Class I medical device registration with Brazil ANVISA refers to the process by which low-risk medical devices are officially approved for sale and use in Brazil. Class I devices are subject to a simplified regulatory pathway due to their minimal risk to patient health and safety.

Key Aspects of Class I Medical Device Registration with Brazil ANVISA:

1. Low-Risk Classification:

   • Class I devices are considered low-risk medical devices, meaning they generally do not pose significant harm to patients or users under normal conditions of use. Examples include basic medical instruments like bandages, surgical gloves, and non-invasive devices like stethoscopes or thermometers.
   • These devices are subject to less stringent regulatory scrutiny than higher-risk devices (Class II, III, or IV) and are typically subject to the Cadastro pathway (notification process).

2. Cadastro (Notification) Pathway:

   • Class I devices are registered through Cadastro, a simplified registration process that involves the notification of the device to ANVISA, rather than the more complex and detailed registration procedures required for higher-risk devices.
   • In this process, the Brazilian Registration Holder (BRH), which is a local company or representative, submits the required documentation to ANVISA to notify them of the device’s presence on the market.

3. Regulatory Compliance:

   • Even though the process is simpler, Class I devices still need to meet certain regulatory requirements. These include:
     • Compliance with RDC 185/2001, which outlines the criteria for device classification in Brazil.
     • Ensuring that the device meets labeling, safety, and manufacturing standards.
     • Providing necessary documentation, such as product descriptions, labeling in Portuguese, and basic risk management reports.

4. Application Requirements:

   • The BRH will submit technical documentation (including labeling and instructions for use in Portuguese, product descriptions, and manufacturing details) to ANVISA.
   • The device is reviewed for compliance with Brazil’s medical device regulations, including quality management standards (e.g., ISO 13485, if applicable).

5. Registration Number and Market Access:

   • Once the application is reviewed and approved by ANVISA, the device is granted a Cadastro registration number, which allows the device to be legally marketed and sold in Brazil.
   • Class I registration is typically valid for five years, after which it must be renewed.

6. Post-Market Obligations:

   • Even for Class I devices, manufacturers and their Brazilian representatives must adhere to post-market surveillance and vigilance obligations. This includes monitoring adverse events, handling complaints, and ensuring product recalls if necessary.

In Summary:

Class I medical device registration with ANVISA means that the device, being of low risk, can be marketed in Brazil after a simplified notification process. The device must comply with Brazil's regulatory requirements, such as having clear labeling in Portuguese, and must be submitted by a Brazilian Registration Holder (BRH). While the process is streamlined compared to higher-risk devices, it still requires thorough documentation and adherence to local regulations.