For Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil, manufacturers must adhere to several key standards and regulations that govern the registration process and ensure the safety, efficacy, and quality of medical devices. Here are the main standards and guidelines relevant to the registration of Class II medical devices:

1. ANVISA Regulations

• RDC No. 16/2013: This resolution outlines the registration and regulation process for medical devices in Brazil. It provides guidelines on classification, documentation requirements, and registration procedures.
• RDC No. 36/2015: This resolution establishes general requirements for good manufacturing practices (GMP) for medical devices, ensuring that manufacturers maintain high-quality production standards.

2. ISO Standards

• ISO 13485: This international standard specifies requirements for a quality management system (QMS) that demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Compliance with ISO 13485 is often required for manufacturers seeking registration.
• ISO 14971: This standard focuses on the application of risk management to medical devices. It provides a framework for identifying, evaluating, and controlling risks throughout the lifecycle of a medical device.

3. Technical Standards

• IEC 60601 Series: If applicable, compliance with this series of standards on the safety and performance of electrical medical equipment may be necessary. These standards cover general safety, performance, and usability requirements.
• ISO 10993: This series of standards pertains to the biological evaluation of medical devices, providing guidelines for assessing the biocompatibility of materials used in medical devices.

4. Labeling and Instructions for Use

• ANVISA requires that all labeling and instructions for use comply with Brazilian regulations. This includes ensuring that information is presented clearly in Portuguese and contains all necessary warnings, contraindications, and usage instructions.

5. Post-Market Surveillance

• Manufacturers are expected to comply with post-market surveillance requirements to monitor the performance and safety of the device once it is on the market. This may involve adhering to guidelines outlined in ANVISA’s regulations and relevant ISO standards.

Summary

In summary, the standards for Class II medical device registration with ANVISA include adherence to specific ANVISA regulations (such as RDC No. 16/2013 and RDC No. 36/2015), compliance with ISO standards (ISO 13485, ISO 14971), and technical standards like IEC 60601 and ISO 10993 as applicable. Manufacturers must also ensure proper labeling and instructions for use, along with a commitment to post-market surveillance. By following these standards, manufacturers can help ensure that their medical devices meet regulatory requirements and are safe and effective for users. If you have any further questions or need more specific information, feel free to ask!

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