Overview
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Introduction
The Brazilian regulatory landscape for health products is undergoing a period of intense modernization. ANVISA has been actively working to reduce bureaucracy, increase predictability, and, crucially, promote convergence with major international practices. Two recent developments confirm this transformation: the publication of RDC 848/2024, which establishes a new standard for Medical Devices, and the release of the 2024-2025 Regulatory Agenda (AR), which defines the Agency’s work compass for the next two years. For the regulated sector, these acts represent both a challenge for adaptation and a significant opportunity for optimization and expansion.
Aspects of this News
The New Regulatory The New Framework for Medical Devices: RDC 848/2024.
The Collegiate Board Resolution (RDC) 848/2024, which replaces RDC 546/2021, is the key safety and performance framework for the Medical Device and IVD (In Vitro Diagnostic Medical Device) sector.
International Alignment (IMDRF): The primary significance of this RDC is its adoption of the essential safety and performance principles from the IMDRF (International Medical Device Regulators Forum). This move facilitates the use of technical analyses and documents for companies operating globally, aligning Brazilian requirements with the standards of more mature markets.
Focus on Safety and Performance: The regulation reinforces that products must meet the performance intended by the manufacturer, be safe for the intended use, and have acceptable risks compared to the benefits.
Simplification and Competitiveness: In a complementary initiative, ANVISA recently unified the petition codes for the Good Manufacturing Practices Certification (CBPF/GMP) of Medical Devices. This simplification reduces bureaucracy, improves efficiency, and strengthens the competitiveness of the sector.
The Strategic Compass: The 2024-2025 Regulatory Agenda
The publication of the Regulatory Agenda (AR) is a tool for transparency and predictability. The AR 2024-2025 details 172 priority regulatory topics, covering all macro-areas under sanitary surveillance.
Essential Predictability: By signaling what will be regulated in the coming years, ANVISA allows companies to anticipate, plan resources, and actively participate in Public Consultations.
Sectoral Highlights in the Agenda:
Cosmetics: Foreseen revision of the Cosmetovigilance regulation and update of the lists of permitted substances (filters, preservatives, etc.), with restricted or prohibited use.
Medicines: The agenda addresses the revision of the regulation for Medicinal Cannabis Products and the review of Good Pharmacovigilance Practices.
Health Products: In addition to the new RDCs, the AR includes the regulation of requirements for the regularization of products intended for aesthetic procedures with dermal action and the topic of reprocessing reusable health products.
Conclusion
Preparation and Regulatory Intelligence
ANVISA’s recent regulatory moves indicate a path towards technical debureaucratization, greater international convergence, and a commitment to predictability. RDC 848/2024 raises the technical standard, while the 2024-2025 Regulatory Agenda offers a clear vision of future changes.
For companies, compliance is no longer just an obligation, but a strategic asset. Staying ahead of changes, especially in the technical areas of medical devices and the sectoral revisions within the schedule is essential to guarantee the maintenance of registrations and explore new market opportunities in Brazil.
GRP Brazil Highlight Note Highlight: Alignment with the IMDRF and constant revisions by ANVISA demand more than just tracking regulations. GRP Brazil offers the specialized Regulatory Intelligence your company needs to interpret and implement the requirements of RDC 848/2024 and proactively prepare for the topics in the 2024-2025 Regulatory Agenda. Rely on GRP Brazil to ensure technical compliance, optimize your registration processes, and accelerate market access in Brazil with security and predictability.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.