Class I Medical Device Registration with ANVISA (Brazil)

In Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) regulates the safety and efficacy of medical devices. The classification of medical devices in Brazil follows risk-based criteria, where Class I medical devices are considered low-risk products. These devices generally require fewer regulatory requirements compared to higher-risk categories (Classes II, III, or IV).

Class I Medical Device Characteristics

Class I devices typically:

• Are intended for low-risk uses
• Are non-invasive or minimally invasive
• Have a low potential for harm
• Are not intended to support or sustain life

Examples of Class I devices include basic products like:

• Bandages
• Thermometers
• Non-invasive diagnostic devices

How to Apply for Class I Medical Device Registration with ANVISA

The process of registering a Class I medical device with ANVISA is simpler than for higher-risk devices but still requires compliance with several regulatory steps.

Steps to Apply for Class I Medical Device Registration:

1. Confirm the Product Classification

   • Ensure the product is indeed classified as Class I under ANVISA’s regulations. This step is crucial because the classification dictates the level of regulatory scrutiny.
   • Refer to Resolution RDC 185/2001 for classification criteria, which is based on risk.

2. Prepare the Required Documentation

   • Product Information: This includes the product's description, intended use, and labeling.
   • Technical Documentation: Provide detailed technical specifications, materials used, design, and intended purpose.
   • Risk Management: A basic risk analysis based on international standards (e.g., ISO 14971) to demonstrate product safety.
   • Good Manufacturing Practices (GMP) Evidence: Proof of compliance with GMP, especially if the manufacturer is located outside Brazil. The product should be manufactured according to recognized standards.
   • Conformity with National or International Standards: If applicable, demonstrate conformity with ISO standards or other relevant regulations.

3. Designate a Local Representative

   • If the manufacturer is based outside of Brazil, a local representative must be designated. This representative will submit the application on behalf of the manufacturer and act as the point of contact with ANVISA.

4. Submit the Application through ANVISA’s e-PL System

   • The application must be submitted via the e-PL system, which is ANVISA’s electronic platform for submitting medical device registration applications.
   • The submitted application should include:
     • The technical file with the product documentation
     • Proof of local representation (if applicable)
     • Any other documentation required by ANVISA.

5. ANVISA Review

   • ANVISA will review the submitted documentation to ensure the product complies with regulatory requirements. Since Class I devices are lower-risk, this process typically takes less time than higher-risk devices.
   • If the submission is complete and satisfactory, ANVISA will approve the registration.

6. Receive the Registration Certificate

   • Upon approval, ANVISA will issue a registration certificate for the medical device, confirming that it can be marketed and sold in Brazil.
   • The registration is typically valid for five years and must be renewed periodically.

7. Post-Market Obligations

   • Even after registration, the manufacturer must comply with post-market surveillance obligations, including adverse event reporting and annual updates (if applicable).
   • Manufacturers must also be prepared for potential inspections by ANVISA to ensure compliance with manufacturing practices and safety standards.

Key Considerations for Class I Medical Device Registration

• Local Representation: For foreign manufacturers, a local representative is mandatory.
• Product Changes: Any changes to the product after registration (e.g., design changes, updates to the intended use) may require a new submission to ANVISA.
• Regulatory Fees: There may be administrative fees for registration, although they are generally lower for Class I devices.

Conclusion

Class I medical device registration with ANVISA in Brazil is a streamlined process, but it requires adherence to regulatory requirements, including providing technical and safety documentation, designating a local representative (for foreign manufacturers), and submitting the application via ANVISA’s e-PL system. Once approved, the device can be marketed in Brazil for five years, with periodic updates or renewals.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn