About Ethiobiomedical
“Ethiobiomedical” is a regulatory consultancy services providing company based in Ethiopia and is established to support medical device manufacturers to comply with Ethiopian regulatory requirements and market their products in the country. As it currently has partners from some selected Countries/Regions including- Kenya, Ghana, Nigeria, India, China, USA, EU, Australia, S. Korea, and Türkiye, Ethiobiomedical can also handle the registration process of its clients' devices effectively through its partners in these countries. To achieve its goals of ensuring timely and efficient regulatory compliance with Ethiopian Food and Drug Authority for the manufacturers, it works with its domestic partner companies who are legally licensed to locally represent foreign manufacturers. Ethiobiomedical has a team of multidisciplinary competent experts with more than 10 years of demonstrated experience in medical devices regulation who are committed to support manufacturers of medical devices and IVDs to register their devices with Ethiopian Food and Drug Authority (EFDA).
Our Expertise:
We are a team of experienced regulatory consultants specializing in guiding medical device manufacturers through the complex landscape of global regulatory submissions (mainly focusing on Ethiopia and some selected African countries). With a deep understanding of international standards and a proven track record of success, we help our clients navigate the challenges of bringing safe and effective medical devices to market (by collaboratively working with our partner companies who are licensed to do the registration processes on behalf of the products owners /manufacturers).
Our Services:
Support in Regulatory Strategy Development:
Ethiobiomedical supports the manufacturers in the following areas:
- Risk assessment and classification
- Selection of appropriate regulatory pathways
- Development of a comprehensive registration plan
Advice in the following technical documentation preparation process:
- Design and development files
- Non-clinical and clinical study data
- Risk management plans
- Quality management system documentation
Advice on the Submission Preparation and Filing:
- Compilation and formatting of regulatory submissions
- Submission preparation and filing with regulatory authorities
- Interaction with the Ethiopian FDA on behalf of the product owner (and assigning local representative to handle the process of registration in other selected African countries).
Support in the Post-Market Surveillance activities
- Assist manufacturers in post-market safety and performance data collection and analysis
- Adverse event reporting and management
- Regulatory updates and compliance monitoring
Other related works by Ethiobiomedical
* We publish creative blogs on how manufacturers and suppliers of medical devices including IVDs demonstrate their products compliance with EFDA’s regulatory requirements.
*We publish any important and critical changes or updates from the EFDA that may affect medical device manufacturers who have registered or are planning to register their products with the Authority.
*We also help manufacturers in reviewing their documents produced with the aim of complying with the EFDA's regulatory requirements of Medical devices Good Manufacturing Practice which is in alignment with the ISO 13485- Medical device Quality Management System.
Why Choose Us:
Expertise and Experience: Our team possesses in-depth knowledge of regulatory requirements and a wealth of experience in successful registrations of medical devices including in vitro diagnostic medical devices in Ethiopia.
Time and Cost Efficiency: As much as possible, by in advance review of the manufacturer's technical documentations and positive interactions with the Ethiopian FDA, we streamline the registration process and minimizing delays.
Increased Success Rates: Our strategic approach and careful attention to detail enhance the likelihood of regulatory approval and accelerate market entry.
Client-Centric Approach: We prioritize open communication, personalized service, and building long-term partnerships with our clients.
Our Commitment:
We are dedicated to providing exceptional service, ensuring regulatory compliance, and supporting the successful commercialization of your medical devices in the country.
Please do not hesitate to contact us for any help regarding the detail understanding of medical device regulation system, its registration processes and to learn more about our services and how we can assist you. You can also send your queries on the email address- admin@ethiobiomedical.com.