The timelines for the review and approval of medical devices in Kenya can vary depending on factors such as the complexity of the device, the completeness of the submission, and the workload of the regulatory authority, KeMDA. However, in general, the review and approval process can take several months to over a year.
Here is a rough estimate of the timelines involved:
1. Initial Review: The initial review of the application and documents submitted typically takes a few weeks to a few months, depending on the workload of the regulatory authority.
2. Technical Review: The technical review of the device, including assessment of safety, quality, and efficacy, can take several months. This may involve review by a panel of experts and may also include requests for additional information or clarification.
3. Inspection: If an inspection of the manufacturing facilities is required, this can add several weeks to the timeline, depending on the availability of inspectors and the complexity of the inspection.
4. Decision: Once the review process is complete, KeMDA will make a decision on the application. This decision can take several weeks to a few months, depending on the complexity of the application and the workload of the regulatory authority.
The entire process from submission to approval can take anywhere from several months to over a year. It is important for manufacturers to plan accordingly and ensure that all requirements are met to avoid delays in the approval process.
For more detailed information, you may want to visit the official website of the Kenya Medical Devices Authority or speak with Artixio Expert .
