In Kenya, a local representative plays an important role in the registration process of medical devices and diagnostics, particularly for manufacturers based outside of Kenya. The role of a local representative typically includes:
1. Acting as a Point of Contact: The local representative serves as the primary point of contact between the manufacturer and the regulatory authority, KeMDA. They are responsible for facilitating communication and ensuring that all required documentation is submitted correctly and in a timely manner.
2. Assisting with Regulatory Compliance: The local representative helps ensure that the medical device or diagnostic meets all regulatory requirements in Kenya. This includes assisting with the preparation and submission of registration documents, as well as coordinating any necessary inspections or testing.
3. Post-Market Responsibilities: The local representative may be responsible for post-market surveillance activities, including reporting adverse events or recalls to KeMDA on behalf of the manufacturer.
4. Maintaining Records: The local representative is often required to maintain records related to the registration and distribution of the medical device in Kenya, including the registration certificate and any post-market surveillance data.
The local representative plays a crucial role in ensuring that medical devices and diagnostics comply with regulatory requirements in Kenya and can be safely marketed and distributed in the country.
