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  • 15 May 2023

Anvisa approves new rules for clinical laboratories

On 5.10.2023 the National Health Surveillance Agency (Anvisa) published  Resolução RDC n° 786/2023, which determines new rules for the functioning of clinical laboratories, pathological anatomy laboratories and other services that carry out Clinical Analysis Examinations (EAC, in Portuguese language).

The new norm revokes Resolution RDC n° 302/2005 and is the result of the Consulta Pública n° 912/2020. The new rules were approved by the Collegiate Board of Anvisa at the 6th Ordinary Public Meeting, which took place on 5.3.2023[1].

The update of the rules for the operation of clinical laboratories was included in Anvisa’s Regulatory Agenda 2017-2020 and was extended to 2021-2023. The review was undertaken because the old standard was based on concepts which are now considered obsolete in the light of new and current technologies, which provide greater agility in exams, patient safety and broad access by the population to clinical diagnosis.

The old norm had regulatory gaps – such as the lack of uniformity of concepts and regulation of quality control of exams, rapid tests and collection warehouses – as well as the absence of setting technical requirements for in-house methodologies[2].

Regarding the renewal of the rules, the Agency was inspired by other countries and held a Sectorial Dialogue with the participation of Municipal Sanitary Surveillance, Associations and laboratories, and was open to public consultation and the regulated sector. Several institutions took part including the National Council of Health Secretaries (CONASS), the Ministry of Health, the Brazilian Association of Diagnostic Medicine (Abramed), the Federal Council of Biomedicine (CFBM), and the Federal Council of Medicine (CFM).

According to Anvisa, the changes can be divided into two main groups: (i) modernization in terms of the functioning of clinical laboratories and points for collection and performance of EACs and (ii) the expansion of EACs activities beyond the structures of laboratories and collection points. Among the changes are the following highlights:

  • Scope of coverage: expanded to include other types of laboratories (such as anatomopathological and toxicology) and restricted to EAC services in biological material of human origin.
Previous coverage

(RDC n° 302/2005)

New coverage

(RDC n° 786/2023)

Public or private services that carry out laboratory activities in the area of clinical analysis, clinical pathology and cytology[3]. Legal entities, under private or public, civil or military law, who carry out activities related to EACs[4]. However, this does not apply to the use of self-test products[5].
  • EACs in pharmacies: It is now allowed to perform EAC in pharmacies by way of screening and in isolated offices. However, the results of these tests cannot be used in isolation for decision-making.
  • Categorization: creation of categorization of EAC services according to the table below, with type I and II services complementary to tests performed by laboratories. These cannot be used in isolation for decision making.
Type Service Establishment
Service type I EAC activities must: (i) use a product for invitro diagnosis that requires primary biological material and with exclusively visual reading, but that does not depend on an instrument for interpretation or visualization of the result, and (ii) perform all stages of the exams in the same establishment Pharmacies and health assistance establishments
Service type II Activities aimed at (i) the receipt, storage, packaging, processing and transport of biological material, (ii) the collection of biological material, (iii) the performance of face-to-face EAC, (iv) the itinerant and home collection service, (v) performance of services allowed for type I service, and (vi) transcription of the report, as long as it guarantees traceability of the service. Collection points (screening and complementary tests)
Service type III Services authorized to perform (i) all EACs, (ii) collection, receipt, storage, packaging and transport of biological material, and (iii) itinerant and home collection service. Clinical laboratories, support, and pathological anatomy laboratories
  • Distribution centers: definition of technical parameters for the operation of biological material distribution centers, such as (i) presence of a technician in charge, (ii) recording of temperature, humidity, exposure to light, validity and other conditions, and (iii) structure requirements physical (such as locker rooms, material disposal container, purges, etc.).
  • Link between collection points and clinical laboratories: provision that social or contractual link between a collection point and a laboratory, the former being responsible for (i) sample collection, (ii) storage, (iii) carrying out tests allowed for type I services, and (iv) tests in person.
  • Traceability: definition of more specific requirements for the traceability of all activities related to the material (from collection to disposal).
  • Own methodologies for clinical laboratories: Only Type III Services can use their own methodology. This requires proper documentation and must be suitability demonstrated through scientific grounds. The laboratory must specify in the reports which results were obtained using its own methodology.

Resolution RDC nº 786/2023 will come into effect on August 1, 2023. The affected services will have a period of 180 days – from the date of publication – to adapt to the new rules, and the determinations related to the physical infrastructure must be met when reforms or expansions of existing services are carried out.

Non-compliance with the new rules constitutes a sanitary infraction and may result in the sentence provided for in Law No. 6,437/1977, without prejudice to applicable civil, administrative and criminal responsibilities.

[1] The Meeting can be watched in full on Youtube through the following link: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/acompanhe-a-reuniao-publica-da-diretoria-da-anvisa-nesta-quarta-feira-3-5

[2] In-house methodologies are defined by the new Resolution as the “analytical methodology, reagents or analytical systems developed, produced and validated by the Type III Service for use in its environment, which can be applied in research or in support of diagnosis and therapy” (art. 6, item XXVII).

[3] Item 3 of RDC Resolution No. 302/2005

[4] Are those that “include, but are not limited to, biological, microbiological, immunological, chemical, biochemical, immunohematological, hematological, cytological, anatomopathological, genetic, molecular biology, cellular biology, mycology, parasitology, toxicology , urinalysis or other tests on biological material of human origin” (art. 3 of RDC No. 786/2023).

[5] RDC articles 2 to 4 No. 786/2023).

Lefosse’s Life Sciences & Healthcare Team closely monitors the changes that impact the Brazilian Market. For further clarification on this matter, or others that may be of interest to you, contact our professionals.

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