Yes, ANVISA has specific labeling and packaging requirements for medical devices in Brazil. These requirements are designed to ensure the safety, effectiveness, and proper use of medical devices, as well as to provide adequate information to healthcare professionals and patients. Some key aspects of ANVISA's labeling and packaging requirements for medical devices include:
1. Labeling Content: The labeling of medical devices should include essential information such as the device's identification (name, model, and serial number), intended use, contraindications, warnings, precautions, instructions for use, storage conditions, and the name and address of the manufacturer or authorized representative.
2. Language: The labeling should be in Portuguese or bilingual (Portuguese and another language commonly used in Brazil), depending on the intended user and the device's classification.
3. Symbols and Graphical Elements: The use of symbols and graphical elements should comply with ANVISA's requirements, including standardized symbols for functions such as "On/Off," "Do not reuse," and "Sterilized using irradiation."
4. Packaging: The packaging of medical devices should be designed to protect the device during transportation and storage, maintain its sterility (if applicable), and provide clear information about the contents. Packaging materials should be compatible with the device and its intended use.
5. Unique Device Identification (UDI): Certain medical devices are required to bear a Unique Device Identification (UDI) code, which allows for the identification and traceability of the device throughout its lifecycle. The UDI should be included on the device label and, if applicable, on the packaging.
6. Compliance with International Standards: ANVISA may require compliance with specific international standards for labeling and packaging, such as ISO 15223-1:2021 for symbols and ISO 13485 for quality management systems related to medical devices.
Compliance with these requirements is essential for obtaining and maintaining the registration of medical devices in Brazil.
