To apply for Class I medical device registration with Brazil's ANVISA (National Health Surveillance Agency), certain conditions and requirements must be met to ensure compliance with Brazilian regulations. Below is a detailed outline of the conditions that need to be satisfied:

Conditions to Be Met for Class I Medical Device Registration with ANVISA

1. Device Classification

• The device must be classified as Class I under ANVISA’s classification system. Class I devices are considered low-risk and are subject to less stringent regulatory requirements compared to higher-risk devices (Classes II, III, and IV).
• Typical examples of Class I devices include basic surgical instruments, bandages, non-invasive diagnostic tools, and other low-risk medical products.

Note: You must verify that the device qualifies as Class I by reviewing ANVISA's classification criteria or by consulting with a local expert or the Brazilian Registration Holder (BRH).

2. Brazilian Registration Holder (BRH)

• Foreign manufacturers must appoint a Brazilian Registration Holder (BRH). The BRH is a local representative or company that will submit the registration application to ANVISA on behalf of the foreign manufacturer.
• The BRH must be registered with ANVISA and have the legal authority to handle regulatory matters concerning medical devices in Brazil.

Important Note: The BRH is also responsible for managing communications with ANVISA and ensuring compliance with Brazilian regulations, so it is crucial to select a reliable BRH.

3. Compliance with Brazilian Regulatory Requirements

• The device must comply with Brazilian health regulations set out by ANVISA and the Brazilian Health Surveillance Code (RDC).
• The manufacturer must demonstrate that the device meets the necessary safety and performance standards as specified by ANVISA.
• In some cases, the device may need to comply with international standards such as ISO 13485 for Quality Management Systems (QMS), although this is more often required for higher-risk devices.

4. Submission of Required Documentation

• Device Description: A clear and detailed description of the medical device, including its intended use, components, and operation.
• Instructions for Use (IFU): The IFU must be in Portuguese and contain all necessary safety and usage instructions, including warnings, contraindications, and indications.
• Labeling: The device’s label must meet ANVISA’s requirements, including product name, manufacturer details, model number, batch number (if applicable), expiration date, and any relevant safety symbols. All labeling must be in Portuguese.
• Quality Management System (QMS): Although not always mandatory for Class I devices, ISO 13485 or equivalent certification for a Quality Management System is often required.
• Product Testing or Safety Documentation: Safety and performance data may be required, depending on the device’s nature. This could include:
  • Biocompatibility tests (for devices that come into contact with the body)
  • Electrical and mechanical safety testing (for electronic devices)
  • Sterilization validation (if the device is sterile)
• Authorization Letter for BRH: An official authorization letter from the manufacturer appointing the BRH to act on their behalf during the registration process.
• Declaration of Conformity: A declaration confirming that the device complies with Brazilian regulatory standards and relevant international standards.
• Sterilization Documentation (if applicable): If the device is sterile, proof of sterilization process and validation results must be provided.

5. Device Not Involved in High-Risk Procedures

• Class I devices are low-risk and cannot be intended for high-risk procedures (e.g., implantable devices or those that involve direct life-support functions).
• If a device is intended for higher-risk medical applications, it may need to be reclassified to a higher class (e.g., Class II, III, or IV), which requires more stringent regulatory procedures.

6. Payment of Fees

• The registration application must be accompanied by the applicable registration fee, which can be paid through ANVISA's online payment system. The fees are generally lower for Class I devices compared to higher-risk devices.

Note: The fee is usually paid after the application is submitted and the BRH is responsible for handling the payment.

7. Compliance with Post-Market Surveillance Requirements

• After approval, the manufacturer must comply with Brazil's post-market surveillance requirements. This includes:
  • Reporting any adverse events or device malfunctions.
  • Monitoring the safety and effectiveness of the device in the Brazilian market.
• The device must be traceable, and the manufacturer must maintain records of any product complaints or safety incidents.

8. Language Requirements

• All documents submitted to ANVISA, including the instructions for use, labeling, and technical descriptions, must be in Portuguese. This is mandatory for all medical device registrations in Brazil.
• Accurate and clear translations must be provided for foreign manufacturers, especially for product labeling and instructions.

Summary of Conditions for Class I Medical Device Registration

1. Class I Classification: Ensure the device qualifies as a Class I medical device.
2. Appoint a Brazilian Registration Holder (BRH): Foreign manufacturers must appoint a BRH.
3. Compliance with ANVISA Regulations: Meet Brazilian regulatory standards, including safety, performance, and labeling requirements.
4. Submission of Required Documents: Prepare and submit all required documentation, including device description, IFU, labeling, and proof of quality systems.
5. Non-High-Risk Device: The device must be low-risk and not intended for high-risk procedures.
6. Payment of Registration Fee: Pay the applicable registration fee through ANVISA’s online system.
7. Post-Market Surveillance: Adhere to post-market monitoring and reporting requirements.
8. Language Compliance: All documents must be in Portuguese.

By ensuring all these conditions are met and submitting the correct documentation through the designated process, you can apply for and successfully obtain Class I medical device registration with ANVISA in Brazil.

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