Submission Procedure for a Reportable Change
For all reportable changes to a prequalified in vitro diagnostic, the manufacturer must submit a completed Change Report Form to WHO, together with supporting documentation. In some cases, changes will affect the safety and performance of the product to such an extent that a new application for WHO prequalification assessment is required. This will occur if it is deemed that the changes have resulted in a product or application information of substantial difference to that which was prequalified. WHO will accordingly notify the manufacturer that a new application to WHO prequalification is required. For administrative changes, the following additional information should also be provided:
- a declaration that the change only affects the product name, product code(s)
- manufacturer name and has no impact on the quality, safety and/or performance, as supported in the submitted prequalification documentation and the reason(s) for making the changes
- the new product labelling (labels, instructions for use, and any other printed or electronic labelling material) reflecting the changes.
The manufacturer should inform WHO of the intention to report a change by email to diagnostics@who.int and subsequently complete and submit a Change Report Form on a CD or DVD.
The change report must be submitted on a CD or DVD. Submissions by email will be rejected. Hardcopies are not required.
The layout and order must be easy to follow and appropriately identified. The attachments must be clearly identified and divided into sections, as listed in Section 4 of the PQDx Change
Report Form:
- The cover of the CD or DVD should indicate "Change Report Form" and include detailed information such as the name of the product, PQDx number, name of the manufacturer and date of submission.
- PDF is the primary file format to be used for the electronic copy. However, you must not include any PDF that requires a password to open it.
- The electronic copy must be organized as per the format prescribed for the printed copy. The name of the file name should be descriptive of its content and meaningful to the reviewers. The name can be up to 125 characters and can have spaces, dashes (not elongated dashes), underscores, and full stops. However, the name of the file must not contain any of the following special characters, otherwise will not be possible to upload it:
- apostrophe (´)
- asterisk (*)
- backslash (\)
- colon (:)
- double quotation mark (")
- forward slash (/)
- greater than sign (>)
- less than sign (<)
- pound sign (£)
- question mark (?)
- single quotation mark (')
- tilde (~)
- vertical bar (|).
When creating a PDF from the source document (e.g. Microsoft Word document), please remember that when using Adobe®plug-ins to create PDF files, and/or capture or display data, information may not display correctly for those reviewers who do not have access to certain plug-ins:
- All PDF files should be created directly from the source documents whenever feasible rather than creating them by scanning. PDF documents produced by scanning paper documents are far inferior to those produced directly from the source document, such as a Microsoft Word document, and should be avoided if at all possible. Scanned documents, particularly tables and graphs, can be difficult to read.
- For any scanned document, we highly recommend that you perform optical character recognition (OCR) so that the text is searchable. Check to see that the content has been correctly converted by: (i) highlighting an area of text and (ii) searching for a word or phrase.If the word or phrase is not returned in the search, then the OCR did not recognize the text.
- Submit all documents presented in the change report in English (unless other arrangements have been made with WHO before submission of the documentation).
- Any translation of documents must be carried out by a certified translator. Provide an official document attesting to the accuracy of the translation and details on the credentials of the translator. Provide both the original and the translated documents.
- All measurement units used must be expressed in the International System of Units (SI).
The manufacturer's communication of its intent to introduce a reportable change well in advance (i.e. early in the process of designing and validating the change), 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 performance evaluation.
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 within a specified timeline set by WHO. If the manufacturer fails to complete the aspect within the specified timeline, the product may be removed from the WHO List of Prequalified IVDs.