Case Study: SprintRay accelerates Brazilian medical device approval with Emergo by UL

SprintRay obtains ANVISA approval in 2 months with Emergo

SprintRay, an innovative digital dental device manufacturer, faced significant challenges in expanding into the Brazilian market. The company needed to navigate complex regulatory requirements, find a reliable local authorized representative, and manage language barriers to obtain approval from ANVISA. To overcome these hurdles, SprintRay engaged Emergo by UL to act as its Brazil Registration Holder and manage the entire product registration process.

Emergo by UL provided a comprehensive solution, delivering a clear strategy, translating technical documents, and managing all communications with ANVISA on SprintRay's behalf. The vendor successfully obtained approval for three of SprintRay's products within just four months, with one amendment completed in only two months. This accelerated time to market was a direct result of Emergo by UL's expertise, which boasts a documented success rate of over 90% for device approvals in Brazil.

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