Prequalification Procedures and Fees: In Vitro Diagnostics
This Prequalification Procedures and Fees section is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification of an in vitro diagnostic (IVD).
Who can participate in WHO prequalification of IVDs?
Any legal manufacturer of an IVD can express an interest in having its IVD evaluated by WHO, provided that product is eligible for evaluation.
Applications for WHO prequalification of IVDs are accepted only 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.
What are the steps of IVD prequalification?
The following is an overview of the prequalification process for an IVD:
- The manufacturer completes the pre-submission form and provides all supportive documentation by submitting it by email at email@example.com.
- Note: The maximum size of attached files accepted by WHO's firewall is 10MB. If the manufacturer does not receive a response in 7 days, the email may have been rejected by the firewall without receiving a failure notification.
- The WHO schedules with the manufacturer a pre-submission meeting. A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification, but is also available to manufacturers who have already submitted products for prequalification.
- WHO screens the pre-submission form to determine whether the product is eligible for prequalification and, if so, what type of assessment (full or abridged) should be applied.
- In the case of full assessment, the manufacturer will be invited to submit a product dossier. WHO screens the product dossier for completeness. If the dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period. WHO then reviews the product dossier to: assess evidence in support of safety and performance of the product; determine whether the manufacturer’s quality management system (QSM) is of an adequate standard to warrant an inspection of the manufacturing site; and assess product design and manufacture. If the dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier is considered complete, prequalification evaluation will proceed to laboratory evaluation and manufacturing site inspection.
- In the case of abridged assessment, the manufacturer will be invited to submit an abridged product dossier that summarizes key aspects of its QMS, the product, its design, its performance, and product manufacture. If the abridged product dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period.
- Performance evaluation is undertaken to assess the performance and operational characteristics of the product under assessment and is carried out by a laboratory listed by WHO, according to publicly available standard evaluation protocols, which consist of an analytical part and a clinical part.
- The manufacturing site inspection is carried out to assess compliance with the quality management standard ISO 13485: 2016, focusing on the suitability of the implemented processes and procedures for the reliable supply of products to WHO Member States.
- If a product meets prequalification requirements it is added to the WHO List of Prequalified In Vitro Diagnostics and becomes eligible for UN procurement.
Full assessment or abridged assessment
There are two types of prequalification assessment for IVDs: full assessment or abridged assessment.
|Prequalification stage||Full assessment||Abridged assessment|
|Review of a product dossier||Yes||Yes|
|Inspection of a manufacturing site||Inspection of manufacturing site(s) under full prequalification assessment||Manufacturing site inspection of abridged scope|
|Performance evaluation including operational characteristics||Yes||Yes|
WHO will apply the abridged prequalification assessment process if:
- if a stringently assessed regulatory version is submitted for prequalification
- if a non-stringently assessed (rest of world) regulatory version of the product is submitted for prequalification assessment but a stringently assessed regulatory version also exists, and there are no substantial differences between the two regulatory versions.
WHO performs prequalification assessment according to agreed target timelines. These will differ depending on the type of assessment (full or abridged) and the type of performance evaluation pathway that has been chosen.
Cancellation of an application by WHO
WHO may cancel the application for a specific product if:
- the product dossier or, in the case of an abridged assessment the technical documentation, does not contain all of the required information or does not meet WHO prequalification requirements and/or
- the manufacturer is not able to, or fails to, provide the required or requested information within a specified deadline and/or
- the product does not meet the acceptance criteria for the performance evaluation and/or
- the manufacturer is not able to, or fails to, implement any corrective actions that WHO may require within a specified deadline and/or
- the information supplied is inadequate to complete the prequalification assessment in a timely manner.
Withdrawal of an application by the manufacturer
The manufacturer may withdraw its application for prequalification assessment at any time or stage. To exercise this right of withdrawal, the manufacturer must provide WHO with written notice specifying the product(s) to be withdrawn.
If WHO cancels an application, or if the manufacturer withdraws its application, the manufacturer will not be allowed to re-apply for WHO prequalification assessment for a period of time determined by WHO, usually one year from the date of notification of cancellation, unless otherwise agreed by WHO.
Reporting and communication of assessment outcomes
The cancellation or withdrawal, at any time and for any reason, of an application for prequalification assessment of a specific product will not prejudice or otherwise affect WHO's rights to use, publish, issue, share with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (in accordance with varoious provisions, including provisions regarding the protection of any commercially-sensitive information of the manufacturer) any outcomes, reports, notices and/or results — whether in draft or final form, and whether positive or negative — arising from or relating to the prequalification assessment process, including without limitation any WHO Notices of Concern, WHO Notices of Suspension, WHO information notices for users and/or manufacturer-issued field safety notices.
What happens when an IVD is prequalified?
Once WHO is satisfied that the prequalification assessment process is complete for the relevant product and that the product meets the WHO prequalification requirements, the product bearing a specific product name, product code(s) and regulatory version, as manufactured at the specific manufacturing site(s) inspected, will be included in the WHO List of Prequalified IVDs, posted on this website. The List will also specify the the manufacturer’s name, the product packaging and the year in which the product was prequalified.
The manufacturer will receive a letter of prequalification from WHO informing it of the outcome of the overall prequalification assessment of the product. Following the product's inclusion in the List, the manufacturer will be responsible for:
- fulfilling prequalification commitments
- annual reporting
- reporting of changes
- meeting post-market surveillance obligations
- preparing and opening the manufacturing site(s) for re-inspection
- continued compliance with WHO prequalification technical specifications.
The decision to include the product in the WHO list of prequalified IVDs is made based upon information available to WHO at the time of the prequalification assessment, including information obtained as a result of the product dossier review, performance evaluation, the inspection of manufacturing site(s) and/or the labelling review conducted by WHO. This decision is subject to change on the basis of new information that may become available to WHO.
In addition, for any IVD that underwent full (as opposed to abridged) assessment, a WHO Public Inspection Report (WHOPIR), for any inspection that was conducted and concluded successfully, is posted on this website.
The decision to include the product in the WHO List of Prequalified IVDs is made based upon information available to WHO at the time of the prequalification assessment, including information obtained as a result of the product dossier review, performance evaluation, the inspection of manufacturing site(s) and/or the labelling review conducted by WHO. This decision is subject to change on the basis of new information that may become available to WHO.
Information sharing with national regulatory authorities
As part of the prequalification assessment process WHO may share the manufacturer’s application and related information with interested national regulatory authorities (NRAs) – subject to WHO entering into an appropriate confidentiality undertaking with each such NRA. Furthermore, the outcome of any joint review of information by WHO and NRA(s) may be used by WHO, at its discretion, as part of the prequalification assessment process.
Duration of validity of prequalification status
The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, which include:
- meeting prequalification commitments
- annual reporting
- reporting of changes
- fulfilling post-market surveillance obligations
- undergoing manufacturing site re-inspection
- ensuring ongoing compliance with WHO prequalification technical specifications.
WHO will reassess products included in the WHO List of Prequalified IVDs and their associated manufacturing sites at intervals determined by WHO using a risk-based approach. If, as a result of this reassessment, it is found that a product and/or specified manufacturing site(s) no longer meets WHO requirements, such products will be removed from the list. Failure of a manufacturer to participate in the reassessment procedure will also lead to delisting of the product from the WHO List of Prequalified IVDs. Failure to meet prequalification commitments within the agreed deadlines will lead to delisting of the product(s) from the WHO List of Prequalified IVDs.
Prequalification fees are levied to cover part of the costs associated with product dossier screening and review, performance evaluation commissioned by WHO, manufacturing site(s) inspection, review of labelling, dissemination of prequalification information, change assessment and dissemination of change information.
Fees must paid within a defined timeline. Failure to do so will result in cancellation of the assessment application, or change request application, or suspension of prequalification status of the prequalified product, whichever is applicable. Fees are non-refundable.
Payment of prequalification fees does not guarantee that the product will be prequalified and/or that, if prequalified, the product will retain its prequalification status for any minimum duration.
A prequalification assessment fee is charged to a manufacturer once its application has been determined to be eligible for WHO prequalification assessment. For a product undergoing full assessment, US$ 5000 is charged for dossier screening and US$ 12,000 for product assessment. For a product undergoing abridged assessment the fee is US$ 8000.
Change assessment fee
WHO will review the change documentation submitted by the manufacturer to determine the type and level of assessment required which, in turn, will determine whether the change assessment fee of US$ 3000 will be charged. The change assessment fee is waived in certain cases. WHO does not charge fees for the assessment of administrative changes and for certain abridged reviews. WHO determines the applicability of a waiver on a case-by-case basis.
An annual fee of US$ 4000 is levied for each product listed on the WHO List of Prequalified In Vitro Diagnostics. An invoice for the annual fee will be issued by WHO to the manufacturer on or before 1 October of each year. The annual fee is applicable to all IVDs that, by 1 September of that year, have been listed for 12 months or more. Payment of the annual fee must be made before 30 November of the calendar year in which the invoice is issued.