Product labelling is considered a critical element of the evidence submitted for prequalification assessment. Only clear and comprehensive labelling will effectively communicate the product information to the intended user and ensure the safe use of the prequalified male circumcision device.
The version of the instructions for use (IFU) of the product which is submitted with the application form will be reviewed during prequalification assessment. The product labelling will be reviewed as part of the application form, product dossier and inspection of manufacturing site(s).
The IFU is reviewed for clarity, correctness, consistency with the information submitted in the product dossier and in the technical documentation, and with international guidance and requirements, and suitability for the target user group in WHO Member States. The overall feedback relating to labelling review will be provided to the manufacturer after all assessment components have been completed. If requested by WHO, the manufacturer must amend the labelling before the product can be prequalified. The agreed product labelling will be included in the prequalification public report.
The manufacturer must obtain WHO’s written agreement prior to implementing any changes to this version of the IFU otherwise, the application may be cancelled.