RDC No. 611 and ANVISA Normative Instructions for Diagnostic and Interventional Radiology Services
Brazilian Regulatory Decree No. 611/2022 establishes the sanitary requirements for the organization and operation of diagnostic or interventional radiology services and regulates the control of medical, occupational, and public exposures resulting from the use of diagnostic or interventional radiological technologies.
Resolution RDC No. 611, of March 9, 2022
Resolution RDC No. 611/2022 is part of ANVISA's 2021–2023 Regulatory Agenda (Project 1.2), aligned with Decree No. 10,139/2019, which establishes guidelines for the consolidation and simplification of regulations, without promoting substantive changes. Thus, RDC No. 611/2022 consolidates and revokes RDCs No. 330/2019 and No. 440/2020.
Normative Instructions - IN
Normative Instruction – IN No. 90/2021 - Conventional medical radiography systems
This law establishes sanitary requirements to ensure quality and safety in conventional medical radiography systems, and provides other related measures.
Normative Instruction – IN No. 91/2021 - Fluoroscopy and Interventional Radiology Systems
This law establishes sanitary requirements to guarantee the quality and safety of fluoroscopy and interventional radiology systems, and provides other measures.
Normative Instruction – IN No. 92/2021 - Mammography Systems
This law establishes sanitary requirements to guarantee the quality and safety of mammography systems, and provides other related measures.
Normative Instruction – IN No. 93/2021 - Medical computed tomography systems
This law establishes sanitary requirements to ensure quality and safety in medical computed tomography systems, and provides other measures.
Normative Instruction – IN No. 94/2021 - Extraoral dental radiology systems
This law establishes sanitary requirements to guarantee quality and safety in extraoral dental radiology systems, and provides other related measures.
Normative Instruction – IN No. 95/2021 - Intraoral dental radiology systems
This law establishes sanitary requirements to ensure quality and safety in intraoral dental radiology systems, and provides other related measures.
Normative Instruction – IN No. 96/2021 - Diagnostic or interventional ultrasound systems
This document establishes sanitary requirements to guarantee quality and safety in diagnostic or interventional ultrasound systems, and provides other related measures.
Normative Instruction – IN No. 97/2021 - Nuclear magnetic resonance systems
This law establishes sanitary requirements to ensure quality and safety in nuclear magnetic resonance imaging systems, and provides other related measures.
Resolution RDC No. 50, of February 21, 2002 - ANVISA
This document establishes the Technical Regulation for the planning, programming, development, and evaluation of physical projects for healthcare facilities.