Single-use products have become increasingly popular thanks to a number of factors, including convenience, due to their practicality and ease of use on a daily basis, as well as hygiene, as they reduce the risk of contamination. Because of these characteristics, these products cover a wide range of items, from food packaging and personal hygiene products to medical supplies, which is the main subject of this blog.

Despite criticism of their environmental impact, the use of single-use products offers numerous benefits that contribute to the safety of patients and healthcare professionals. The use of disposable materials after each patient minimizes the risk of transmission of infectious diseases such as hepatitis, HIV and others. Single-use materials guarantee a high level of hygiene during medical procedures, reducing the microbial load and the risk of cross-contamination. By avoiding the reuse of contaminated instruments, both the patient and the healthcare professional are protected. Although the unit cost of a disposable material may be higher, in the long term, the use of these materials can generate savings by avoiding reuse costs, such as cleaning, sterilization and equipment maintenance.

The registration of single-use products with ANVISA aims to ensure that the products meet technical requirements such as safety for the patient and healthcare professional, efficacy and veracity in relation to the information provided by the manufacturer, quality in terms of their functions and conditions of use, as well as the legal requirements necessary for proper marketing.

Stages of the process and general requirements for registration

The registration process follows these steps:

1. Product classification: The first step is to classify the product according to its function and risk. This classification will determine the specific requirements for registration.
2. Documentation: The manufacturer must prepare complete and detailed product documentation, containing performance and safety test results; information on the manufacturing process; labeling and instructions for use; among others.
3. ANVISA analysis: ANVISA assesses the documentation and may request additional information or inspections at the factory.
4. Granting of Registration: If the documentation is complete and meets the requirements, ANVISA grants the registration, which is valid for a certain period.

In addition to these stages, there are general requirements for registration, such as the manufacturing company having a quality management system that meets the requirements of Good Manufacturing Practices (GMP).

The ANVISA registration process is complex and requires specific technical expertise that Stone Okamont possesses. For this reason, it is highly recommended to have the support of a specialized technical advisor to help prepare the documentation and monitor the process.