Contents of a Dossier

WHO reviews the product dossier of a male circumcision device (MCD) to:

  • assess the product and how it performs
  • assessing the product manufacture
  • determine whether the manufacturer's QMS is of an adequate standard to warrant a WHO prequalification site inspection.

It must therefore contain:

  • product information
  • design and manufacturing information
  • product verification and validation information
  • labelling information
  • commercial history
  • regulatory history
  • information about the quality management system.

Details of the information provided for each of the above categories is given in the drop-down sections below.