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 quest for minimally invasive aesthetic procedures is growing exponentially in Brazil, driving innovation in both the cosmetics and health product sectors. However, this expansion is accompanied by a critical regulatory challenge: the improper use of products. ANVISA has recently demonstrated an uncompromising focus on inspecting and prohibiting companies that market cosmetics and personal hygiene products as injectable substances.
This practice not only violates current sanitary legislation but also severely risks the health of thousands of consumers. ANVISA’s recent actions serve as a stern reminder that a product’s intended use—whether it is an external-use cosmetic or an injectable medical device—is the foundation of all regulatory compliance and safety.
Key Aspects of this News for the Regulated Sector
- ANVISA’s Alert and Direct Prohibition (Multisectoral Impact)
ANVISA has been proactive, issuing suspension resolutions, interdictions, and sanitary alerts. The main focus has been on products classified as cosmetics that are improperly used or promoted for injectable (subcutaneous) purposes, which is strictly prohibited in Brazil.
This is a multisectoral issue, impacting:
- Cosmetics Sector: Products with simplified registration or notification for topical use are being diverted for invasive use.
- Medical Devices/Medicines Sector: The irregular use of cosmetics competes with legally registered injectable medical devices and medicines, which have undergone rigorous testing for safety and efficacy for internal use.
- The Regulatory Basis: Clear Distinction of Intended Use
The core of this issue lies in the correct product classification and intended use:
Category | ANVISA Definition (Focus) | Crucial Requirements |
Cosmetics | External Use (surface of skin, hair, nails, etc.), for protection, beautification, or hygiene. | Notification/Registration (risk-based), RDC 907/2024, GMP (RDC 48/2013). Cannot be injected. |
Medical Devices | Diagnosis, prevention, monitoring, treatment, or replacement of anatomy/function. Includes materials and substances for injectable and invasive use. | Mandatory Registration (high risk), Good Manufacturing Practices Certification (CBPF/GMP), RDC 665/2022. |
A cosmetic product does not meet the necessary sterility, purity, and biocompatibility requirements for injection into the human body—a distinction that only approval as a Medical Device (or medicine) can guarantee.
- The Strict Enforcement of Good Manufacturing Practices (GMP)
ANVISA’s actions go beyond prohibiting injectable use. The agency has reiterated the importance of full compliance with Good Manufacturing Practices (GMP). Cases of interdiction and product recall (cosmetics and sanitizing products) due to failures in GMP (as per RDC 48/2013, for example) demonstrate that the Agency is actively inspecting production compliance, from raw material to finished product. Non-compliance with GMP results in severe sanctions, such as the prohibition of manufacturing and commercialization for the company’s entire product line.
Conclusion
A Call for Regulatory Accountability
ANVISA’s recent wave of enforcement is a vital wake-up call for the regulated sector. The Brazilian market demands that companies maintain regulatory compliance as their highest priority.
For manufacturers, importers, and distributors of cosmetics and health products, this is the time to:
Portfolio Review: Ensure that the classification and registration of every product (Cosmetic, Medical Device, or Medicine) are 100% accurate and aligned with the approved intended use.
GMP/CBPF Rigor: Invest in the maintenance and documentation of Good Practices, ensuring production quality and safety.
Communication Transparency: Avoid any advertising or promotion that induces off-label (outside the approved indication) use of the products.
By maintaining regulatory compliance, companies protect consumers, avoid financial losses from interdictions, and reinforce the credibility and longevity of their businesses in Brazil.
GRP Brazil Highlight Note
Highlight: Navigating the complexity of Brazilian sanitary legislation, especially in the areas of GMP, classification, and product registration (cosmetics, medical devices, and medicines), requires specialized expertise. GRP Brazil acts as a strategic partner, providing Regulatory Intelligence and comprehensive technical support to ensure your company is in full compliance with ANVISA’s requirements, turning regulatory challenges into business success and safety. Don’t take risks; invest in compliance.
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.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
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.