate issued by an internationally accredited certification body covering the product category; an FDA CFG stating cGMP compliance replaces the ISO 13485 certificate. ISO 13485 alone qualifies a local factory for the without-CE route but does not itself issue Egyptian registration; MDSAP reuse is not explicitly provided for.

Local factories must hold approvals from competent industrial authorities and meet CAMD technical requirements for manufacturing sites (site layout, ceiling height, water precautions, generator etc.); factories classified as Class Is, IIa, IIb and III are covered, while Class I non-sterile factories are excluded except devices in pharmaceutical dosage form. No site modification is allowed before EDA request and actual inspection. EDA inspection committees may also travel abroad (Chairman Decree 157/2021).

Where a market-placed device fails to perform per its IFU and the failure might lead to death or serious deterioration, the manufacturer/authorized representative must initiate an FSCA and report it to MDSU in advance (except urgent recalls), notifying all affected countries simultaneously. FSNs must be reported to MDSU within 2-5 days of issuance with an FSCA implementation plan; MDSU issues an approval letter permitting FSN distribution (urgent recalls may distribute first), and periodic implementation reports are required if the FSCA exceeds 90 days.

When a scientific committee issues a one-year decision requiring re-evaluation, the applicant must submit a signed and sealed list of hospitals supplied with the device so that the Medical Devices Safety Department can use questionnaires to verify safety and effectiveness and present the results to the committee.

Non-sterile devices can be registered as a bundle when they share the same legal manufacturer, classification, generic proprietary name, common intended use and similar or close design, within permissible variants; raw material, GMDN and patient population need not match. A group of devices working complementarily can be registered as a system with a single number.

For non-sterile Class IIa, IIb, III devices an initial registration file (Declaration of Conformity, CE certificate, ISO 13485:2016, free sale certificate) can secure a temporary acceptance number and importation approval; companies get 18 months from acceptance to complete the full file, with the first 6 months for the main documents and a one-year import grace after the final acceptance number.

Locally manufactured medical devices of factories holding ISO 13485:2016 but no CE certificate follow guideline EDREX:GL.CAMD.009/010; the factory must apply GMP in accordance with Central Administration of Operations (CAO) procedures, and trading is not permitted until registration procedures are completed.

Imported and local medical devices holding international quality certificates (CE, ISO 13485, FDA CFG etc.) are registered under guideline EDREX:GL.CAMD.002 (v2, effective 09/2025), with separate procedures for sterile devices and for non-sterile Class IIa, IIb and III devices.

Devices are registered under a single registration number only if they share trade name, GMDN or UMDN code, classification, intended use, manufacturer, raw materials and age group (size differences excepted); sutures with different raw materials still get one license.

If a registration file is suspended for missing documents, the company must complete requirements within 90 working days at most, after which the request is cancelled; the same request number is reused when completing. In the evaluation workflow the company must fulfil EDA requirements within 60 working days. Import-approval and variation files follow the same 90-working-day suspension rule (import files: 90 calendar days).

Separate import-approval routes exist for devices used in exhibitions, workshops and training; devices imported for a research protocol; production inputs, components and raw materials for local device factories; and customs release of registration samples. For the exhibition, workshop and training route, failure to complete requested documents within 32 days stops review and causes rejection; 32 days is not the authority's review time.

A Special Import Requests Evaluation Unit handles imports where the device is: a donation for hospitals, imported by a hospital, by individuals for personal use, by a physician, by a company without medical-device import activity, or by a medical-device company for a hospital or patient. Applications go via MeDevice (response in 3 working days); the Import Committee accepts, postpones or rejects with reasons, and approval is valid one year.

Applicants may appeal a Scientific Committee or Import Committee rejection by submitting new documents not previously presented or a scientific explanation of the rejection points.

Requirements are sent to the company by e-mail/platform and must be fulfilled within 60 working days (registration workflow); suspended files are completed on the platform under the same request number, hard-copy submission may be scheduled for variations, and rejected requests state the mismatch grounds (data vs payment receipt/required documents or wrong department).

The manufacturer or its agent must submit and maintain data in the Egyptian UDI Database, validate it during submission and annually, and ensure UDI-DI data is available at the time the device is placed on the market; record updates for changes not requiring a new UDI-DI are due within 10 working days. Data must be in English, with an Arabic trade name for lay/home-use devices, and includes the agent's national registry number and the device's national registration number.

Manufacturers must assign UDI (UDI-DI plus UDI-PI(s)) to devices, accessories and IVDs supplied to the Egyptian market under Chairman Decree 499/2021; GS1 standards apply by default and other IMDRF-designated issuing agencies may be used if the brand owner/agent notifies EDA. Research-use, investigational and custom-made devices are out of scope.

At registration/re-registration the importing company must submit a commitment that it operates a device vigilance system followed up with the Medical Devices Safety Unit of the Egyptian Pharmacovigilance Center, and must report any recall, FSN or FSCA taking place globally or any incident monitored in Egypt. A safety file is required for Class IIb/III and for Class I/IIa with regulatory actions; Class I/IIa (IVD A/B) devices without recalls in the previous three years submit Declaration 1 instead.

Incident reports go to the Medical Devices Safety Unit (MDSU), part of EDA, via the MIR form downloaded from the EDA website and submitted by e-mail (pv.md@edaegypt.gov.eg); the latest EU Commission MIR form is acceptable and IMDRF adverse-event terminology should be used. Follow-up responses to MDSU queries are due within 15 days; investigation final reports within 15 days (no testing), 30 days (testing in Egypt) or 90 days (testing outside Egypt).

Only serious incidents occurring in Egypt are reported to the MDSU, by Manufacturer Initial Report (Annex 7): serious public health threat - immediately, not later than 2 calendar days after the manufacturer establishes the causal relationship; death or unanticipated serious deterioration - not later than 10 calendar days; any other serious incident/near incident - not later than 15 calendar days. Uncertain cases must still be reported within the timeframe.