Sign up to save your podcasts
Or
Share Unlocking Global MedTech Markets: Pure Global’s End-to-End Strategy for Launching in Brazil and Beyond
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
Unlocking Global MedTech Markets: Pure Global’s End-to-End Strategy for Launching in Brazil and Beyond
Navigating the complex world of global MedTech regulations can be a major challenge. Many companies find themselves juggling multiple local consultants, leading to duplicated work, inconsistent strategies, and costly delays. This episode of MedTech Global Insights dives into the powerful alternative: partnering with a single, end-to-end provider for global market access.
We explore how an integrated approach streamlines the entire product lifecycle, from initial classification and dossier submission to long-term post-market surveillance. Learn how centralizing your regulatory functions can not only accelerate your time-to-market but also significantly reduce compliance risks and operational costs, turning a complex necessity into a powerful strategic advantage.
Consider this scenario. A promising scale-up has CE marking for their innovative diagnostic tool and wants to launch in ten new markets. They are now facing the daunting task of hiring ten different local consultants, reformatting their technical dossier ten times, and trying to track ten separate submission timelines. This fragmented approach skyrockets costs and creates significant compliance risks. This episode explores the solution.
Key Takeaways:
* Why does using multiple distributors for registration often lead to hidden costs and compliance gaps?
* How can a "single source of truth" for your technical dossier accelerate submissions in markets from Mexico to Malaysia?
* What is regulatory ‘grouping,’ and how can it save you millions in submission fees?
* How can you leverage your existing FDA or CE approval to fast-track entry into new emerging markets?
* What are the critical post-market surveillance tasks that become unmanageable with a fragmented regulatory approach?
* How do integrated AI tools prevent common errors in dossier submissions to authorities like ANVISA or the SFDA?
* Is a single global provider more cost-effective than hiring local experts in each target country?
Contact us at [email protected] or visit https://pureglobal.com/.
View all episodes
By Ran ChenNavigating the complex world of global MedTech regulations can be a major challenge. Many companies find themselves juggling multiple local consultants, leading to duplicated work, inconsistent strategies, and costly delays. This episode of MedTech Global Insights dives into the powerful alternative: partnering with a single, end-to-end provider for global market access.
We explore how an integrated approach streamlines the entire product lifecycle, from initial classification and dossier submission to long-term post-market surveillance. Learn how centralizing your regulatory functions can not only accelerate your time-to-market but also significantly reduce compliance risks and operational costs, turning a complex necessity into a powerful strategic advantage.
Consider this scenario. A promising scale-up has CE marking for their innovative diagnostic tool and wants to launch in ten new markets. They are now facing the daunting task of hiring ten different local consultants, reformatting their technical dossier ten times, and trying to track ten separate submission timelines. This fragmented approach skyrockets costs and creates significant compliance risks. This episode explores the solution.
Key Takeaways:
* Why does using multiple distributors for registration often lead to hidden costs and compliance gaps?
* How can a "single source of truth" for your technical dossier accelerate submissions in markets from Mexico to Malaysia?
* What is regulatory ‘grouping,’ and how can it save you millions in submission fees?
* How can you leverage your existing FDA or CE approval to fast-track entry into new emerging markets?
* What are the critical post-market surveillance tasks that become unmanageable with a fragmented regulatory approach?
* How do integrated AI tools prevent common errors in dossier submissions to authorities like ANVISA or the SFDA?
* Is a single global provider more cost-effective than hiring local experts in each target country?
Contact us at [email protected] or visit https://pureglobal.com/.