Medical Product Traceability at ANVISA

Medical Product Traceability at ANVISA

The traceability of medical products plays a fundamental role in ensuring patient safety and healthcare service quality. In Brazil, the National Health Surveillance Agency (ANVISA) plays a crucial role in regulating and overseeing this aspect, establishing norms and guidelines to ensure effective traceability of medical products. In this blog, we will explore the importance of medical product traceability at ANVISA and how this process contributes to safety and quality in the healthcare sector.


What you will find in this blog:

Definition of Traceability

First and foremost, it is important to understand what traceability means in the context of medical products. Traceability refers to the ability to trace a medical product throughout the entire supply chain, from its production to its use by the patient. This involves documenting and monitoring all stages of the process, including manufacturing, distribution, storage, and utilization.

Which Products Require Traceability by ANVISA?

The National Health Surveillance Agency (ANVISA) establishes traceability requirements for various types of products in the healthcare field, including:

Medicines: All medicines marketed in Brazil must have traceability, ranging from generic to brand-name drugs. This allows for monitoring the entire life cycle of the medicine, from manufacturing to patient use.

Medical Devices: Medical equipment, implantable devices, surgical instruments, among others, also require traceability. This is essential to ensure the safety and effectiveness of these products, as well as to identify and address any problems that may arise.

Active Pharmaceutical Ingredients (APIs): Raw materials used in drug manufacturing must also be traceable to ensure the quality and safety of the final products.

In summary, a wide range of products in the healthcare field must meet traceability requirements established by ANVISA, aiming to ensure patient safety and the quality of products marketed in Brazil.

What are ANVISA Regulations on Traceability?

ANVISA establishes specific regulations related to the traceability of medical products in Brazil. These regulations aim to ensure that medical products marketed in the country meet the highest standards of safety and quality. ANVISA sets requirements for the traceability control of medical products, defining the responsibilities of manufacturers, importers, distributors, and healthcare service providers in this process.

The benefits of traceability include:

Product safety: Allows for the quick identification and location of defective or contaminated products, reducing the risk for consumers.

Assured quality: Helps maintain consistent quality standards throughout the supply chain, ensuring that products meet specifications and regulations.

Quick response to issues: Enables a rapid response to safety or quality issues, such as product recalls, protecting the company's reputation and preventing harm to consumers' health.

Regulatory compliance: Assists companies in complying with government regulations and product safety requirements, avoiding fines and penalties.

Supply chain transparency: Provides consumers with transparency about the origin and history of products, building trust and brand loyalty.

Process improvement: Provides valuable data for analysis and continuous improvement of production and distribution processes.

Still have questions?

Count on Stone Okamont's experience to ensure that this process promotes the safety and quality of your product traceability. We are prepared to be your trusted partner on the journey toward compliance and excellence.

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