Question 1

What is the EDA and why is it important for medical device manufacturers?

Accepted Answer

The Egyptian Drug Authority (EDA) is Egypt's national regulatory body responsible for pharmaceutical products and medical devices, formerly part of the Ministry of Health and Population. The EDA's Central Administration of Medical Devices oversees device registration, quality standards compliance, market surveillance, and post-market vigilance. All medical devices marketed in Egypt must be registered with the EDA, and foreign manufacturers must designate a local Egyptian agent. The EDA has been working to modernize regulations and align with international standards.

Question 2

What are the main medical device registration requirements in Egypt?

Accepted Answer

EDA Registration: All medical devices must be registered before market entry, Egyptian Agent: Foreign manufacturers must designate a local agent licensed by EDA, Quality System Certificate: ISO 13485 or equivalent QMS certification required, Conformity Certificate: CE marking, FDA clearance, or other recognized international certifications, Technical Documentation: Device description, intended use, classification, certificates of conformity and quality, labeling and instructions for use (Arabic language), Free Sale Certificate: Certificate from country of origin confirming device is freely marketed. Registration timelines vary from 3-12 months depending on device class and completeness of documentation.

Question 3

How does Egypt classify medical devices?

Accepted Answer

Egypt uses a risk-based classification system aligned with international standards: Class A: Low risk devices (minimal contact, non-invasive), Class B: Medium risk devices (short-term invasive or diagnostic), Class C: Medium-high risk devices (long-term invasive or therapeutic), Class D: High risk devices (life-sustaining, implantable, critical therapeutic). Classification is based on factors including: invasiveness, duration of contact, whether device is active, intended purpose and therapeutic effect. Higher class devices face more stringent registration requirements and longer review timelines.

Question 4

What is an Egyptian Agent and what are their responsibilities?

Accepted Answer

An Egyptian Agent (also called Local Agent or Authorized Representative) is a person or company established in Egypt and licensed by the EDA to represent a foreign medical device manufacturer. Requirements: Must be domiciled in Egypt with valid business registration, hold EDA license to act as medical device agent, Responsibilities: Submit device registration applications to EDA, maintain technical documentation and certificates, serve as liaison between manufacturer and EDA, handle post-market surveillance and adverse event reporting, coordinate product recalls and corrective actions, ensure compliance with Egyptian labeling and language requirements. An Egyptian Agent is mandatory for all foreign manufacturers marketing devices in Egypt.

Question 5

What quality system certifications does Egypt accept?

Accepted Answer

The EDA requires evidence of quality management system compliance for medical device registration. Accepted Certifications: ISO 13485 certification (most common), FDA QSR compliance (with certificate), MDSAP audit reports, other internationally recognized QMS standards. Certificate Requirements: Must be current and valid, issued by accredited certification body, cover the specific manufacturing site(s), include the device(s) being registered. Note: ISO 13485 is the most widely recognized and recommended for Egyptian market access. Manufacturers without ISO 13485 should obtain certification before pursuing EDA registration.

Question 6

What are the labeling and language requirements in Egypt?

Accepted Answer

Egypt has specific requirements for medical device labeling and documentation: Arabic Language: Labels and instructions for use must include Arabic text, Bilingual Approach: English/Arabic or original language/Arabic combinations are common, Required Information: Device name and model, manufacturer and Egyptian Agent details, intended use, classification, batch/lot and serial numbers, manufacturing and expiration dates, storage conditions, warnings and contraindications in Arabic, Free Sale Certificate: Must be translated to Arabic by authorized translator. Practical Approach: Many manufacturers use Arabic label overlays or insert translations to avoid separate production, but EDA may require Arabic on primary packaging depending on device type.

Question 7

How often is Egyptian regulatory news updated and how can I stay informed?

Accepted Answer

The EDA periodically issues ministerial decrees, guidance documents, and procedural updates that affect medical device registration and compliance. Recent years have seen modernization efforts and increased alignment with international standards. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Pacific Bridge Medical, and Citeline. We recommend checking this page regularly and working closely with your Egyptian Agent to monitor EDA announcements and procedural changes.

Question 8

What commercial sources does this platform use for Egypt news?

Accepted Answer

We aggregate Egyptian regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic EDA announcements, helping you navigate device registration, Egyptian Agent selection, quality certification, and Arabic labeling requirements for successful market entry.

Egypt EDA Medical Device News 2025: Registration & Regulatory Updates | Pure Global

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