Pre-market division & Post-market and enforcement division

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

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