Life Sciences – In Focus delivers an insightful conversation with Stephanie Moreta, a regulatory affairs expert from Vera Rosas, one of Brazil’s leading consulting firms in medical device regulatory compliance. With over 15 years of experience in regulatory affairs, quality auditing, and medical devices, Stephanie shared valuable insights into the complexities of bringing high-risk medical devices to the Brazilian market.
Understanding Brazil’s Regulatory Challenges
Brazil’s health regulatory agency, ANVISA, is known for its rigorous standards and complex approval processes. Stephanie highlighted some of the most pressing challenges companies face when introducing medical devices into the market, particularly the classification system and unpredictable approval timelines.
Medical devices in Brazil are divided into four risk classes:
- Class I & II: A simplified notification process, with approvals typically granted within 30 days.
- Class III & IV: A more comprehensive registration process requiring a full technical dossier, including clinical evaluations and performance assessments. These approvals can take considerably longer.
One of the most significant hurdles for companies is the lack of predictability in regulatory reviews. Stephanie explained that different ANVISA reviewers might assess the same document differently, leading to inconsistencies and potential delays.
Strategies for Success in Brazilian Regulatory Affairs
For companies looking to navigate ANVISA’s stringent requirements, Stephanie emphasized the importance of local expertise. Vera Rosas helps companies with:
- Regulatory Checklists – Detailed guidance on required documentation, helping clients avoid common pitfalls.
- Direct Manufacturer Meetings – Clarifying compliance requirements before submission.
- Local Legal Representation – Finding a trusted partner in Brazil is crucial, as companies must have a legal representative to operate in the country.
Stephanie also stressed the need for companies to stay up-to-date with evolving regulations. While major regulatory changes are infrequent, Brazil has undergone several updates in the past three years, making it essential for businesses to proactively monitor ANVISA’s channels for updates.
The Future of Regulatory Harmonization in Brazil
A major positive development in Brazil’s regulatory landscape is its harmonization efforts with global standards. ANVISA is a member of IMDRF (International Medical Device Regulators Forum) and aligns its requirements closely with the U.S. FDA and the European Union.
A recent regulatory advancement, Normative Instruction IN 290 (April 2024), introduces an optimized pathway for product approvals, known as the Reliance Route. This allows companies with prior approvals from recognized regulatory agencies (e.g., Japan, Canada, Australia, and the U.S.) to benefit from a faster and more predictable approval process in Brazil.
Language and Compliance Considerations
Companies planning to submit regulatory documentation to ANVISA should be aware of language requirements. Brazil accepts documents in English, Spanish, or Portuguese, but legal documents (such as authorization letters) may require apostille or consularization if not in one of these languages.
Final Thoughts
Bringing innovative medical devices to the Brazilian market is a complex but rewarding process. With expert guidance, companies can successfully navigate regulatory hurdles and contribute to the advancement of healthcare in Brazil.
As Stephanie concluded, partnering with a trusted regulatory consulting firm like Vera Rosas is key to ensuring compliance and accelerating market access.
About Life Sciences – In Focus
Life Sciences – In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences – In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences – In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.
About Vistatec
We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com