Understand How the Regulation Update Affects the Import of Health Products and How QR Group Assists Companies in the Process

On May 15, the National Health Surveillance Agency (ANVISA) approved the Regulatory Impact Analysis Report (RAIR) regarding the revision of the Technical Regulation of goods and products imported for health surveillance purposes. This step represents a fundamental step in the revision of RDC 81/2008, a rule that governs the importation of products subject to ANVISA’s consent.

QR Group, a specialist in health regulation in Brazil, is prepared to help companies adapt to these changes, ensuring regulatory compliance in an agile and safe way.

Impacts of the Revision of RDC 81/2008 on the Importation of Health Products

RDC 81/2008 is one of the most comprehensive normative frameworks of sanitary regulation in Brazil, as it deals with different categories of products, import purposes, and types of importers. In addition, the rule interacts directly with customs regulations of the Federal Revenue Service, impacting import regimes and logistics processes.

Since 2013, ANVISA has signaled the need to revise this standard to modernize its requirements and harmonize them with technological advances and changes in global supply chains. The recently approved RAIR confirms this need and proposes the reformulation of RDC 81/2008, dividing it into a Collegiate Board Resolution (RDC) that brings general requirements and specific Normative Instructions for the import and export of different categories of products.

How QR Group Ensures Fast and Secure Compliance

With expertise in the regulatory sector, QR Group constantly monitors ANVISA’s regulatory updates to offer agile solutions to manufacturers and importers. Our team is ready to:

• Interpret and apply regulatory changes in the context of your business.
• Assist in the ANVISA petition and document adequacy.
• Reduce risks of rejections and delays in the import process.
• Ensure that your company is prepared for the new regulation before the changes take effect.

What to expect next?

With the approval of the RIA Report, the next step in the regulatory process includes the preparation of the regulatory drafts and the opening of public consultation. QR Group will continue to follow each step to keep our customers informed and prepared for this transition.

If your company imports products subject to ANVISA’s consent, it is essential to be aware of the changes in RDC 81/2008. Contact QR Group to ensure compliance and regulatory security!

Source: ANVISA