Convergence in Post-Market Surveillance

Post-market surveillance monitors the quality of IVD medical devices that are sold in a country. Following reports of adverse events or product failures corrective action may be taken by the manufacturers, or in extreme cases products can be removed from the market.

Surveillance may be 'reactive', where National Regulatory Authorities are informed of adverse events or 'active', where devices are quality checked (batch tested) by accredited laboratories.

PAHWP will work with the African Society of Laboratory Medicine and other partners to encourage reactive and active post-market surveillance for IVD medical devices and towards a network of accredited laboratories and a communication platform for sharing information.

©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics