Pure Global unveils flat-fee model for device approvals

Pure Global has launched a flat-fee pricing model for full-service medical device market access, charging an annual fee per registration starting at $2,000 in selected markets in Latin America and Asia.

The approach departs from common regulatory consulting fee structures, where manufacturers often pay a mix of annual representation charges, per-registration consulting fees, and variable post-market costs. Pure Global says the new model bundles services typically billed separately and makes budgeting for multi-country submissions more predictable.

At launch, the model covers Brazil, Mexico, Colombia, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam. It is aimed at manufacturers operating across Latin American and Asian jurisdictions, including those managing multi-market portfolios.

What is included

The annual flat fee covers dossier preparation and submission using AI-assisted tools, in-country regulatory representation, and translations for regulatory submissions from English into local languages. It also includes post-approval modifications and renewals, plus importer and distributor authorisations where required.

The bundled scope also includes ongoing post-market support, such as surveillance activities and communications with health authorities. Pure Global also acts as the local licence holder and regulatory representative in-country, handling communications with regulators.

Some costs remain outside the flat fee, including government and third-party charges, import handling, certified translations, and marketing materials.

Manufacturers with larger portfolios or more complex regulatory requirements can request custom pricing. Pure Global also offers an interactive fee calculator that generates cost estimates across multiple markets.

AI workflow

Pure Global links the pricing model to internal software it calls AI Builder. The tools support dossier compilation and submission preparation, which the company says reduces time spent assembling regulatory documentation.

According to Pure Global, early adopters have reduced dossier compilation time by more than 50%, shortening preparation work and enabling teams to move faster through the early stages of registration planning.

"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, Chief Operating Officer & Co-Founder at 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," Fang said.

Contract options

Standard agreements run for three years. Pure Global also offers one-year terms and early termination options.

The contract structure reflects an effort to balance recurring compliance work with manufacturers' changing portfolios, which can include new registrations, renewals, and post-approval changes. Medical device makers often maintain several product lines and manage multiple authorised importers and distributors, which can vary by country and over time.

Flat-fee approaches are common in other professional services but are less established in medical device regulatory consulting, where scope can change with product classification, local evidence requirements, and post-market obligations. Pure Global says its model combines pre-market and post-market work into a single annual charge, while excluding pass-through fees such as government charges.

The company plans to offer the flat-fee model across the listed Latin American and Asian markets, with custom pricing available for larger portfolios and more complex regulatory needs.