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Pre-market division & Post-market 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;
  • Assuring safety throughout the lifespan of a medical device at the post-market stage
    • complaints on safety and performance of medical devices
    • mandatory problem reporting
    • field safety corrective action
    • medical device recall
  • Develop, plan, coordinate and implement enforcement activities including; -

i - Inspection,

ii - Intelligence and investigation,

iii - Search and seizure

iv - Prosecution

iii - Search and seizure

iv - Prosecution