Why participate?

Obtaining prequalification of an in vitro diagnostic (IVD) or male circumcision device (MCD) requires investment in both funding and staff time  (to improve production quality and/or to prepare a dossier for submission and deal with any requests for further information from WHO). However the process delivers significant  benefits during and after product prequalification. 

Strengthening technical capacity 

The landscape for IVDs is complex: from development and manufacturing to regulatory requirements.  Participating in WHO’s prequalification of IVDs  assessment helps manufacturer  understand how to meet international standards for quality-assured production of IVDs.  

Through WHO’s published guidance, direct feedback during dossier assessment, site inspection and labelling review, manufacturers gain valuable insight into best practices for regulatory compliance and quality management.  Manufacturers often report that one-to-one meetings with WHO assessors, such as those that take place before submission of a product dossier, are particularly helpful. 

By engaging in WHO prequalification, manufacturers can

• further develop their human resources for ensuring and managing quality manufacture
• enhance their capacity to ensure quality manufacture across their range of products
• increase or develop new capacity to understand and meet stringent regulatory requirements.

Expanding market access

WHO Prequalification is used by UN agencies, non-UN donor agencies, procurement agents and some low- and middle-income countries to guide their procurement of IVDs. Prequalified products are often prioritized in donor-funded tenders and procurement processes.

Having prequalified products also enhances a manufacturer’s reputation for quality and may facilitate preparation to enter into more strictly regulated markets, as well as create opportunities for local contract manufacturing.

Additionally, the WHO Collaborative Procedure for Accelerated Registration  for prequalified IVDs offer manufacturers the possibility of getting their products onto markets in countries more quickly. 

Improved image or brand

WHO prequalification is a trusted and reputed symbol for safety, quality and performance across stakeholders. Manufacturers of prequalified products have reported improved brand image following prequalification, and that their employees have welcomed prequalification status.

Eligibility

Any manufacturer producing an eligible IVD or MCD may apply for WHO prequalification.

Information for manufacturers 

Key resources for prospective and current participants in WHO prequalification of IVDs and MCDs can be found in the main sections of this website:

• IVDs Under Assessment and MCDs Under Assessment ― summarize what products are currently under assessment
• WHO List of Prequalified IVDs and WHO List of Prequalified MCDs ― giving details of IVDs and MCDs that have been prequalified, including applicant and manufacturing site details
• IVDs Eligible for Prequalification and MCDs Eligible for Prequalification ― information on the IVDS and MCDs currently eligible for evaluation for prequalification
• Procedures and Fees for IVD Prequalification and Procedures and Fees for MCD Prequalification ― information on prequalification requirements application procedures
• Post-prequalification Procedures for IVDs and Post-prequalification Procedures for MCDs ― information on what an applicant must do to maintain prequalification status
• Prequalification Reports ― WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites that have passed WHO inspection
• Guidance Documents ― three types of guidance are available: WHO prequalification guidance (including sample dossiers); the WHO Technical Specifications Series and the WHO Technical Guidance Series
• Collaborative Procedure for Accelerated Registration ― describing an innovative WHO procedure that offers manufacturers the opportunity to get their products onto markets more quickly
• Support to Manufacturers ― describes the technical advice and specialized technical assistance available to manufacturers to help them work towards prequalification of their IVD or MCD
• Market Information ―with links to reports and sources that contain information (including prices and volume) about who is procuring what
• Emergency Use Listing  Procedure and Expert Review Panel for Diagnostics ― describing procedures other than prequalification for assessing products and which can facilitate market entry for manufacturers
• Key Contacts ― the key persons who can be contacted regarding different aspects of prequalification, or collaborative registration or technical assistance.

Before submitting an application for prequalification

NAll new applicants must contact WHO before submitting an application for evaluation of an in vitro diagnostic (IVD) or male circumcision device (MCD).

A pre-submission meeting is compulsory for first time applicants and strongly recommended for manufacturers submitting additional products. These meetings can be requested by emailing diagnostics@who.int

During the pre-submission meeting, WHO provides guidance on all aspects of the application process, including dossier format and content. Submitting a well-prepared dossier improves the likelihood of passing screening and significantly reduces the time to prequalification.

Pre-submission meetings are also available to current participants in the WHO prequalification programme. In some cases, WHO may recommend organizing technical assistance to help a manufacturer address specific issues or strengthen areas before submission.