Covid-19 self-tests approved for sale and use in Brazil
Anvisa to prioritize registration requests for self-testing devices
On January 28, 2022, the Brazilian Health Regulatory Agency (Anvisa) approved and published Anvisa Resolution No. 595/2022, establishing requirements and procedures for registering, distributing, marketing and using self-tests for detecting Covid-19 antigens. The new resolution is already in effect.
This development was motivated by the latest wave of infections stemming from the highly contagious Covid-19 Omicron variant, which has resulted in a significant increase in demand for testing. The approval of self-testing as part of Brazil’s National Expanded Testing Plan for Covid-19 follows the movement of health authorities in other countries, such as the Center for Disease Control (CDC) in the United States and the European Centre for Disease Prevention and Control (ECDC) within the European Union.
Public policies required for self-testing
Defined as products for monitoring symptoms or detecting specific conditions, self-tests may be conducted by members of the general public, healthcare professionals or clinical laboratories with a view to assisting the patient. However, as per Anvisa Resolution No. 36/2015 (which covers risk classification, registration, labeling, and instructions for using in vitro diagnostic products), self-tests are not to be used for determining conclusive diagnoses in Brazil.
As a general rule, the 2015 resolution prohibits self-testing in order to verify the presence of or exposure to pathogenic organisms or transmissible agents – including those that cause infectious diseases that require notification, such as Covid-19. Nonetheless, this prohibition can be suspended when the Ministry of Health formally implements public policies that include the use of self-testing devices as part of a strategic plan to fight and control diseases.
For example, self-testing for Human Immunodeficiency Virus (HIV) has been permitted in Brazil since 2015, as a result of Anvisa Resolution No. 52/2015, which established registration and sale requerements, and the inclusion of self-testing as part of the AIDS Combat Policy.
Self-testing regulation process
On January 13, 2022, Brazil’s Ministry of Health issued a technical note requesting that Anvisa evaluate whether self-testing should be used as an additional strategy to prevent and limit Covid-19 transmission, along with vaccination, the use of masks and social distancing. However, Anvisa´s view was that there was insufficient information in the technical note to formalize a public policy on the issue.
The Ministry of Health thus complemented the technical note with a letter on January 25, informing Anvisa that it sought to include self-testing devices in public policy by adding a specific chapter to the National Plan to Expand Testing for Covid-19 (PNE-Teste).
According to Anvisa’s new resolution, the self-test for detecting the SARS-CoV-2 antigen must be classified as a Class III device. It must also employ the qualitative immunochromatographic assay methodology, which includes steps for collecting samples and visually evaluating the results — software or products combined with other parameters are excluded.
The regulation states that the instructions for self-tests must be clear, containing pictures to assist patients (i.e., members of the general public without formal medical knowledge) in understanding the procedure for collecting biological material and interpreting the results. Moreover, pre-test and post-test information must be included, including warnings, guidelines, precautions and limitations, as well as disposal guidelines for used kits.
The following requirements must be met for registering, distributing, and selling self-testing devices:
- The National Institute for Quality Control in Health (INCQS) must have analyzed the product, verifying its performance with respect to sensitivity (greater than or equal to 80%) and specificity (greater than or equal to 97%);
- The product’s external labeling must include all of the test kit’s necessary components, as well as the device’s expiration date – the latter must be clearly marked on each of the kit’s components in order to prevent use of the device after expiration;
- The product registration holder must provide customer service support to users, with direct access to trained personnel that can attend customers’ demands, assist in interpreting results, and provide guidance on using the product and how to proceed after obtaining results;
- The product’s instructions must indicate contact details for the company’s call center and the Ministry of Health’s Dial Health Service, as established in the PNE-Teste.
The self-testing device will be subject to product quality monitoring once it is on the market. At the same time, the registration holder will be responsible for:
- Establishing mechanisms to monitor technical complaints and adverse events;
- Notifying the Health Surveillance Notification System (Notivisa) of adverse events and technical complaints concerning medical devices (this also applies to retailers);
- Providing clear instructions about reporting channels for technical complaints and adverse events associated with the devices, following techno-vigilance guidelines;
- Recalling the product if requested to do so by Anvisa, or whenever there is sufficient evidence that the kit does not meet essential quality, safety and performance requirements; and
- Reporting field actions resulting from adverse events associated with self-tests.
Anvisa has also emphasized that it is prohibited to sell self-tests on websites that do not belong to pharmacies or licensed health establishments.
For further information about self-testing for Covid-19, please contact Mattos Filho’s Life Sciences and Healthcare practice.
*With the collaboration of Camila Miranda Amaral.