#United States #MedTech #Jersey City #Market Access #Pure Global

Pure Global's Groundbreaking Flat-Fee Pricing Model in MedTech

In a significant advancement for the MedTech industry, Pure Global announced the introduction of the first flat-fee pricing model designed for comprehensive medical device market access. This initiative aims to facilitate regulatory compliance and clear cost structures for manufacturers seeking to enter key markets in Latin America and Asia.

Simplifying Market Entry

Traditionally, managing regulatory compliance across various markets can be a complicated and unpredictable endeavor for MedTech companies. The conventional approach often involves multiple costs, including annual representation fees combined with per-registration consulting charges, leading to potential surprises in expenses. By contrast, Pure Global’s model consolidates all necessary regulatory services into one annual fee, starting at just USD $2,000. This innovative pricing strategy covers essential markets such as Brazil, Mexico, Colombia, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam.

Leveraging AI for Efficiency

The introduction of this pricing model has been made possible by the implementation of Pure Global’s proprietary AI support tools. Early adopters of the model reportedly experienced a remarkable 50% reduction in the time required for dossier compilation, which significantly accelerates the market entry process. With this AI-driven approach, regulatory planning becomes less cumbersome and more straightforward, allowing companies to expedite their growth strategies.

Comprehensive Annual Coverage

The flat-fee pricing model includes several essential services:

• - AI-assisted dossier preparation and submission: Utilizing Pure Global’s AI Builder facilitates efficient documentation.
• - In-country regulatory representation: Pure Global acts as the local license holder, managing all communications with local health authorities.
• - Translations: Regulatory submissions are translated from English into the required local languages.
• - Post-approval support: The fee covers modifications and renewals after approvals, ensuring ongoing compliance.
• - Importer and distributor authorizations: Where applicable, these authorizations are included.
• - Post-market support: The model also offers surveillance and ongoing communication with health authorities.

DJ Fang, COO and Co-Founder of Pure Global, emphasized that the new pricing model will simplify regulatory workflows for medical device companies. This clarity allows firms to focus on strategic initiatives and market expansion, rather than being bogged down by the unpredictability of regulatory processes.

Flexible Contract Structures

The contracts associated with the flat-fee pricing model are traditionally set for three years but offer flexible options for one-year terms and early termination. This flexibility is particularly beneficial for companies with diverse product portfolios or those entering multiple markets simultaneously.

Transparent, Predictable Costs

Aside from the flat fee, which condenses all regulatory costs, certain government and third-party expenses remain excluded, such as import handling and certified translations. Companies with more complex regulatory needs can request tailored pricing arrangements. Additionally, an innovative Fee Calculator enables manufacturers to receive instant estimates of costs across various markets, further enhancing budget predictability.

Conclusion

With this revolutionary flat-fee pricing model, Pure Global seeks to remove friction from the global market access process. It aims to empower MedTech manufacturers by providing a clear and straightforward pathway to regulatory compliance across multiple international markets. By allowing companies to streamline their processes and focus on growth, Pure Global is positioning itself as a key player in the evolving landscape of medical device regulations globally.

For more information, please contact:
Alma Miftari at [email protected] or call +38 148110906.