The cost and timeline for registering a Class I medical device with ANVISA in Brazil are generally more streamlined compared to higher-risk devices, but they still depend on various factors, such as the complexity of the application and whether the manufacturer is domestic or foreign.

1. Cost of Class I Medical Device Registration

The costs for registering a Class I medical device with ANVISA are relatively modest compared to higher-risk devices. However, they still include administrative fees for processing and registration. The main cost components are:

• ANVISA Registration Fees: These are the administrative fees for the registration process. For Class I devices, the fees are typically lower than for Class II, III, or IV devices.

  • The exact fee depends on the device type and ANVISA’s current fee structure. ANVISA regularly updates its fees.
  • As of recent information, the registration fee for Class I devices typically ranges between BRL 1,500 to BRL 3,000 (Brazilian Real), though you should consult ANVISA or a regulatory consultant for up-to-date details.

• Local Representative Fees (if applicable): If the manufacturer is located outside of Brazil, a local representative is required, and they typically charge a fee for handling the registration process. This fee can vary widely, depending on the service provider.

• Additional Costs: If you need assistance with the technical documentation, translations, or quality management system (GMP) certifications, additional costs may apply. For example, translations of technical documents into Portuguese, ISO certifications, or legal advice could add to the overall cost.

2. Timeline for Class I Medical Device Registration

The timeline for registering a Class I medical device with ANVISA is typically shorter than for higher-risk devices, but the exact duration can depend on the completeness of the application and any potential delays in the review process.

• Average Timeline: For a Class I device, the registration process typically takes around 30 to 90 days (about 1 to 3 months). This includes the time for ANVISA to review the application and issue the registration certificate if the application is complete and compliant.

  • Initial Review and Submission: The process starts with the submission of the application via ANVISA's e-PL system. The submission itself can take anywhere from a few days to a week, depending on the preparedness of the documentation.

  • ANVISA Review Process: Once submitted, ANVISA reviews the application. Since Class I devices are lower-risk, the review process is usually quicker, typically within 30 to 60 days.

  • Possible Delays: Delays can occur if the application is incomplete or if ANVISA requests additional information or documentation. If the device requires further clarification or testing data, the timeline could extend.

Summary of Cost and Timeline for Class I Medical Device Registration

• Cost:
  • ANVISA registration fees: BRL 1,500 to BRL 3,000 (approximately).
  • Local representative fees (if applicable) and any additional costs for services like translations, GMP certification, or regulatory consulting.
• Timeline:
  • The registration process typically takes around 30 to 90 days (1 to 3 months), assuming all documentation is complete and there are no significant delays.

These figures are estimates, and actual costs and timelines may vary depending on the specific device, the complexity of the submission, and the regulatory support needed. For the most accurate and up-to-date information, it is advisable to check directly with ANVISA or a regulatory consultant in Brazil.