IMDRF Stakerholder Open Forum
Regulatory Updates
Brazil
13 September 2022
Australia
Ana Carolina Moreira Marino Araujo
General Manager – Office of Inspection and Law Enforcement
Brazilian Health Regulatory Agency
ANVISA
Software as Medical Device Regulation
Resolution RDC No. 657/2022
Provides guidande for regularization of Softwares a Medical Device (SaMD).
Resolution came into force on 1 July 2022
Based on IMDRF documents:
• Software as a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:2013) (IMDRF, 2013)
• Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations
(IMDRF/SaMD WG/N12FINAL:2014) (IMDRF, 2014)
• Software as a Medical Device (SaMD): Application of Quality Management System (IMDRF/SaMD WG/N23
FINAL:2015) (IMDRF, 2015)
• Software as a Medical Device (SaMD): Clinical Evaluation (SaMD WG (PD1)/N41R3) (IMDRF, 2017)
• Principles and Practices for Medical Device Cybersecurity (IMDRF/CYBER WG/N60FINAL:2020)
Software as Medical Device Regulation
Resolution RDC No. 657/2022
Provides requirements for regularization of Softwares a Medical Device (SaMD), including:
• Software updating procedures as well as minimal hardware and software requirements
• Interoperability specifications, compatibilities and incompatibilities, as well as technology environments
• Cybersecurity information
The new RDC 657/2022 makes clear which software types do not fall under the new regulation, such as:
• Software for well-being of users
• Software used only for administrative and financial purposes within healthcare organizations
• Software to process demographic and epidemiological medical data without providing any diagnostic or
therapeutic function
Essential Principles of Safety and Performance of
Medical Devices and IVD Medical Devices
Public Consultation will be opened in the following days, it was approved August 31st
Contribution period will be 60 days counting from the publication date
Expected approval of the final document: Q1 2023
Based on IMDRF documents:
• Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
(IMDRF/GRRP WG/N47FINAL:2018) (IMDRF, 2018)
Main objectives:
• The purpose is to update safety and performance requirements of MD and IVDMD and to restructure
the previous regulation in line with the Good Regulatory Practices
• Inclusion of specific requirements for new technologies
• Alignment of requirements for Mercosur jurisdictions
Clinical Investigations Requirements Revision
The Revision Procedure of RDC No. 10/2015 has been approved.
Main objectives:
• Decrease regulatory cost
• Adoption of definitions converging with ISO14155:2020
• Clarification about clinical investigations that must be submitted to Anvisa for
approval before the start of study activities
Public Consultation is expected in the coming months.
Regulatory Updates
Resolution RDC No. 665/2022
Brazilian Technical Regulation for Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic
Devices
No Major Changes, it was published to attend a Presidential Decret for harmonization of the format of
legislation.
• Revoked RDC Nº 16/2013
• No changes in the Requirements
• Only editorial changes
Regulatory Updates
Resolution RDC No. 687/2022
Establishes criteria for issuing and renewing Good Manufacturing Practices for Medical Devices Certificates
Major Changes:
• Revoked RDC Nº 183/2017
• Simplified the documentation that should be presented
• Adds additional Facilities that requires GMP Certification, for exampled: IVD manufacturing unit that
perform specific manufacturing steps, such as cutting, impregnation or lamination of
immunochromatography strips
• 3 possible pathways for granting GMP Certification
• Risk Matrix that defines desk review certification or the need for an in-person inspection is now publicly
available at Anvisa’s website
Use of MDSAP Reports by ANVISA
2017 38 Certificates Issued ( 4.7%)
2018 107 Certificates Issued (19,3%)
2019 374 Certificates Issued (48,7%)
2020 544 Certificates Issued (49,1%)
2021 529 Certificates Issued (51,4%)
2022 389 Certificates Issued (until July 31th)
8
THANK YOU!
Ana Carolina Moreira Marino Araujo
General Manager
Office of Inspection and Law Enforcement
Agência Nacional de Vigilância Sanitária - Anvisa
SIA Trecho 5 - Área Especial 57 - Lote 200
CEP: 71205-050
Brasília – DF – Brasil
www.anvisa.gov.br
www.twitter.com/anvisa_oficial
Anvisa Atende: 0800-642-9782
ouvidoria@anvisa.gov.br
