The manufacturer of a prequalified male circumcision device (MCD) must report to WHO:

• changes to the prequalified product or its design, labelling or manufacture
• changes to the quality management system (QMS) under which the product was designed and manufactured
• other reportable administrative changes.

To determine whether a change to the product, including its design, labelling and manufacture, or to the QMS, requires reporting to WHO, the manufacturer should evaluate the potential effect this change may have on the safety, quality or performance of the product.

For all reportable changes to a prequalified product, the manufacturer must submit a completed change report form and supporting documentation and, in some cases, a new prequalification application. The manufacturer must communicate to WHO its intent to introduce a reportable change well in advance (i.e. early in the process of designing and validating the change), in order to allow sufficient time for WHO to assess the change before its implementation. WHO will not approve any changes without due assessment. Depending on the type of change, the assessment may also include an inspection of the manufacturing site(s) and/or the review of clinical evidence.

Once the change report form and supporting documentation have been received by WHO, they will be screened for completeness and, provided all the required information has been supplied, they will undergo assessment by WHO. If any aspect of the change report form or the supporting documentation is incomplete, the manufacturer will be informed in writing and requested to complete it by a specified deadline set by WHO. If the manufacturer fails to meet the deadline, the product may be removed from the WHO List of Prequalified MCDs.

WHO will inform the manufacturer in writing of the outcome of its assessment of the change. The manufacturer will also be notified if WHO deems (based on the nature of the change and its potential impact on the quality, safety and/or performance of the product), that an inspection of the manufacturing site(s) and/or the review of clinical evidence is also required.

Once WHO is satisfied that the prequalification change assessment of a product is complete, and provided that the overall findings demonstrate, as determined by WHO, that the product continues to meet all WHO prequalification requirements, then the WHO List of Prequalified MCDs will be updated, as necessary, to reflect the relevant change accepted by WHO. If the submitted documentation supporting the change does not meet WHO prequalification requirements or if all the requested information is not provided by the manufacturer within the specified deadline, WHO will reject the change. The impact of such a decision on the prequalification status of the prequalified MCD will be communicated to the manufacturer in writing by WHO.

If a new prequalification application is needed

In some cases, changes affect the safety and performance of the product to such a magnitude that a new application for WHO prequalification assessment is required. This will occur where it is deemed that the changes have resulted in a product or application information of substantial difference to that which was prequalified. In these cases, WHO will notify the manufacturer that a new application to WHO prequalification must be submitted.