Medical Device Authority (MDA)
Introduction to Medical Device Regulation and Healthcare institution
- Background- cabinet decision
- Regulatory Framework
- Elements of Regulatory Program
- Harmonization
- Definition Medical Device
- Pre-market, Placement on Market and Post Market
- Institutional structure of Medical Device Regulatory System
- Overview of the Regulatory system (Acts 737 & 738)
- Risk Based Classification
- MD life cycle
- Regulated Activities of Medical Device in Healthcare Facilities
- Procurements
- Usage, maintenance & Disposal Medical Device in Healthcare Institution