Medical products are regulated to protect the health of the population and to ensure timely access to new beneficial and safe medical products. Regulation of medicines is widely practiced but control of medical devices and diagnostic tests has been neglected in some parts of Africa.

Guiding principles  for regulating medical devices were issued in 1991 by WHO/PAHO in collaboration with the US FDA.

Regulation should be based on scientific evidence and should be proportionate to the hazard presented by the device

  • Pre-market control is applied during the product registration process where the manufacturer provides a dossier of evidence to demonstrate that the product and the manufacturing process are of a satisfactory standard.

  • Market controls ensure that the product is supplied to the correct population and that misleading claims are not made.

  • Post market surveillance has an important role in ensuring quality. It may be 'passive' where problems are reported by the manufacturer or the user, or 'proactive' where products are checked (batch testing).

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