A manufacturer who wishes to apply for evaluation for prequalification of an in vitro diagnostic (IVD) must first complete and submit a pre-submission form, to provide summary information about the product, its regulatory version and the manufacturer. This information will enable WHO to determine whether the product is eligible for prequalification assessment and, if so, the type of assessment (full or abridged) that will be applied. It is also used to determine the regulatory version intended for prequalification and to plan for each of the components of the prequalification assessment process.
Applications for WHO prequalification of IVDs are only accepted for products that are commercially available at the time of submission for prequalification assessment. Any exemptions must be agreed upon by WHO prior to the submission of the application for prequalification.
Each pre-submission form can refer to only one IVD and manufacturers may make no more than two attempts to submit a pre-submission form for a specific product. If, after two attempts to submit a pre-submission form a manufacturer has not provided the necessary information, the application for prequalification for that product will be rejected.
Manufacturers must not submit a product dossier together with the pre-submission form. Dossiers that are submitted in the absence of a formal request from WHO will be destroyed without prior notice.
Documentation to be submitted
The manufacturer must submit the following documentation
- a completed pre-submission form
- a signed letter stating that the two people referred to are authorized to represent the manufacturer for the purposes of prequalification of the product
- photographs of all kit components (packaged and individually)
- instructions for use
- (if relevant) completed Annex 1: Eligibility for abridged prequalification assessment.
Where to submit the documentation
The pre-submission form and the respective attachments must be submitted electronically — as searchable PDF files — to: email@example.com.
The completed pre-submission form and supporting documentation will be reviewed against the eligibility criteria for IVD prequalification to determine eligibility for prequalification assessment. If the product meets the criteria the manufacturer will be informed about the next steps to be followed, depending on the type of assessment (full or abridged) to be applied to the product. If necessary, WHO may request additional information and/or clarifications to assist it in the eligibility decision. The manufacturer must provide WHO with the information and/or clarifications so requested within the deadlines prescribed by WHO.
WHO will inform the manufacturer in writing of its decision as to whether or not the product is eligible for prequalification assessment. If a product is eligible for prequalification assessment, WHO will request the manufacturer to complete, sign and return to WHO a letter of agreement confirming that the product will undergo assessment by WHO, and the manufacturer's commitment to comply with the provisions of the prequalification assessment process. A prequalification dossier screening and assessment fee will also be due for payment by the manufacturer. Assessment cannot be initiated until the manufacturer has provided a signed and completed letter of agreement, and proof of payment the applicable prequalification fee.