Submission Procedure – Full Assessment of an IVD

For a full prequalification assessment, WHO will formally invite the manufacturer to submit:

  • a full product dossier
  • a signed letter of agreement
  • proof of payment of the dossier screening fee.  

Note: Manufacturers should not submit a product dossier to WHO or pay the prequalification fee unless requested to do so by WHO. Dossiers submitted in the absence of a request from WHO will be destroyed without review.

How to organize the product dossier

Manufacturers should make every effort to ensure that their product dossier is clear and well-organized to help make the prequalification assessment procedure as efficient as possible. Poorly-prepared dossiers may be rejected and destroyed without full review. Some general guidance is given below.

The product dossier should include only information in support of the relevant product name, product code(s), regulatory version and manufacturing site(s).

Product dossier completeness

Manufacturers must submit all necessary sections of a product dossier. Failure to do so may result in WHO not accepting the dossier, significant delays in the assessment process, or termination of the assessment process.

Content alignment

Information that was previously submitted in the pre-submission form will be considered during the review of the product dossier. Manufacturers should therefore ensure that the content of the product dossier is consistent with the information submitted in the pre-submission form and that any differences between information included in the pre-submission form and the product dossier are communicated and explained. Inadequacies identified at the pre-submission form stage and communicated by WHO to the manufacturer are expected to be addressed during product dossier development and submission.

Layout and order

The following format for the dossier should be applied:

  • Use the numbering format of 1 of 2, 2 of 2, etc.
  • Clearly divide the submission into sections, with each section page clearly numbered so that it can be identified easily.
  • Include a table of contents.
  • Use the Product dossier checklist (document PQDx_049) as the first page, and cross-reference all sections of the dossier to this first page.
  • Ensure that the physical pages of the dossier and the page numbers correspond.
  • Ensure that appropriately named tab identifiers are used. The names should link directly with the sections of the dossier. For example, the labelling information should be separated from the other documents by a tab identifier named “Section 8.1 Labels”.
  • Use standard A4 paper used for the printed version of the dossier.
  • Ensure that text and tables are prepared using margins that allow the document to be printed on A4 size paper. The left-hand margin should be sufficiently large that information is not obscured through binding.
  • Use font sizes for text and tables that are of a style and size that are large enough to be easily legible, even after photocopying or when provided electronically. Fonts smaller than 12 points should be avoided whenever possible, except in tables and footnotes where a font size of 10 points is acceptable.

Product dossiers should be compiled according to the above requirements described above. However, WHO may accept submissions previously prepared for national regulatory authorities if:

  • all the information required by WHO is provided
  • the information is fully cross-referenced with the Product dossier checklist.

Manufacturers should contact WHO to determine if a particular prior regulatory authority submission is appropriate to substitute for the dossier.

Language and units of measurement

All documents included in the dossier must be in English (unless other arrangements have been made with WHO before submission of the dossier).

Any translations of documents must be have been carried out by a certified translator; an official document attesting to the accuracy of the translation and providing details about the credentials of the translator must be included. Both the original and the translated document(s) should be included in the dossier.

All measurement units used must be expressed in the International System of Units (SI).

Dossier format

One printed copy and one electronic copy (exact duplicate of the printed copy in a CD or DVD only) of the entire product dossier must be submitted. A signed document attesting that the content of the electronic version is an exact duplicate of the printed copy must also be provided. The printed product dossier should either be bound or presented in a clearly marked set of ring-binders.

The printed copy will be destroyed by WHO after completion of the dossier screening phase.

Electronic copy requirements

PDF is the primary file format 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: it can consist of up to 125 characters and include spaces, dashes (but not elongated dashes), underscores and full stops. However, the name of the file must not contain any of the following special characters or it will fail to load.

  • apostrophe (’)
  • asterisk (*)
  • backward slash (\)
  • colon (:)
  • double quotation marks ("")
  • elongated dash (–)
  • forward slash (/)
  • greater than sign (>)
  • less than sign (<)
  • pound sign (£)
  • question mark (?)
  • single quotation mark (')
  • vertical bar (|)
  • tilde (~)
  • various other symbols (e.g., →,*,β,α,∞,±,™)

When creating a PDF from the source document (e.g. Microsoft Word document), please consider whether or not to use Adobe® plug-ins to create PDF files and/or capture or display data; information may not display correctly if a reviewer does 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 in legibility to those produced directly from the source document, such as a Microsoft Word document. For any scanned document, we highly recommend that you perform optical character recognition (OCR) so that the text is searchable. Check that the content has been correctly converted by: (1) highlighting an area of text and (2) 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. WHO recognizes that use of OCR may not be feasible in some cases for documents that include figures and/or images. So it may sometimes be appropriate to include scanned documents in the electronic copy.

Dossier submission

The dossier should be sent to:

WHO Prequalification Unit: in vitro diagnostics
World Health Organization

20, Avenue Appia
1211 Geneva 27