There are several challenges faced during the registration of medical devices and diagnostics in Kenya. Some of the key challenges include:
1. Regulatory Requirements: Keeping up with the evolving regulatory requirements and ensuring compliance can be challenging, especially for manufacturers based outside of Kenya.
2. Resource Constraints: KeMDA may face resource constraints, including limited staff and expertise, which can lead to delays in the review and approval process.
3. Documentation Requirements: The documentation required for registration can be extensive and complex, requiring manufacturers to gather and submit a large amount of information.
4. Testing and Certification: Meeting the testing and certification requirements, including obtaining ISO certification and conducting local testing, can be challenging and time-consuming.
5. Local Representation: Having a local representative is a requirement for registration in Kenya, and finding a qualified and reliable representative can be a challenge for manufacturers.
6. Cost: The cost of registration, including fees for application, testing, and certification, can be significant, especially for smaller manufacturers.
7. Market Access: Once registered, accessing the market and navigating distribution channels in Kenya can also be challenging for manufacturers.
Navigating the registration process for medical devices and diagnostics in Kenya requires careful planning, resources, and expertise to overcome these challenges and successfully bring products to market.
