Resolution of the Collegiate Board of Directors — ANVISA
RDC 978/2025 came into force in June 2025, replacing RDC 786/2023 and raised many questions for clinical laboratory professionals. This guide brings together the most frequently asked questions, with answers based on the normative text of RDC 978/2025 and the Questions & Answers Document published by ANVISA (GGTES/GRECS, August 2025).
Level: Intermediate — suitable for Technical Managers, Quality Managers and professionals who need to adapt laboratory routines to the new standard.
1. About RDC 978/2025
What is RDC 978/2025 and when did it come into force?
Resolution of the Anvisa Collegiate Board No. 978, of June 6, 2025, is the current health regulation for all Services that perform Clinical Analysis Exams (EAC) in Brazil. It came into force on June 10, 2025. It fully revoked RDC 786/2023, incorporating editorial and organizational improvements demanded by the sector.
Did RDC 978/2025 also repeal RDC 302/2005?
Not directly. RDC 302/2005 had already been revoked by RDC 786/2023 in August 2023. RDC 978/2025 revoked RDC 786/2023 (Art. 193). The full revocation history is:
- RDC 302/2005 — pioneering standard, valid from 2005 to 2023;
- RDC 786/2023 — revoked 302/2005, in force from 2023 to 2025;
- RDC 978/2025 — revoked 786/2023, the regulation in force today.
The standard that must be followed today is exclusively RDC 978/2025.
To which services does RDC 978/2025 apply?
The standard applies to all establishments that perform EAC on human biological samples: clinical laboratories, pharmacies, medical clinics, isolated offices, collection points, hospitals and itinerant services. The framework does not depend on size, but on the execution of EAC.
Why was RDC 786/2023 replaced so quickly?
The replacement was motivated by implementation difficulties identified during the validity of RDC 786/2023. Anvisa coordinated technical groups with representatives from the public sector (Ministry of Health, state and municipal health surveillance) and the regulated sector (SBP, SBPC/ML, SBAC, Abramed, Abrafarma, Controllab, PNCQ and others) to discuss the necessary adjustments. RDC 978/2025 brings greater clarity to requirements that generated divergent interpretations — especially in the areas of IQC, CEQ, PGQ and service classification.
2. Service Types and Classification
How does RDC 978/2025 classify services that perform EAC?
The standard maintains four types of service:
- Type I Service (STI): pharmacies and isolated offices, which perform screening EAC (e.g.: capillary blood glucose);
- Type II Service (STII): medium-sized clinical laboratories, with collection and execution of quantitative EAC;
- Type III Service (STIII): highly complex laboratories, with all phases of the analytical process;
- Itinerant Service: services that perform EAC in locations other than the headquarters.
Each type has specific infrastructure, human resources and quality control requirements.
Are pharmacies and drugstores classified as Type I Service?
Yes. Pharmacies with and without compounding can be classified as Type I Service, as long as the applicable health requirements are met. The pharmacist performs screening RCTs — which do not have confirmatory diagnostic purposes — as a pharmaceutical assistance action.
Does the parent/branch relationship change the obligations of each service?
No. The head office/branch relationship is a form of legal and fiscal organization. Each Service that performs EAC must individually comply with all the requirements of RDC 978/2025, regardless of its classification as headquarters or branch.
Is a doctor's order necessary to perform EAC?
No. A doctor's request, or that of any other health professional, is not a health requirement for the execution of EAC by RDC 978/2025.
3. Technical Responsibility and Supervision
Is the physical presence of a qualified professional necessary throughout the operation?
Yes. Art. 122 of RDC 978/2025 determines that the Service must have a legally qualified professional as supervisor of technical personnel, in person, throughout the period of operation. In case of impediment, there must be a legally qualified substitute.
Can the Technical Manager (RT) be responsible for supervising technical staff?
Yes. There is no regulatory impediment to the accumulation of functions by the same professional, as long as the provisions related to each function within the scope of the respective Professional Class Council are observed.
Which professionals can be RTs in services that perform EAC?
The Professional Class Councils are responsible for defining the duties and limits of each category qualified to exercise Technical Responsibility within the scope of services that perform EAC. Anvisa does not provide for professional practice. It is recommended to consult the Class Council relevant to your category.
4. Internal Quality Control (IQC)
Can IQC be performed off-site by a reference laboratory?
No. Art. 171 of RDC 978/2025 determines that the IQC must be carried out exclusively in the service itself (on-site), on all equipment in use. It is not possible to delegate the execution of the IQC to another establishment.
How often should IQC be performed?
Art. 183 of RDC 978/2025 requires that IQC be carried out in every analytical run. This means that whenever patient samples are analyzed, the control material must be processed together, using the same equipment and conditions.
What changed in Art. 180 in relation to the old Art. 147 of RDC 786/2023?
Art. 180 of RDC 978/2025 expanded the mandatory items of the IQC from 3 to 5:
I – monitoring of the analytical phase by analyzing the control sample, with recording of the result and analysis of the data;
II – definition of acceptance and rejection criteria by analyte and methodology;
III – release or rejection of analyzes after evaluating the results of control samples;
IV – recording of inadequacies, investigation of causes and actions taken for rejected results;
V – criteria for evaluating the results of control samples.
Items IV and V are new in relation to RDC 786/2023 — item IV formalizes the obligation to document critical analysis and corrective actions; item V makes the need for defined evaluation criteria explicit.
Is there a requirement to verify the batch certificate (batch by batch) of the control material?
Yes. Article 184 of RDC 978/2025 introduced a requirement, new in comparison with RDC 786/2023, to check and record the lot certificate for control materials used in IQC. This lot-by-lot procedure allows the laboratory to confirm that the values for a new lot correspond to the expected performance before putting it into routine use.
5. External Quality Control (CEQ)
Is CEQ mandatory for all types of service?
Yes. RDC 978/2025 maintains the mandatory CEQ for all types of service (STI, STII, STIII and Itinerant). CEQ must be performed in situ, using the same equipment and conditions used for patient samples.
How often should the CEQ be performed?
Art. 187 of RDC 978/2025 requires that the CEQ be carried out at least four times a year for the analyzed analytes, with distribution covering the entire working day of the service.
Can a reference laboratory perform CEQ on behalf of another service?
No. Like IQC, the CEQ must be carried out on-site, at the service itself, by service professionals and on the equipment in use. Delegation of the CEQ to another establishment is not permitted by RDC 978/2025.
6. Quality Management Program (PGQ)
What is PGQ and who should implement it?
The Quality Management Program (PGQ) is the documented set of policies, processes and procedures that guarantee the reliability of the EAC. According to Arts. 86 and 87 of RDC 978/2025, the PGQ is mandatory for all services, including Type I Services. It must cover at least: management of technologies, risks, documents, personnel, operational processes, IQC and CEQ.
How long should IQC and CEQ records be kept?
Art. 174 of RDC 978/2025 requires that IQC records be kept for at least 5 years. CEQ records must be maintained for a period compatible with traceability and auditing requirements. Spend time organizing and digitizing these records — in inspection, the absence of documentary history is an immediate non-compliance.
Is metrological traceability required by RDC 978/2025?
Yes. The Arts. 100 and 101 of RDC 978/2025 require metrological traceability for measuring equipment in use. This includes maintaining documented calibrations, checks, and records of instruments that directly impact EAC results.
7. Transitional Provisions and Amendments
What was the deadline for adapting to RDC 978/2025?
Art. 191 of RDC 978/2025 established a period of 90 days for services already in operation to adapt. Considering that the standard came into force on June 10, 2025, the deadline ended in September 2025. Services still in the process of adaptation are subject to inspection and penalties provided for in Law No. 6,437/1977.
What did RDC 986/2025 change in RDC 978/2025?
RDC 986, of August 15, 2025 (published on 08/19/2025), brought specific adjustments to the text of RDC 978/2025. The Question Paper & ANVISA Answers (1st edition, August 2025) already incorporates these changes. It is always recommended to consult the current consolidated text on the AnvisaLegis Portal to check the updated version of the standard.
How to access the official text of RDC 978/2025 and the Questions document & Answers from ANVISA?
RDC 978/2025 is available on the Anvisa Legislation Portal (AnvisaLegis). The official Questions & Answers document (GGTES/GRECS, 1st edition, August 2025) is available on the gov.br/anvisa portal, in the Health Services > Publications section.
Keeping up to date with current regulations is a technical and ethical responsibility of the clinical laboratory professional. Compliance with RDC 978/2025 is not just a legal requirement — it is the guarantee that the results delivered to your patients are reliable and safe. The quality of results is the responsibility of clinical laboratory professionals, in their different roles.
QualiChart follows this regulatory evolution and offers tools that automate IQC recording (including batch-to-batch verification), document traceability and facilitate critical analysis according to the requirements of the standard. Discover our free demo program at .
