Pure Global has introduced what it calls the first flat-fee pricing model for full-service medical device market access. The new structure replaces traditional variable costs with a single annual fee per registration, starting at $2,000.
The model covers regulatory services across nine markets in Latin America and Asia, including Brazil, Mexico, Colombia, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam. Companies pay one predictable cost that includes pre-market registration, post-market compliance, and regulatory representation.
Traditional regulatory consulting typically combines annual representation fees with per-registration charges and variable post-market costs. This creates uncertainty when budgeting for multi-market expansion.
Pure Global's approach consolidates these services into one annual fee. A manufacturer registering a single Class II device in Brazil pays $2,000 per year. Three products cost $4,000 annually, and five products run $6,000. The company offers a fee calculator on its website that generates instant cost estimates based on product count and classification.
Standard agreements run for three years, though one-year terms and early termination options are available. Government fees and third-party charges remain separate but are clearly listed in the calculator.
The annual cost covers several core services. Pure Global handles dossier preparation and submission using its proprietary AI Builder tool. The company acts as the in-country regulatory representative and local license holder, managing all communications with health authorities.
Regulatory submission translations from English into local languages are included. So are post-approval modifications, renewals, and importer or distributor authorizations where required. Ongoing post-market support covers surveillance activities and authority communications.
Items not covered include government and third-party charges, import handling, certified translations, and marketing materials. Companies with larger portfolios or complex regulatory requirements can request custom pricing.
Pure Global says its AI support tools have reduced dossier compilation time by over 50%. The technology standardizes submissions and accelerates market entry, making the flat-fee structure financially viable.
"Our flat-fee model uses AI to simplify regulatory workflows, giving medical device companies clear costs and faster access to global markets," said DJ Fang, COO and Co-Founder of Pure Global. "It supports both first-time product launches and complex multi-market portfolios by reducing administrative work, standardizing submissions, and providing ongoing compliance."
The approach aims to shift the focus from navigating unpredictable regulatory processes to strategic planning and growth. Whether this pricing model gains traction will depend on how well it scales across different device classes and regulatory complexities.
Pure Global operates as a medical device regulatory consulting firm with more than 15 offices across five continents. The company supports medical device and IVD manufacturers with market access strategy, registration services, and compliance management.
Its coverage spans the United States, European Union, Brazil, Mexico, Colombia, and ASEAN markets. The firm provides guidance from local regulatory specialists to help companies enter new markets and maintain compliance.
