For some manufacturers, meeting WHO prequalification requirements can be challenging. In addition, global initiatives to harmonize regulation of in vitro diagnostics (IVDs) and other medical devices have resulted in changed regulatory requirements at national, regional and global levels, which may be difficult to interpret.

WHO can assist manufacturers by providing specialized technical assistance to:

• help recipients understand WHO prequalification requirements and how to meet them
• identify any major shortcomings in achieving compliance with international regulatory norms and standards.

Who is eligible?

Technical assistance is restricted to manufacturers of IVDs for WHO priority diseases and that have a high public health impact (e.g. self-tests, point-of-care tests, and/or tests adapted and suitable for the different health care levels in low- and low-middle income countries). These manufacturers include:

• any manufacturer who has made a pre-submission to WHO prequalification but whose product did not pass pre-submission screening
• manufacturers who have submitted an IVD to the Expert Review Panel for Diagnostics (ERPD) for risk assessment
• under certain circumstances, manufacturers of innovative products that are still under research and development stage; the products concerned are reviewed on a case-by-case basis.

How is specialized technical assistance initiated?

Specialized technical assistance may be initiated by WHO's Local Production and Assistance Unit (LPA):

1. After a request has been made by an IVD prequalification assessor following product dossier review or by a prequalification inspector following manufacturing site inspection.
2. When the ERPD secretariat informs LPA about a manufacturer that manufactures  a product of interest to procurers, which has the potential to deliver significant public health benefit, but which does not yet meet ERPD requirements for categorization as eligible for procurement.
3. A manufacturer of a product that is within the scope of IVD prequalification contacts LPA to request specialized technical assistance.

What is expected from the manufacturer?

Potential recipients are expected to:

• declare their intent to submit their IVD product to WHO prequalification after the necessary improvements have been implemented
• be transparent regarding any similar technical assistance that is being or will be provided by other organizations or under donor-driven projects
• designate a focal point for communication with LPA regarding the technical assistance visit that will be organized and coordinate all aspects of the visit, including follow-up activities, if needed
• facilitate the visit of the technical assistance expert(s), by providing: administrative support (in the form of an invitation letter) for visa applications; transportation between the relevant site and accommodation; provision of a modest lunch/refreshments and a small meeting room for team discussions and/or review of documents on the days of site visits; translation of relevant documents, if required
• provide the technical assistance expert(s) with the necessary information and documentation before, during and after the technical assistance visit
• agree to WHO making public their names as recipients of technical assistance 
• provide WHO with an evaluation of the conduct and usefulness of the technical assistance provided.

How is technical assistance provided?

After mutual agreement between WHO and the manufacturer on the product(s) to be covered has been reached, a two- or three-day gap analysis visit is planned at the manufacturing site by a group of experts, including quality management system specialists and product-specific laboratory technical experts. If appropriate, the national regulatory authority (NRA) may be invited to participate in or observe the visit.

During the gap analysis visit, the entire workstream flow — from incoming goods to outgoing IVDs — is followed and assessed. If needed, particular workflow elements may be assessed in depth. By the end of the visit, the manufacturer will have gained a good understanding of which manufacturing processes are compliant with prequalification and regulatory requirements and those that require improvement. The gap analysis report will guide the manufacturer as to what action must be taken in order to achieve full compliance with regulatory requirements.

Generally a manufacturer can implement many of the improvements indicated without assistance from external parties. However, in some instances, the manufacturer may be advised to contract external expertise, relating, for example, to development of the product dossier, product quality control, analytical and/or performance studies, or the manufacturing processes and procedures of the production plant and/or warehouses.

Care is taken to avoid any conflict of interest with WHO prequalification or with other sites receiving technical assistance. Technical assistance experts who have provided, or are providing, technical assistance to a recipient are not be permitted to participate in any assessment or inspection for WHO prequalification of the IVD manufactured by that recipient.

Site inspections and evaluations of product dossiers performed for WHO prequalification are independent of the outcomes of technical assistance. Information gathered during  provision of technical assistance is not shared with WHO prequalification staff and remains confidential.

Technical assistance is provided free of charge, although recipients may be requested to contribute towards the local costs associated with the visits of technical assistance experts, as described above.

Provision of technical assistance to a manufacturer may be combined with capacity building of other parties. For example, the NRA may participate in or observe the visit of the technical assistance expert(s).

WHO ensures that the confidentiality of commercially-sensitive and other information obtained during a technical assistance visit is respected. The observations and recommendations of the technical experts are shared with the recipient. Any information obtained during the provision of technical assistance can be made available to third parties only with the recipient's consent.

WHO reserves the right to request additional information from the organization that has requested assistance and to decide whether to meet the request.