RDC 978/2025 ANVISA
Check out the simple guide for you to consult some of the main guidelines of RDC 978/2025 ANVISA for the clinical laboratory.
The material will be very useful for you to present to your coordinator, demonstrating how valuable it is to use a tool that boosts your internal control and keeps the laboratory in compliance with legislation.
Remembering that RDC 978/2025 is already in force and establishes a period of 90 days from 06/10/2025 for the adaptation of clinical laboratories.
Resolution of the Collegiate Board of Directors — ANVISA
RDC 978/2025 no
Clinical Laboratory
Check the main guidelines determined by RDC 978/2025 for the clinical laboratory. This resolution revokes RDC 786/2023:
In effect from 06/10/2025.
90-day deadline for the laboratory to adapt.
Chapter V — Section I
Quality Assurance Program (QPG)
Art. 86. The PGQ must cover: technology management, risk management, document control, personnel management and continuing education, operational process management and Quality Control Management.
Art. 87. Quality Control Management documentation must include monitoring of effectiveness through performance indicators by the Technical Responsible. The Service must compare performance indicators with available programs or up-to-date scientific references.
Chapter V — Section II
Technology Management
Art. 88. All products subject to health surveillance used by the Service must be regularized with Anvisa, and used exclusively for the purposes set out in the manufacturer's instructions for use.
Art. 92. Preventive and corrective maintenance of equipment must be recorded in accordance with the instructions for use.
- § 1 In the absence of a manufacturer's definition regarding the frequency of preventive and corrective maintenance, this must be established by the Service that performs EAC, and must be carried out at least annually.
Chapter VII
Quality Control Management (GCQ)
Art. 171. The Service must ensure the reliability of the EAC through GCQ.
Art. 172. GCQ comprises, at a minimum, Internal Quality Control (IQC) and External Quality Control (CEQ).
Art. 173. The IQC and CEQ must be carried out exclusively in the Service that carries out the EAC (on site).
Art. 176. The GCQ documentation must include:
- I — list of all tests performed;
- II — form of control and frequency of use;
- III — limits and acceptability criteria for control results;
- IV — evaluation and recording of control results;
- V — annual CEQ performance report provided by the Proficiency Testing Provider.
Chapter VII — Section I
Internal Quality Control (IQC)
Art. 177. All Services must participate in IQC programs.
Art. 179. The Service must carry out IQC for all equipment in use.
Art. 180. The IQC must cover all analytes analyzed, including:
- I — monitoring the analytical phase by analyzing the control sample, recording the results obtained and analyzing the data;
- II — definition of criteria for acceptance and rejection of results by type of analyte and according to the methodology used;
- III — release or rejection of analyzes after evaluating the results of control samples;
- IV — investigation of inadequacies with recording of causes and corrective actions taken;
- V — criteria for evaluating and recording the results of Quality Controls.
Art. 183. For EAC carried out with single-use in vitro diagnostic products, IQC must be carried out, at least, at each batch change, each shipment and in accordance with the manufacturer's instructions. For EAC carried out with equipment, IQC must be carried out after preventive and corrective maintenance. For other EACs, IQC must be carried out, at least, by analytical run according to the manufacturer's specifications, and after maintenance.
Chapter VII — Section II
External Quality Control (CEQ)
Art. 185. All Services must participate in CEQ programs.
Art. 187. The Service must carry out the CEQ for all equipment in use.
Art. 189. The Service must verify the minimum annual availability of proficiency testing for tests carried out with Proficiency Testing Providers. For tests not included in CEQ Programs, the Service must adopt alternative ways of evaluating the accuracy of the analytical system described in scientific literature.
ANVISA's RDC 978/2025 revokes RDC 786/2023 and requires an appropriate tool to meet the strictest Internal Control criteria. The IQC process carried out with QualiChart reduces the time spent on the daily control routine by 85%.
