Pure Global Introduces Flat Fee Pricing for Medical Device Market Access

Pure Global has introduced a flat-fee pricing model that offers clarity and scalability across 13 major markets. This model includes AI-supported dossier compilation, in-country representation, and post-market support at a fixed annual cost per device. Along with Pure Global’s AI Builder dossier capabilities, the new pricing structure offers mobility to manufacturers with existing approvals who are seeking compliance in new markets.

Predictable Annual Fees, Starting at $2,000

Pure Global’s pricing starts at $2,000 USD per listing or device group per year (excluding government and third-party fees), with adjustments based on classification, number of listings, and selected markets. Companies can generate an instant cost estimate across multiple markets using Pure Global’s interactive Fee Calculator.

For organizations managing large portfolios of more than 10 listings or device groups, custom pricing is required to scope portfolio complexity and operational scale. Reach out to the Pure Global team for a custom quote.

What is Included in the Annual Fee?

The annual flat fee includes essential pre- and post-market regulatory activities required for successful registration and ongoing compliance:

• Dossier preparation and submission: Compilation and filing of regulatory dossiers using AI-enabled workflows and in-house regulatory expertise.

• In-country regulatory representation: Acting as the local legal representative and managing all regulatory correspondence with health authorities.

• Regulatory submission translations: Translation of required submission documents from English into the local language.

• Post-approval modifications and renewals: Preparation and submission of compliant filings for approved changes and periodic renewals.

• Importer and distributor authorization: Issuance of authorizations for local importers and distributors, where required.

• Post-market regulatory support: Ongoing support for post-market surveillance, vigilance activities, and authority communications.

These services are included for all eligible markets under the flat-fee structure, including:  

• Brazil

• Mexico

• Colombia

• European Union

• United Kingdom

• Switzerland

• Australia

• Hong Kong

• Indonesia

• Malaysia

• Singapore

• Thailand

• Vietnam

Additional markets are supported through customized pricing based on local regulatory requirements.

What Is Not Included in the Annual Fee?

What the flat annual fee does not cover:

• Government and third-party fees: These vary by country and must be paid separately.

• Import handling: Support with physical importation logistics is or can be quoted separately.

• Translations into English: Only translations from English to local languages are included.

• Certified translations: If a health authority requires notarized or certified translations, these are billed separately.

• Marketing material translations: Non-regulatory documents, such as brochures or promotional materials, are not included.

These exclusions are standard across the industry for regulatory representation, which usually does not include operational or commercial services.

Flexible Contracts with Clear Terms

All flat-fee agreements require a three-year commitment. However, companies can opt for a one-year contract with a higher first-year fee or terminate a three-year contract early by paying 50% of the remaining contract value.  

Designed for Regulatory Efficiency

Pure Global’s pricing model eliminates uncertainty from the regulatory budgeting process. By offering a single, annual fee that includes all core services, manufacturers get:

• Upfront cost visibility across multiple markets

• Faster planning cycles with instant pricing via the Fee Calculator

• Scalable support for portfolios ranging from one to ten devices

• Full-service regulatory execution, from pre-market to post-market

For medical device companies with existing approvals pursuing global expansion, this pricing model supports faster, more predictable market entry.

Get your instant global market access estimate.