The cost and time required for obtaining Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) are generally lower compared to higher-risk classes. However, the exact duration and fees can vary depending on several factors such as the type of device, the completeness of the application, and the efficiency of the process.

Cost of Class I Medical Device Registration with ANVISA

• Registration Fees: The fees for Class I medical device registration are relatively low compared to higher-risk devices. As of recent guidelines, the fee for Class I devices typically ranges between BRL 1,000 to BRL 2,000 (Brazilian Reais), depending on the applicant's company size and the type of device.
• Additional Costs: There may be additional costs associated with:
  • Brazilian Registration Holder (BRH): If you're a foreign manufacturer, you will need to appoint a local representative (BRH), and their fees will vary depending on the services provided.
  • Translation Costs: Documents (e.g., instructions for use, labeling, and technical file) must be translated into Portuguese, and this may involve additional costs.
  • Quality Management System (QMS): If your company needs to obtain or maintain ISO 13485 certification, this could also add to the costs.

Time Required for Class I Medical Device Registration

• Review Time: For Class I devices, the review process by ANVISA is typically faster than for higher-risk classes. On average, the time to obtain approval is around 30 to 60 days (1 to 2 months), provided that the submission is complete and compliant.
• Factors Affecting Timeline:
  • Completeness of the Application: Delays may occur if the submission is incomplete or if additional information is requested by ANVISA.
  • ANVISA Workload: During peak times or if ANVISA is handling a large volume of applications, the review time could be longer.
  • Quality of Local Representation: A well-prepared Brazilian Registration Holder (BRH) can help expedite the process by ensuring all necessary documents are in order and submitted correctly.

Summary:

• Cost: BRL 1,000 to BRL 2,000 for registration, with additional costs for a local representative (BRH) and document translation.
• Time: Typically 30 to 60 days for approval, depending on the completeness of the application and ANVISA’s workload.

By carefully preparing the application and ensuring that all documentation is complete and accurate, you can minimize the time and costs associated with obtaining Class I medical device registration in Brazil.

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