Brazil Emergency Use Pathways for Medical Devices and IVDs

Medical devices and IVDs are regulated by the National Health Surveillance Agency (ANVISA) in Brazil. The standard process includes registration/notification for all device classes and generally takes several months to complete.

In response to the COVID-19 pandemic, ANVISA has made special allowances for products used to combat the pandemic, included under the additional regulations RDC 346/2020, RDC 348/2020, RDC 349/2020, and RDC 483/2021 for devices related to COVID-19 or SARS-CoV-2. Registration via the special route must follow RDC 03/2010.  

Regulations, Guidance, and Resources

The special access routes are based on, and described further in, the following legislation:

  • RDC 03/2010: describes the rules for registration evaluation of medical devices in emergency routes.
  • RDC 346/2020: defines the temporary rules for Brazil Good Manufacturing Practice (B-GMP) in response to the COVID-19 outbreak.
  • RDC 348/2020: defines the criteria for registration of IVDs and other products, such as pharmaceuticals, in response to COVID-19.
  • RDC 349/2020: the temporary criteria and procedures for regularization of personal protective equipment (PPE), ventilators, and other medical devices identified as strategic by ANVISA due to the public health crisis.
  • RDC 356/2020: rules for manufacture, import, and acquisition of medical devices considered high-priority due to COVID-19.
  • RDC 379/2020: amends RDC 356/2020 with special provisions for COVID-19 related devices.
  • RDC 378/2020: import, sale, and donation of used equipment that is indispensable in intensive care units.
  • RDC 386/2020: manufacturing, commercialization, and donation of Artificial Manual Breathing Unit (Ambu) devices.
  • RDC 377/2020: describes the COVID-19 rapid test registrations in Brazil.
  • RDC 483/2021: list of devices exempt from registration due to COVID-19 when imported by health services and health public or private entities.
  • RDC 36/2015: regulation of IVD registration (Class III and IV) in Brazil.
  • RDC 40/2015: regulation of medical device registration (Class I and II) in Brazil.

Some English versions (not official government translations) are available at the Emergo by UL website.

Device types and eligibility criteria

Due to the international COVID-19 crisis, the devices listed on the WHO list are exempt from registration requirements, and importation is allowed for health services and health public or private entities. The importer must:

  • meet the regulatory rules to market the devices,   
  • maintain traceability records,
  • have in place post-market procedures,
  • provide labels and IFUs in Portuguese, and
  • comply with RDC 483/2021 and other regulations.

Stay informed about special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. The situation is changing daily, and we encourage you to create a free RAMS account, where you can access real-time updates on COVID-19 regulatory developments from our international research team.

 

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Allowances, requirements, and limitations

The following describes requirements for the emergency route. 

Medical devices:

  • All registrations (Class III and IV) approved by RDC 349/2020 are valid for 1 year and extended another year according to RDC 483/2021 (total of 2 years). During this period, a normal registration must be initiated in order to maintain the product on the market after the 2 years are up.
  • All notifications (Class I and II) are valid for 1 year and extended to another year according to RDC 483/2021, and renewal will not be allowed. After this year, a new notification must be submitted in order to keep the products on the market.

IVDs:

  • IVDs that detect COVID-19 need to follow RDC 36/2015. If performance studies are not available, justification must be provided that allows the evaluation of the reliability of results and effectiveness of the product.
  • If stability data is available for similar products, and all other criteria are met according to RDC 36/2015, the shelf-life of the product will be 6 months (except in situations where comparative studies indicate a shorter period). A shelf-life longer than 6 months will be allowed when supported by real-time data.
  • The registrations (Class III and IV) approved by RDC 348/2020 are valid for 1 year. During this period, an application must be submitted through the normal route to maintain the products on the market.
  • Labels must include “Aprovado para uso Emergencial” (Approved for emergency use).
  • ANVISA RDC 377/2020 allows COVID-19 rapid tests (immunochromatographic assays) to be sold to drugstores. The tests included in scope are to evaluate the presence of coronavirus antibodies or antigens, without the purpose of confirmatory diagnosis, and must be registered with ANVISA. The test must be performed by a pharmacist. All product complaints must be notified to ANVISA within 5 days.
  • The importer must send at least 100 units of diagnostic kits of each batch, within a maximum period of 5 days starting from the date of customs clearance, for analysis by the Institute National Quality Control – INCQS.
  • For all IVDs that detect COVID-19 that are not registered with ANVISA, the importer (healthcare institution for an example) must prove and ensure the sensitivity and specificity of the IVD.

Updated on 29 March 2021.

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