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Notice is given on the Renewal of Reregistration of Medical Devices Including In-Vitro Diagnostics

The Pharmacy and Poisons Board (“the Board”), is empowered under Section 3A(c) of the Pharmacy and Poisons Act, Chapter 244 Laws of Kenya, to grant or withdraw marketing authorization for Medical Devices including In-Vitro Diagnostics subject to appropriate conditions. In line with this mandate, in order to ensure continued quality, safety and performance of registered medical Devices including In-Vitro Diagnostics, the Board grants certificates of registration with a limited validity period of five (5) years from the date of issue, subject to the requirement of annual retention in the register and renewal of registration.

In light of the above, all Marketing Authorization Holders (MAHs) are hereby notified of the obligation to initiate the renewal process for products that are approaching or have exceeded their validity period in accordance with Rule 9 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022. Therefore, MAHs are guided as follows:

1. a)For MDs/IVDs granted marketing authorization (MA) in 2020, submit renewal applications at least two (2) months prior to expiration of the MA;
2. b)For MDs/IVDs initially authorized in 2018 and 2019, ensure re-registration is completed no later than 1^st January 2026.

For more details on implementation of the re-registration requirements, kindly access the Guidelines on Registration of Medical devices including In-Vitro Diagnostics (HPT/PER/GUD/011) on our website web.pharmacyboardkenya.org. Additionally, you may contact the Board through phone number, +254 709 770 100, for any inquiries or clarifications.

Your cooperation is appreciated.

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