Pre-market division & Post-market and enforcement division
Article Index
Page 1 of 6
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