Medical Device Registration in Ethiopia
Expert guidance for medical device certification and registration with EFDA, ensuring compliance with Ethiopian regulatory requirements.
Overview
Medical device registration in Ethiopia is regulated by the Ethiopian Food and Drug Authority (EFDA), which ensures that all medical devices meet safety, performance, and quality standards before they can be marketed in the country.
YAM BUSINESS specializes in medical device registration, providing comprehensive support for manufacturers seeking to enter the Ethiopian market. Our expertise covers all device classifications, with particular focus on Class B and Class C devices.
Our team guides you through the entire registration process, from device classification and documentation preparation to submission and post-approval compliance, ensuring a smooth and efficient pathway to market.
Medical Device Classification
Understanding the classification of your medical device is crucial for determining the regulatory requirements and registration pathway in Ethiopia.
Examples:
- Bandages
- Examination gloves
- Tongue depressors
- Non-invasive devices
Requirements:
Simplified registration process with basic documentation
Examples:
- Surgical gloves
- Urinary catheters
- Dental fillings
- Contact lenses
Requirements:
Standard registration process with technical documentation
Examples:
- Ventilators
- Dialysis equipment
- Surgical lasers
- Diagnostic imaging devices
Requirements:
Comprehensive registration with detailed technical documentation and clinical data
Examples:
- Implantable devices
- Heart valves
- Pacemakers
- Neurosurgical devices
Requirements:
Stringent registration requirements with extensive clinical evidence and post-market surveillance
Classification Assistance
Unsure about your device's classification? YAM BUSINESS provides expert classification assessment services to determine the appropriate regulatory pathway for your medical device in Ethiopia. Contact us for a free initial classification consultation.
Registration Requirements
Comprehensive documentation is essential for successful medical device registration in Ethiopia. YAM BUSINESS helps you prepare and organize all required documents according to EFDA standards.
- Device description and specifications
- Information on design and manufacturing
- Risk analysis and risk management file
- Verification and validation data
- Pre-clinical and clinical evaluation data
- Labeling and instructions for use
- ISO 13485 certification
- Quality manual and procedures
- Manufacturing process validation
- Design control documentation
- Supplier management procedures
- Post-market surveillance system
- Application form
- Authorization letter for local representative
- Declaration of conformity
- Certificates from regulatory authorities
- Business license of local representative
- Registration fee payment receipt
Registration Process
Our streamlined approach to medical device registration in Ethiopia ensures efficient processing while maintaining full compliance with EFDA requirements.
Pre-Submission Phase
- Device classification assessment
- Gap analysis of existing documentation
- Technical documentation preparation
- Translation of documents (if required)
Submission Phase
- Application submission to EFDA
- Payment of registration fees
- Response to EFDA queries
- Submission of additional information (if required)
Review Phase
- Technical documentation review by EFDA
- Sample testing (if applicable)
- Facility inspection (for certain device classes)
- Follow-up on application status
Post-Approval Phase
- Receipt of registration certificate
- Import permit application
- Post-market surveillance planning
- Renewal planning (every 5 years)
Frequently Asked Questions
Common questions about medical device registration in Ethiopia and how YAM BUSINESS can help.
Our Global Clients
Trusted by pharmaceutical companies across multiple countries for EFDA compliance and Ethiopian market entry.
Our customers
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)
EVA PHARMA
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)