QR Group explains regulatory impacts and guides companies on how to maintain compliance safely

ANVISA has published a new technical statement on the regulatory framework for medical device components, bringing important clarifications for manufacturers, importers and distributors. The update reinforces the need to evaluate, on a case-by-case basis, the destination and risk of the components, in order to determine whether or not there will be a mandatory sanitary registration.

With a focus on uncomplicating the impacts of this new guideline, QR Group — a consulting firm specializing in health product regulation — explains how companies can adapt to the agency’s new positioning without compromising operational fluidity.

What changes with ANVISA’s new position?

According to the statement, components and parts of medical devices do not need sanitary registration when they are used exclusively in the manufacture of products already regularized in Brazil. However, the scenario changes if these items are imported for direct replacement or separate marketing.

In these cases, it is necessary to verify whether the component has a critical function in the functioning of the product or if it represents a health risk. If so, it must go through its own regularization process before being released for use or sale.

The measure aims to prevent uncontrolled items from entering the country, while maintaining flexibility for legitimate manufacturing operations.

Risks and challenges for importers and manufacturers

ANVISA’s new guidance directly impacts the logistics, regulatory, and commercial routines of companies in the sector. Among the main points of attention are:

• Careful evaluation of the destination and application of each component;

• Risks of cargo retention or fines due to incorrect interpretation of the rule;

• Differentiation between internal manufacturing use and direct distribution;

• Need for regulatory review for critical or field-replaceable parts.

Importing without proper technical alignment can generate financial losses, operational delays, and legal penalties.

How QR Group supports companies in the face of new demands

QR Group acts in a technical, agile and safe way to help its customers make assertive decisions in the face of regulatory changes like this. Among the services offered are:

• Technical and regulatory analysis of imported components;

• Formal opinions on mandatory registration;

• Support in ANVISA petitioning, when necessary;

• Technical consultations with the agency, with specialized monitoring.

With solid experience and a multidisciplinary team, QR Group ensures that import processes occur with predictability, minimizing risks and optimizing results.

Talk to QR Group

Does your company import medical device components?
Count on QR Group to ensure full compliance with ANVISA, with agility, security and specialized technical support.

Source: QR Group