ANVISA Confirms Continuity of Direct Imports via DDR
ANVISA has recently published the new Import Manual, confirming that the Declaration of the Registration Holder (DDR) will remain valid. This document allows the holder of a product registered in Brazil to authorize third parties to carry out direct imports, ensuring greater agility, flexibility, and legal certainty in operations.
In recent months, the industry had been concerned about potential regulatory changes, especially with the implementation of the Single Import Declaration (DUIMP) and new customs requirements. Many importers feared that the DDR would be discontinued or become more bureaucratic, leading to delays and increased costs. ANVISA’s confirmation has brought predictability and reassurance to companies and distributors, ensuring that this well-established model continues to function.
Although the DDR remains valid, companies must pay attention to certain adjustments. It is important to understand how it integrates with new electronic systems, such as DUIMP and LPCO, and to verify possible additional documentation requirements. Furthermore, alignment between registration holders, importers, and distributors remains essential to ensure efficient and compliant operations.
The maintenance of the DDR reinforces the stability of the regulated market, allowing already registered products to be imported in a practical and legal manner. For the sector, this means security, operational continuity, and greater predictability in imports, even in light of the changes introduced by the new Import Manual.
At Passarini Group, we closely monitor all updates in the regulatory market and ANVISA’s decisions, ensuring our clients have access to accurate, up-to-date information and specialized support to operate safely and efficiently in the regulated import sector.
To better understand all the changes and check details about the procedure, watch the explanatory video here.
To download the complete import manual (in Portuguese), click here.
Contact our experts and find out how we can accelerate your sanitary registration. Send an email to contato@passarini.com.br
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