Post-prequalification requirements

In vitro diagnostics (IVDs) that meet WHO prequalification requirements are listed in the WHO List of Prequalified IVDs.  After Prequalification, manufacturers of prequalified IVDs must

• Fulfil prequalification commitments
• Conduct post-market surveillance
• Submit an annual reports
• Maintain compliance with relevant WHO Technical Specifications series documents
• Report any changes to the product after prequalification
• Pay an annual fee.

In addition WHO will undertake follow-up/surveillance inspections as part of post-qualification activities.

Each are described in detail in “Overview of WHO’s prequalification procedure for in vitro diagnostics” (WHO document PQDx_007). 
 

Fulfilment of prequalification commitments

It is the manufacturer's responsibility to fully address WHO's prequalification commitments arising from WHO’s prequalification assessment of the product (e.g., the product dossier review and/or labelling review) within the deadlines agreed with WHO.

Post-market surveillance

For each prequalified IVD, the manufacturer must conduct post-market surveillance to collect and analyse experiences with the use of the IVD and to determine any action to be taken. The manufacturer must monitor the prequalified product to ensure continued compliance with WHO’s prequalification requirements. 

Annual reporting

Manufacturer of a prequalified or a EUL-listed IVDs must submit to WHO an annual report for that product ‒ in a summarized form and in the format prescribed by WHO. The report must give production and sales details and information about any (all) categories of complaints received. See “Annual Reporting”

Ongoing compliance with technical specifications

The purpose of the WHO Prequalification Technical Specifications Series is to provide technical guidance to manufacturers of IVDs seeking WHO prequalification. Where WHO’s prequalification Technical Specifications Series documents for a specific product type eligible for WHO’s prequalification exist, manufacturers must comply with the requirements laid down in the relevant publication in this series. For products prequalified before the relevant publication is issued, a transition period will apply. 

Manufacturers must comply with the relevant technical specifications as outlined in the technical specification series within 3 years from their publication. Refer to the webpage TSS for the full list of published Technical Specification Series documents link here. 

Change reporting

For any planned changes to a prequalified product or the process by which it is manufactured, the manufacturer must determine its significance with respect to the function, performance, usability, safety and applicable WHO requirements for the prequalified IVD and its intended use. See "Changes to Prequalified IVDs". 

Payment of the annual fee

Manufacturers must pay a non-refundable annual fee for each product included on WHO’s list of prequalified in vitro diagnostics. Refer to the  guidance document PQDx_299 – “WHO’s Prequalification assessment fees“ for detailed information on fees and timing of payment.

Routine and non-routine re-inspection

Routine re-inspection is carried out to ensure continued compliance with prequalification requirements. Routine re-inspections typically take place every three and up to five years after prequalification of a product, unless an earlier re-inspection is deemed necessary by WHO. 

Non-routine manufacturing site inspections (also called follow-up or for-cause inspections) are triggered by specific events, concerns or findings (e.g., complaints, regulatory actions initiated by a regulatory authority) and are usually event-driven and focused in scope. The timing and scope of non-routine inspections will be determined by WHO on a case-by-case basis. 

Further information can be found on the WHO inspections service webpage link here. 

Link to guidance document: click here