ANVISA regulates the use of Covid-19 self-tests

On January 28, 2022, the National Health Regulatory Agency (ANVISA) published Rule No. 595 (“RDC 595/2022”), This rule establishes the requirements and procedures for applying for registration, distribution, sale and use of COVID-19 self-tests (also referred to as home tests or over-the-counter/OTC tests). The new rule entered into force on the date of its publication.

Below is a brief summary of the main aspects of RDC 595/2022:

• Points of Sale: Only pharmacies and healthcare establishments licensed to sell medical devices can sell self-tests.

However, offering self-tests on the internet and on websites that do not belong to pharmacies or healthcare establishments authorized and licensed by the respective health authorities is banned.

• Distribution through the Public Health System: Self-test distribution is allowed in order to meet public policies of the Ministry of Health or of State, Municipal, and Federal District Health Departments.

• Registration: No self-test can be commercialized immediately in the country. Legally qualified companies that wish to put these devices on sale will have to register the product with ANVISA. The new Rule establishes all the criteria for the registration application.

• Priority: Applications within the scope of self-tests will have priority in the analysis phase for the purposes of granting registration, for as long as the declaration of Public Health Emergency remains in place.

• Registration holder’s responsibilities: Self-tests are monitored post-commercialization through Vigipós, the System for Notification and Investigation in Sanitary Oversight. The registration holder must be responsible for all post-commercialization oversight actions of the product, throughout its life cycle. This includes establishing mechanisms to monitor and notify of technical complaints and adverse events, recall the product when determined by ANVISA or whenever there is sufficient evidence that the device does not meet quality, safety and performance requirements, and notification of field actions arising from adverse events associated with the product.

• Retail sector’s responsibilities: (i) notify of adverse events and technical complaints in the Sanitary Oversight Notification System, Notivisa; and (ii) provide users with information about how to carry out the tests at home.

ANVISA also made available “Frequently Asked Questions about the COVID-19 Self-Test” – (Portuguese version only).

Demarest’s Life Sciences Team continues to monitor activities in the sector and is available should you need any further clarification on this matter.