QR Group warns of the impact of non-compliance with the requirements of RDC 36/2015 and guides companies on how to keep their records in compliance
In July 2025, ANVISA announced the cancellation of registrations of medical devices for in vitro diagnosis (IVD) that did not meet the deadline for sanitary reframing, established by RDC No. 36/2015. The measure directly impacts manufacturers and registration holders who failed to file the required adequacy within the schedule defined by the agency.
QR Group, a consulting firm specializing in health product regulation, analyzes the risks and consequences of non-reframing, and guides companies on how to regularize their products and avoid withdrawal from the market.
Why were the records canceled?
The cancellation was the result of non-compliance with the obligations provided for in RDC No. 36/2015, a rule that restructured the regulatory framework for in vitro diagnostic medical devices. The rule provided that all products previously regularized under old regulations should be reclassified according to the current classification and safety criteria, with a deadline of April 2024.
Products that have not gone through the reframing process have had their registrations canceled and can no longer be manufactured, imported, marketed or used in the national territory.
What are the risks for companies that did not meet the deadline?
Regulatory consequences of non-compliance include:
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Immediate loss of sanitary registration with ANVISA;
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Prohibition of marketing and distribution of the product in Brazil;
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Risk of tax actions and inventory recall;
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Damage to the company’s reputation in the regulated market.
In addition, companies that wish to keep the product on the market will have to start a new regularization process, with complete technical analysis under ANVISA’s current criteria.
How QR Group can help your company
QR Group acts strategically in the regularization and reframing of medical devices, offering:
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Technical analysis of the current regulatory status of the products;
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Consultancy for reframing according to RDC No. 36/2015;
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Support in completing and submitting reclassification petitions;
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Strategies for safe re-entry into the market, in case the registration has been canceled.
Our goal is to ensure that your company acts safely, quickly and within the rules, minimizing regulatory risks and avoiding commercial losses.
Talk to QR Group
Does your company have in vitro medical devices affected by ANVISA’s cancellation?
Talk to QR Group to reframe your products and ensure return to market with full compliance.
Source: ANVISA
