Registration, Licensing & Enforcement Division
Article Index
Page 1 of 6
FUNCTIONS OF REGISTRATION, LICENSING AND ENFORCEMENT DIVISION
- Develop, plan, coordinate and implement activities of assessment, review and approval of application for;
i - registration of medical devices
ii - registration of Conformity Assessment Body (CAB)
iii - licensing of establishment
- Coordinate and implement technical advisory activities on registration of medical devices, registration of Conformity Assessment Body (CAB) and licensing of establishment;
- Develop, plan, coordinate and implement surveillance and vigilance activities pertaining to safety and performance of the medical devices and establishments’ obligations in the post-market phase through:-
i - complaints on safety and performance of medical devices
ii - mandatory problem reportingiii - field corrective actions
iv - recall
- Develop, plan, coordinate and implement enforcement activities including;-