QR Group analyzes the effects of the proposal to update the main rule that regulates the import of products subject to health surveillance in Brazil
In 2024, ANVISA began the process of revising RDC No. 81/2008, a rule that for more than 15 years has established the requirements for importing products subject to health surveillance, such as medicines, medical devices, food, cosmetics, and sanitizers. The measure is part of the agency’s regulatory agenda and aims to modernize the legal framework, aligning it with international guidelines and changes in the sector.
QR Group, a specialist in health product regulation, analyzes the main points of the review and guides importing companies on how to prepare for the new regulatory scenario.
Why is RDC 81/2008 being revised?
Published in 2008, RDC No. 81 consolidated import procedures, documentary requirements and sanitary criteria. Since then, the international trade of products subject to health surveillance has evolved significantly — with new logistics models, equivalence agreements, and regulatory technologies.
The proposed revision aims to:
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Update import requirements, with greater clarity and predictability;
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Reduce bureaucratic obstacles and analysis times;
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Strengthening technical criteria based on health risks;
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Harmonize the Brazilian regulatory framework with international practices, such as those of Mercosur and the WHO.
The public consultation is scheduled for the coming months, and the participation of companies and entities in the sector will be fundamental for the improvement of the standard.
What are the impacts on importing companies?
The revision of RDC 81/2008 may have a direct impact on the routine of companies that import health products:
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Changes in the documents required in the import petition processes;
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New criteria for analysis by risk and product category;
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Possible creation of more agile licensing mechanisms for lower-risk products;
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Greater demand for document compliance and traceability of operations.
Companies that act in a preventive and up-to-date manner will have competitive advantages by quickly adapting their processes to the proposed changes.
How QR Group supports companies in adapting to the changes of RDC 81
With consolidated experience in regulated importation and technical dialogue with ANVISA, QR Group offers:
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Monitoring and analysis of proposals for revision of the standard;
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Adjustment of internal processes and document routines;
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Technical support in petitioning, regularization and release of imports;
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Strategies to mitigate regulatory risks during the regulatory transition period.
Our goal is to ensure that your products arrive in Brazil safely, predictably and fully compliant.
Talk to QR Group
Does your company import products subject to health surveillance? Count on QR Group to anticipate the changes of RDC 81/2008 and maintain your regular operations with ANVISA.
