Pan African Harmonisation Working Party
- African Forum
Regulation of medical products is undertaken by National Regulatory Agencies (NRA) who are mandated by law to protect public safety.
In most but not all countries there is legal framework for the control of medical commodities such as medicines, vaccines and medical devices which includes medical diagnostics.
The mandate of National Regulatory Authorities is to protect the health of the population but they also have a duty to ensure the population has access to beneficial new medical products without undue delay.
Before approving the registration of a new in vitro diagnostic device the NRA will review a dossier of evidence submitted by the manufacturer or their agent/distributor. NRA may also review data obtained during post-market surveillance.