As the WHO introduces significant reforms to its prequalification programme in 2026, understanding the evolving requirements has become essential for manufacturers seeking access to global health markets.
For Indian IVD companies targeting global procurement through UNICEF, Gavi, The Global Fund, or PEPFAR, understanding these changes is no longer optional.
Inside this whitepaper, you’ll find:
- What WHO-PQ is and why it matters for global market access
- 2026 reforms - what changed and what it means for you
- Step-by-step IVD application process
- Full vs. Abridged pathway, eligibility criteria
- Timelines, costs, and post-prequalification obligations
- Post-market obligations post-listing
- Strategic guidance specifically for Indian MSMEs and startups
Whether you are an IVD manufacturer, MedTech startup, regulatory affairs professional, or quality leader, this guide offers actionable insights to help you navigate the WHO-PQ journey with confidence.