To apply for Class I medical device registration with ANVISA (Brazil's National Health Surveillance Agency), you'll need to follow these general steps:

1. Confirm Product Classification

• Verify that the device is classified as a Class I medical device according to ANVISA’s classification rules. Class I devices are typically low-risk products with minimal regulatory requirements.

2. Prepare Documentation

• Technical Documentation: Include detailed information about the product, such as:
  • Product description
  • Intended use
  • Labeling (including instructions for use, warnings, etc.)
  • Risk analysis (according to ISO 14971)
• Manufacturer Information: Provide details about the manufacturer, including the site inspection or certificate if the manufacturer is based outside Brazil.
• Good Manufacturing Practices (GMP): Evidence of compliance with Brazilian or international GMP standards, if applicable.
• Conformity Evidence: Provide evidence that the device complies with applicable regulations or standards (e.g., ISO standards).

3. Establish a Local Representative

• If the manufacturer is located outside Brazil, a local representative in Brazil is required. This representative will be responsible for submitting and managing the registration process on your behalf.

4. Submit Application

• Submit your registration application through ANVISA’s electronic system (e-PL).
• The application should include the following:
  • Technical file
  • Proof of local representation (if applicable)
  • Any other relevant documentation requested by ANVISA.

5. Review Process

• ANVISA will review the documentation submitted. If the product is considered a Class I device and meets all regulatory requirements, the registration process will be relatively quick (usually within a few weeks).

6. Certification

• If your application is approved, ANVISA will issue a registration certificate for the Class I medical device. This certificate is valid for five years.

7. Post-Market Surveillance

• Once the device is registered, ensure compliance with ANVISA’s post-market surveillance requirements, including adverse event reporting and periodic renewals or updates to the registration.

It’s important to be aware that while the process for Class I devices is less stringent than for higher-risk devices, ANVISA still requires adequate documentation and may request further information or clarification during the review process.

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