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Brazil's SaMD Gambit: Unlocking ANVISA's New Fast-Track with Pure Global.
This week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just launched a new resolution for Software as a Medical Device (SaMD), creating an unprecedented fast-track pathway for innovative digital health products. This move promises to slash approval times and attract global investment.
But there's a catch. While the new "fast-track" leverages existing international approvals, it also imposes stricter, more sophisticated requirements on technical documentation, cybersecurity, and clinical data relevance for the Brazilian population. This episode explores how savvy MedTech companies can seize this opportunity while avoiding the hidden pitfalls that could lead to rejection.
**Case Study:** A European AI-driven diagnostic software company, already holding a CE mark, has been planning its entry into Brazil. The new ANVISA resolution seems like a golden ticket to bypass the historically long review times. But will their existing technical file be enough? Are their cybersecurity protocols compliant with Brazil's specific data laws? We break down the critical gaps they must fill to turn this opportunity into a market reality.
**Key Questions Answered:**
- What are the specific criteria to qualify for ANVISA's new SaMD fast-track pathway?
- How can you leverage your existing FDA or CE marking approval for a faster Brazilian registration?
- What are the top three new documentation requirements that most companies will overlook?
- Why is adapting your clinical data to Brazilian demographics now non-negotiable?
- What specific cybersecurity vulnerabilities is ANVISA now scrutinizing more than ever?
- How has the role of the Brazil Registration Holder (BRH) evolved from a legal requirement to a strategic necessity?
Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.
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By Ran ChenThis week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just launched a new resolution for Software as a Medical Device (SaMD), creating an unprecedented fast-track pathway for innovative digital health products. This move promises to slash approval times and attract global investment.
But there's a catch. While the new "fast-track" leverages existing international approvals, it also imposes stricter, more sophisticated requirements on technical documentation, cybersecurity, and clinical data relevance for the Brazilian population. This episode explores how savvy MedTech companies can seize this opportunity while avoiding the hidden pitfalls that could lead to rejection.
**Case Study:** A European AI-driven diagnostic software company, already holding a CE mark, has been planning its entry into Brazil. The new ANVISA resolution seems like a golden ticket to bypass the historically long review times. But will their existing technical file be enough? Are their cybersecurity protocols compliant with Brazil's specific data laws? We break down the critical gaps they must fill to turn this opportunity into a market reality.
**Key Questions Answered:**
- What are the specific criteria to qualify for ANVISA's new SaMD fast-track pathway?
- How can you leverage your existing FDA or CE marking approval for a faster Brazilian registration?
- What are the top three new documentation requirements that most companies will overlook?
- Why is adapting your clinical data to Brazilian demographics now non-negotiable?
- What specific cybersecurity vulnerabilities is ANVISA now scrutinizing more than ever?
- How has the role of the Brazil Registration Holder (BRH) evolved from a legal requirement to a strategic necessity?
Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.