The innovative pricing model offers predictable, transparent costs for regulatory registration and market access across key markets in Latin America and Asia.
Jersey City, 3 February 2026: Pure Global launches the first flat-fee pricing model in the MedTech industry for full-service medical device market access, designed to simplify regulatory compliance and provide transparent costs for manufacturers expanding into global markets.
This pricing model covers major markets in Latin America and Asia, including Brazil, Mexico, Colombia, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam, and consolidates all essential regulatory services into a single annual fee per registration, starting at USD $2,000.
The flat-fee pricing is made possible with the support of in-house developed AI support tools, with early adoption already delivering over 50% reduction in dossier compilation time, accelerating market entry, and making regulatory planning straightforward. Standard agreements are structured as three-year contracts, with options for one-year terms or early termination for added flexibility.
The launch addresses a key challenge for MedTech companies: budgeting for regulatory compliance across multiple markets is often complex and uncertain. Traditional approaches typically combine annual representation fees with per-registration consulting charges and variable post-market follow-up costs, which can lead to unexpected expenses. Pure Global’s flat-fee model consolidates pre- and post-market services into a single, all-inclusive annual cost, eliminating this variability.
The annual fee includes:
AI-assisted dossier preparation and submission using Pure Global’s proprietary AI Builder.
In-country regulatory representation, acting as the local license holder and managing all communications with health authorities.
Post-approval modifications and renewals.
Importer and distributor authorizations, where required.
Ongoing post-market support, including surveillance and authority communications.
“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 & 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. This approach lets teams focus on strategy and growth rather than navigating unpredictable regulatory processes.”
Excluded from the fee are government and third-party charges, import handling, certified translations, and marketing materials. Companies with larger portfolios or more complex regulatory needs can request custom pricing, while an interactive Fee Calculator allows manufacturers to generate instant cost estimates across multiple markets.
By consolidating regulatory services into a transparent, all-inclusive annual fee, Pure Global aims to reduce friction in global market access and empower MedTech manufacturers to focus on growth while ensuring compliance across multiple international markets.
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For more information, contact:
Alma Miftari alma@prlab.co | +381 48 110 906
You can find the press kit here.
About Pure Global
Pure Global is a medical device regulatory consulting firm with 15+ offices across five continents, supporting medical device and IVD companies with global market access, medical device registration strategy, and ongoing regulatory compliance. Pure Global operates across key markets, including the United States, European Union, Brazil, Mexico, Colombia, and ASEAN, providing guidance from local regulatory specialists to streamline market entry and maintain compliance worldwide.