On May 10, 2023, the Collegiate Board of Commissioners of the National Health Surveillance Agency (ANVISA) published Resolution No. 786/2023, fully revoking Resolution No. 302/2005 and updating the technical requirements for operation of entities that perform laboratory tests in Brazil.

The Resolution is the result of public consultations, public hearings, technical meetings, direct consultations, and sectoral dialogues that have been held since 2017, considering changes in social behavior and health access dynamics, the development of new technologies, and the need to expand access to diagnostics.

Among other points, the Resolution includes pharmacies and drugstores as healthcare service units, in line with Law No. 13,021/2014, recognizing the importance of their capillarity in providing access to healthcare, verified especially during the Covid-19 pandemic in Brazil.

The Resolution includes an updated categorization of healthcare services that perform activities related to clinical analysis, as follows:

·      Type I service: pharmacies and isolated clinics – collections and laboratory tests on a screening basis, usually from primary biological material, exclusively by a legally licensed professional, provided that all stages of the examination must be performed after the collection and at the same location.

·      Type II service: collection stations – same characteristics as Type I service, storage of biological material in the pre-analytical scope and certain in-person tests.

·      Type III service: clinical laboratories and pathological anatomy laboratories – complex analysis, storage of biological material, and other clinical analysis.

In addition, the Resolution innovates in the following points:

(i) Definition of criteria and rules for sending biological material to support laboratories, sending biological material for analysis by a clinical laboratory located in foreign territory, operation of distribution centers for biological materials, traceability and reliability of tests and the link between the collection station and the laboratory;

(ii) Regulation of methodologies developed by the type III service providers (clinical laboratories);

(iii) Inclusion of anatomopathological laboratories and limitation of the scope of the norm to laboratory test services in biological material of human origin;

(iv) Authorization for the Ministry of Health and state and municipal health departments to define other environments for performing clinical analysis, observing the applicable specificities to the Brazilian Unified Health System; and

(v) Obligation of the applicable entities to implement an information system policy that meets certain requirements, in addition to the development of systematized processes for the release of patient tests and reports, privacy and confidentiality policy, and access control to patient and professionals’ data and information.

Confirming the progressive nature of the norm, new concepts, and rules regarding the organization, contracting, management, physical infrastructure, process management, risks and waste, and other aspects related to such entities are also introduced.

Furthermore, the Resolution brings new definitions (e.g., itinerant laboratory test service and primary biological material) and updates others in comparison with the prior regulations, with particular attention to the biological material or sample nature and methodology developed in-house.

The Resolution will come into force on August 1, 2023. The entities that provide the services within the scope of the Resolution will have one hundred and eighty (180) days from May 10, 2023, to comply with the new rules.

Our Life Sciences team is available to assist you with the matter and to provide any clarification your company may need.