Mitigating diseases which have significant societal impact starts with an early and accurate diagnosis. Ensuring access to safe, appropriate and affordable in-vitro diagnostics (IVDs) is a key step in improving treatment and reducing disease transmissions and associated deaths.

The diagnosis and mitigation of diseases plaguing underdeveloped countries are largely overlooked by the developed world. This challenge offers a unique opportunity for Indian IVD manufacturers to step up and enter international markets by leveraging the prequalification process for in vitro diagnostic products (IVDs) offered by the World Health Organization.

What is WHO Prequalification (WHO PQ) of IVDs Prequalification of in-vitro diagnostic devices was launched in 2010 by WHO and the process ensures a pool of prequalified suppliers who offer good quality IVDs to United Nations agencies such as WHO, UNICEF, UNDP and UNFPA as well as to procurement agencies in member states of WHO. WHO PQ aims to promote and facilitate access to safe, appropriate and affordable in vitro diagnostics of good quality equitably. The focus is on IVDs for priority diseases that are appropriate for use in resource-limited settings A Unique Opportunity for Original IVD Manufacturers to Dominate Global Market Share with WHO PQ Mr. Sinto Poulose, an IVD kit manufacturing and regulatory expert from IQZYME Medtech Pvt Ltd explains that WHO prequalification is a unique opportunity for Indian IVD manufacturers to elevate their products to international quality standards. "Only legal or original manufacturers of IVDs that are already commercially available in the market are eligible for the WHO prequalification process," he explains.

Since rebranded and Original Equipment Manufacturer (OEM) products are not accepted for WHO prequalification, indigenous IVD manufacturers in India have a distinct advantage in successfully qualifying their products.

However, Mr. Sinto Poulose cautions that navigating the WHO prequalification process is a complex and demanding task, requiring significant investments of time, finances, and resources.

Challenges Faced by IVD Manufacturers in Acquiring WHO Prequalification (WHO PQ) Approval.

The stringent assessment process and the significant initial and recurring costs associated with WHO prequalification pose major challenges for many indigenous manufacturers in Asia and Africa.

Indian IVD manufacturers, despite having access to high-quality raw materials, advanced production equipment, and international quality compliance, often struggle to complete WHO PQ due to a poor understanding of the process. Even when their products meet all compliance requirements, qualifying the manufacturing facility remains a major challenge.

Additionally, small and medium-sized manufacturers face difficulties in recruiting experienced professionals in regulatory and quality assurance, further hindering their growth and compliance efforts.

Why Government Support is Essential for WHO Prequalification The biggest challenge for IVD manufacturers in entering the WHO prequalification process is the significant financial burden it imposes. For a single product undergoing full assessment, the WHO prequalification fee is US$ 17,000, while an abridged assessment costs US$ 8,000. In addition, costs incurred in analytical and clinical performance evaluations range between US$ 60,000 to 100,000.

Schemes targeted to address specific challenges of the IVD industry would provide substantial benefits. Financial aid, subsidies, and partial reimbursement of costs related to WHO prequalification fees, product evaluations, and QMS certifications would empower Indian IVD manufacturers to expand into global markets.

A Step-by-Step Guide to WHO Prequalification for IVD Manufacturers Manufacturers can successfully meet WHO prequalification requirements with the right guidance and meticulous planning, says Mrs Selma Siyavudeen, quality and regulatory expert from IQZYME Medtech Pvt Ltd. "Whether following the full assessment or abridged assessment route, implementing critical improvements in product quality is an absolute necessity, she emphasizes.

Key Stages in WHO Prequalification The WHO prequalification process consists of three key stages: 1. Product Dossier Review - Manufacturers must submit a comprehensive dossier providing detailed evidence on product safety, performance, design and manufacturing.

2. Laboratory Performance Evaluation - Upon dossier acceptance, an independent WHO-listed laboratory assesses the IVD’s performance and operational characteristics using publicly available standard evaluation protocols.

3. Manufacturing Site Inspection – WHO conducts an on-site audit to verify compliance with ISO 13485:2016 and assess the manufacturer’s capability to reliably supply products to WHO member states.

WHO Prequalification (WHO PQ) Assessment Process The WHO prequalification assessment follows two distinct routes (a) full assessment and (b) abridged assessment.

For a full assessment, the manufacturer must undergo all the key stages of evaluation, including product dossier review, laboratory performance evaluation, and manufacturing site inspection.

The abridged assessment option is available only for products that have already been rigorously evaluated by recognized regulatory agencies such as the European Union, Health Canada, the Therapeutic Goods Administration (Australia), the Ministry of Health, Labour and Welfare (Japan), and the U.S. Food and Drug Administration (FDA). In this route, the manufacturer submits an abridged product dossier, summarizing essential details about its Quality Management System (QMS), product design, performance, and manufacturing process. WHO then considers the existing evidence on performance evaluation, manufacturing site inspection, and labelling review as part of the assessment.

Does CE Marking Help with WHO Prequalification? Mr. Soio George, an Ex EU Notified Body Auditor and IVDR regulatory expert from I3CGLOBAL Reghelps Pvt Ltd shares his perspective. "Yes, CE Marking under IVDR can support WHO Prequalification but it does not guarantee automatic approval. If a product has already undergone a rigorous evaluation by an EU Notified Body under IVDR 2017/746, it may qualify for an abridged WHO PQ assessment, reducing the need for extensive additional testing.

However, WHO still requires manufacturers to demonstrate the product’s performance in relevant global health settings. Even with a CE-marked device, compliance with WHO-specific requirements remains essential for successful prequalification." Mr. Soio George further emphasizes that WHO Prequalification does not replace CE Marking, as IVDR has stricter regulatory requirements, particularly concerning clinical evidence and post-market surveillance (PMS) compliance. However, a WHO-prequalified product with strong performance data may support the clinical evidence needed for IVDR certification.

Consultants for WHO PQ and IVDR CE Marking Navigating the stringent regulatory frameworks of WHO and the EU IVDR requires specialised and experienced professionals with a well-rounded exposure to production, quality, and regulatory affairs—an area where many manufacturers face significant challenges in finding suitable consultancy services In response to this growing need, I3CGLOBAL and IQZYME have entered a technical partnership to provide comprehensive regulatory support to manufacturers worldwide.

With 25 years of EU and US FDA experience and a team of over 75 permanent employees, I3CGLOBAL brings extensive regulatory expertise. IQZYME, with its strong background in production and quality in the IVD segment, has over 50 permanent employees and a panel of experts, including former CDSCO and WHO auditors. This collaboration forms a robust alliance capable of supporting IVD manufacturers in India and across the globe.

Through the I3CGLOBAL-IQZYME partnership, manufacturers will receive end-to-end assistance in key areas such as technical dossier preparation, risk assessment, performance evaluation, QMS implementation, and regulatory submissions, enabling them to successfully navigate global market approvals Conclusion The WHO Prequalification process enables IVD manufacturers to meet global standards and expand internationally. Manufacturers focused on quality and proper financial planning can benefit from the I3CGLOBAL-IQZYME partnership for faster WHO PQ and IVDR CE Marking approval (Disclaimer: The above press release comes to you under an arrangement with NRDPL and PTI takes no editorial responsibility for the same.). PTI PWR PWR