StreetAddis Ababa 12345

+251-989008621

About us

  • East Africa Medical Device Ltd. is a MedTech consulting firm dedicated to assisting medical device manufacturers globally in navigating the complexities of placing compliant medical devices in the African market. To meet our clients' needs, we consistently provide current information on medical device regulations.

    Our mission is to support manufacturers in achieving their design, development, manufacturing, maintenance, distribution, and market monitoring objectives across diverse regions. To facilitate this, we have established a network of partners to ensure compliance and aid in discussions with regulatory authorities.

    Focus on the growth of your business while we manage your Quality and Regulatory Affairs activities. We are passionate about helping companies obtain market authorization for their products and are committed to simplifying the complex certification processes involved with UDA, TMDA, PPB, EFDA, and others. We achieve this by breaking down regulations into plain language and offering user-friendly tools that empower you to manage your Quality Management System (QMS) independently.

    By encouraging you to take control of your projects, we help you reduce reliance on external testing and certification bodies, resulting in significant time and cost savings, as well as a dramatic increase in your National Regulatory Authority (NRA) certification success rate. Our website and services are designed to empower you in achieving ISO 13485 compliance and keeping you informed about the latest developments that impact your products' compliance.

Fair Prices

Authorized Representation

Professional Staff

Reliable

 

Our Services

Consultation and Implementation: Support companies in designing, implementing, and maintaining a robust Quality Management System (QMS) aligned with ISO 13485 or other relevant standards.

Training and Audits: Offer training sessions for staff on QMS principles and perform internal audits to ensure compliance.

Risk-Based Approach: Assist organizations in integrating risk management practices into their QMS.

  • **Market Entry Strategy:** We offer comprehensive guidance for multinational companies looking to navigate the complex regulatory landscape of East African countries, such as Ethiopia, Kenya, Tanzania, and Uganda. Our expertise helps businesses understand and comply with the specific requirements and nuances of each market, ensuring a smooth and efficient entry process.

    **Product Registration:** Our dedicated team facilitates the product registration process by working closely with local health authorities. We streamline this crucial step, helping multinational companies to efficiently obtain the necessary approvals and ensure that their products are compliant with local regulations.

    **Labeling and Documentation:** We prioritize compliance by ensuring that all labeling requirements are meticulously met. Our services include the preparation and review of necessary documentation for submissions, helping businesses to adhere to local laws while presenting their products in the best possible light.

Startups Support:

  • **Market Entry Strategy:** We specialize in advising startups on effectively navigating the dynamic East African market. Our expertise helps new businesses identify unique opportunities, understand local consumer behavior, and develop strategies that align with regional trends and cultural considerations, ensuring a successful market entry.

    **Regulatory Pathways:** Our team assists startups in comprehending the complex regulatory pathways and requirements essential for operating in East Africa. We provide in-depth analysis and support for understanding local laws, compliance procedures, and industry-specific regulations, facilitating a smoother entry into the market while ensuring adherence to all necessary legal frameworks.

    **Clinical Trials:** We offer comprehensive guidance on conducting clinical trials in the East African region. Our services include navigating the regulatory landscape, understanding ethical considerations, and identifying suitable partners and sites for trials. With our support, startups can effectively plan and execute their clinical research initiatives, ensuring robust and reliable results while adhering to local standards.

What clients say

59

Projects done

18

Happy Clients

4

Years of Experience

9

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