To apply for Class I medical device registration with ANVISA in Brazil, you must meet certain conditions as outlined in Brazilian regulatory requirements. Class I devices are considered low-risk, non-invasive devices that have basic safety and performance standards. Below are the key conditions that must be met in order to apply for Class I medical device registration:

1. Classification of the Device

• The device must be classified as Class I according to ANVISA’s RDC 185/2001. Class I devices are low-risk, non-invasive products such as bandages, thermometers, or non-invasive diagnostic devices.
• You need to confirm that the device meets the criteria for Class I, as higher-risk devices (Class II and above) have stricter regulatory requirements.
• Class I devices do not require clinical trial data, but you must provide sufficient documentation proving safety and effectiveness based on design and performance standards.

2. Compliance with Brazilian Regulations

• Product Compliance: The device must comply with Brazilian health regulations and ANVISA standards, which may include product-specific standards related to safety, labeling, and risk management.
• Risk Management: Even for low-risk devices, you are required to demonstrate that the risks associated with the device have been assessed and are appropriately managed. This typically involves a simplified risk analysis (based on ISO 14971 or similar standards) to show how potential risks are mitigated.

3. Manufacturer’s and Local Representative’s Eligibility

• Manufacturer: The manufacturer must either be based in Brazil or have a local representative in Brazil if the manufacturer is located abroad.
  • If the manufacturer is a foreign entity, a Brazilian local representative is required. This representative will be the official point of contact with ANVISA and will handle all communications related to the registration process.
  • The local representative must be authorized by the manufacturer via a power of attorney.

4. Good Manufacturing Practices (GMP)

• If the device is manufactured outside Brazil, you must show compliance with Good Manufacturing Practices (GMP), which is generally verified through ISO 13485 certification or equivalent.
• For foreign manufacturers, ANVISA requires documentation proving that the device is manufactured according to quality management standards that ensure safety and effectiveness. This includes compliance with GMP for all stages of production (design, manufacturing, and testing).

5. Proper Labeling and Instructions for Use (IFU)

• Labeling must meet the standards defined by ANVISA and must include, at a minimum:
  • The name and address of the manufacturer or local representative.
  • Description of the device, including the intended use.
  • The expiration date (if applicable).
  • Batch or lot numbers (for traceability).
  • Warnings, precautions, and contraindications (if applicable).
• The Instructions for Use (IFU) must be written in Portuguese and contain detailed information on how to use the device safely and effectively.

6. Conformity with International Standards

• While Class I devices typically do not need extensive clinical data, they must still meet relevant international standards (e.g., ISO 13485, ISO 14971).
• Compliance with ISO standards and other recognized safety standards can help facilitate the registration process, especially for foreign manufacturers.

7. Application Documentation

• You must prepare and submit complete and accurate documentation through the e-PL system, ANVISA’s online portal. Required documents include:
  • Product Description (name, intended use, design, materials).
  • Technical documentation (performance data, risk management).
  • Good Manufacturing Practices (GMP) certification (if applicable).
  • Local representative documentation (for foreign manufacturers).
  • Proof of conformity (if applicable, such as international certifications).

8. Payment of Registration Fee

• A registration fee must be paid to process the Class I medical device application. The fee is generally BRL 1,500 to BRL 3,000, depending on the device type and regulatory fee schedule.

9. Post-Market Surveillance Commitment

• After the device is registered, the manufacturer or local representative must ensure compliance with post-market surveillance obligations, which may include:
  • Reporting adverse events or product defects to ANVISA.
  • Ensuring that the device remains compliant with regulatory standards throughout its lifecycle.
  • Conducting any necessary corrective actions or recalls if safety issues arise.

Summary of Conditions for Applying for Class I Medical Device Registration with ANVISA:

1. Device Classification: Must be a low-risk, non-invasive device (Class I).
2. Compliance with Regulations: The device must meet ANVISA’s regulatory standards for safety and performance.
3. Manufacturer and Local Representative: A local representative in Brazil is required for foreign manufacturers.
4. Good Manufacturing Practices (GMP): For foreign manufacturers, GMP compliance must be demonstrated.
5. Labeling and Instructions: Labels and IFU must be compliant with ANVISA’s requirements (in Portuguese).
6. Conformity with Standards: Compliance with international standards such as ISO 13485, ISO 14971, etc.
7. Application Documentation: Complete and accurate documentation must be submitted through the e-PL system.
8. Registration Fee: Payment of the applicable registration fee.
9. Post-Market Surveillance: Commitment to ongoing monitoring of the device’s safety and performance in the market.

By ensuring that these conditions are met, you can proceed with the registration application process for your Class I medical device with ANVISA in Brazil.

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