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Guiding You Through Medical Device Compliance

We specialize in helping medical device manufacturers navigate the complex regulatory landscape in Ethiopia. Our expert team ensures that your products comply with the latest EFDA requirements, facilitating smooth market entry.

With in-depth knowledge of medical device regulations, we provide tailored solutions to ensure compliance, from initial registration to post-market surveillance.

  • Proven Track Record of Compliance
  • End-to-End Regulatory Support
  • Trusted by Leading Medical Brands

what we do

Services

Our Core Services

Medical Device Registration

We provide end-to-end medical device registration services to ensure your product complies with Ethiopian regulatory requirements. From initial product assessment to final approval, we guide you through every step of the registration process, ensuring a smooth and timely market entry.

Regulatory Compliance Consultancy

Navigating the regulatory environment can be complex, especially in emerging markets like Ethiopia. Our team offers expert consultancy on regulatory strategies, helping you comply with local laws and international standards, and ensuring that your products meet all necessary certifications and approvals.

Pre-Registration Dossier Evaluation

Before submitting your medical device registration application, it’s crucial to ensure your pre- registration dossier is complete and meets all regulatory requirements. Our pre-registration dossier evaluation service reviews your submission to identify potential gaps and ensure a successful registration process.

Post-Marketing Surveillance and Post-Market Adverse Event Reporting

After a device reaches the market, regulatory oversight continues. We assist with post- marketing surveillance to monitor the safety and performance of your medical device, including gathering data on potential adverse events. Our services help you maintain compliance with ongoing regulatory reporting requirements, ensuring that any issues are promptly addressed.

Post-Approval Change Notification / Variations

We provide expert assistance with post-approval changes and variations, helping you navigate the necessary regulatory processes when modifications or updates to your medical device are required. Whether it's changes to the device design, labeling, or manufacturing process, we ensure that all regulatory notifications are accurately submitted to maintain compliance.

Local Representation

Our local representation service helps clients stay up to date with the latest regulatory changes and requirements in Ethiopia. By acting as your local liaison, we ensure your products remain in compliance with evolving regulations and provide immediate support to address any local client needs, helping you maintain an efficient and effective market presence.

Any questions regarding our services?

What services do you offer for medical device registration?
We provide comprehensive medical device registration services, including dossier preparation, regulatory submission, and compliance support to ensure your product meets Ethiopian regulations.
How long does the medical device registration process take?
The registration timeline varies based on the device classification and regulatory requirements. We help streamline the process to ensure a faster and more efficient approval.
Do you assist with post-market surveillance and compliance?
Yes, we provide post-marketing surveillance services, including adverse event reporting and compliance monitoring, to ensure ongoing regulatory adherence.
Can you help with variations or post-approval changes?
Absolutely. We handle post-approval modifications, such as changes in product design, labeling, or manufacturing processes, ensuring compliance with EFDA regulations.
Do you provide regulatory consulting for international medical device manufacturers?
Yes, we assist international manufacturers in understanding Ethiopian regulatory requirements, appointing local representatives, and ensuring a smooth market entry.