Overview
The National Health Surveillance Agency (ANVISA) has published two documents on the new rules for post-market monitoring of cosmetics. The Inspection Manual for Good Cosmetic Surveillance Practices and the Questions and Answers on RDC 894/2024 will support the implementation of the new regulatory guidelines and strengthen the safety of cosmetic products in Brazil.
Introduction
ANVISA the National Health Surveillance Agency recently published two key documents for the Brazilian cosmetics sector: the Inspection Manual for Good Cosmetic Surveillance Practices and the Questions and Answers on RDC 894/2024. These documents are intended to support the implementation of the new regulatory guidelines aimed at strengthening cosmetics safety in Brazil, as well as ensuring greater protection for public health.
The Inspection Manual, aimed at professionals in the National Health Surveillance System (SNVS), offers clear and detailed guidelines for carrying out health inspections within the scope of cosmetovigilance. Developed with the collaboration of state and municipal health surveillance agencies, the document seeks to standardize inspection practices and ensure greater standardization in regulatory and health inspection activities.
What changes with RDC 894/2024
RDC 894/2024, which deals with the post-market monitoring of cosmetic products, comes to formalize safety and surveillance practices for products already available on the market. It stipulates that manufacturers, importers and distributors of cosmetics must create and maintain cosmetovigilance systems, i.e. continuous processes for monitoring the safety of products after they have been marketed. This is essential to identify and mitigate possible risks to consumers’ health, ensuring that products fulfill their promises of safety and efficacy.
The Good Cosmetic Surveillance Practices Inspection Manual
The Good Cosmetic Surveillance Practices Inspection Manual is one of the main tools created by ANVISA to support companies in complying with the requirements of RDC 894/2024. This manual offers detailed guidance on how those responsible for marketing cosmetics should organize their post-market monitoring systems, how to identify and analyses adverse events and how to notify ANVISA in the event of product-related risks.
The manual is a practical guide that facilitates the implementation of good cosmetovigilance practices, from the creation of monitoring protocols to the collection and analysis of product information. It also provides guidance on the documentation and requirements for reporting risks to ANVISA, a fundamental step so that the agency can act quickly if a safety problem is identified.
Questions and Answers on RDC 894/2024
In addition to the manual, ANVISA has also made available a Q&A document on RDC 894/2024, which clarifies frequently asked questions from companies and professionals in the sector. This document aims to eliminate ambiguities and provide clear information on companies’ obligations, the procedures for reporting adverse events, the criteria for risk assessment, among other important points.
Among the main points covered are the definitions of “adverse event”, the deadlines for reporting events, how to collect data and the responsibilities of the different parties involved in the cosmetics supply chain.
Impact on Companies and Consumer Safety
With the publication of the Good Cosmetic Surveillance Practices Inspection Manual and the Questions and Answers document on RDC 894/2024, ANVISA has taken another important step towards strengthening the safety of cosmetic products in Brazil. The new rules demand greater responsibility from companies, but also guarantee more protection for consumers, ensuring that the sector continues to grow in a safe and reliable manner. Adapting to these new guidelines is essential for the Brazilian cosmetics industry to remain competitive in the global market, while ensuring the health and well-being of its consumers.
Conclusion
ANVISA’s clinical research database is a fundamental step towards ensuring greater transparency and quality in the development of medical devices in Brazil. The initiative is an invitation to collaboration between all players in the health sector, promoting innovation and safety for the Brazilian population.
The clinical investigational data for the Brazilian market is welcome and coincides with the release of clinical investigational data in Europe. In Europe, the Clinical Investigation Reports (CIR) were published in the European CIRCABC (November 30).
In addition, Health Canada now makes clinical information available on Class III and Class IV medical devices (Public Disclosure of Clinical Information).
The actions of these regulators indicate recognition of the importance of disclosing this investigational clinical data.
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
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Email: info@globalregulatorypartners.com
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References
Learn more about Anvisa. For the link, click here
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.