The time to obtain Class I medical device registration with ANVISA in Brazil typically takes around 1 to 3 months. However, the specific timeline can vary based on several factors, including the completeness of your application and the workload of ANVISA.

Breakdown of the Timeline:

1. Application Submission (1-2 weeks):

   • Once you submit the required documentation through the e-PL (Electronic Process) system, it usually takes around 1 to 2 weeks for ANVISA to acknowledge receipt of your application.
   • The application must be complete and include all necessary documents, such as the product technical file, labeling, and evidence of compliance with quality standards (e.g., ISO 13485).

2. ANVISA Review (4-8 weeks):

   • The document review process by ANVISA typically takes 4 to 8 weeks. ANVISA will assess the submitted documents to ensure that the device complies with Brazil’s regulatory requirements, such as safety, efficacy, and quality standards.
   • Since Class I devices are low-risk, this phase is generally quicker than for higher-risk devices (Class II or III).

3. Request for Additional Information (if applicable) (1-2 weeks):

   • If ANVISA requests further information or clarification about the device, the timeline will be extended. This may involve submitting additional documentation or correcting any issues identified during the review.
   • The time required to respond to any such requests depends on how quickly you can provide the necessary information.

4. Approval and Certificate Issuance (1-2 weeks):

   • After ANVISA completes the review and no issues are found, they will issue a Registration Certificate (Cadastro). This step usually takes another 1 to 2 weeks to finalize.
   • Once the certificate is issued, the device is authorized to be marketed and distributed in Brazil.

Factors that Can Affect the Timeline:

• Completeness and Accuracy of Documentation: If the initial submission is thorough and correct, it will speed up the process. Missing or incomplete information can delay approval.
• Requests for Additional Information: If ANVISA requests clarification or further documents, this will extend the review time.
• ANVISA's Workload: The processing time can vary depending on ANVISA's workload. If they are handling a high volume of applications, processing times may take longer.

Average Time:

• 1 to 2 months for the approval of Class I medical device registration if everything is in order and there are no issues.
• 2 to 3 months if there are any complications or if additional information is required.

In conclusion, you can generally expect the process for registering a Class I medical device with ANVISA to take between 1 to 3 months, assuming all documents are submitted correctly and promptly.