The registration process for a medical device in Kenya, as per KeMDA regulations, typically involves the following steps:
1. Pre-submission Meeting: A pre-submission meeting with KeMDA is recommended to discuss the registration requirements and process.
2. Application Submission: Submit a completed application form along with required documents, including technical specifications, labeling, and evidence of regulatory approval in the country of origin (if applicable).
3. Technical Review: KeMDA conducts a technical review of the application to assess the safety, quality, and efficacy of the medical device.
4. Inspection: KeMDA may conduct an inspection of the manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).
5. Laboratory Testing: Samples of the medical device may be required for laboratory testing to verify compliance with relevant standards.
6. Registration Certificate: If the application is successful, KeMDA issues a registration certificate allowing the medical device to be marketed and distributed in Kenya.
7. Post-Market Surveillance: KeMDA may conduct post-market surveillance to monitor the safety and performance of the registered medical device.
It's important to note that the specific requirements and process may vary depending on the classification of the medical device and any specific regulations issued by KeMDA.
