Regulatory Update
from Anvisa – Brazil
Augusto Geyer
Head, Medical Devices Office
Anvisa – Brazilian Heath Regulatory Agency
March 12, 2024
Headquarter in Brasília
Requirements for Market Authorization
of In Vitro Diagnostic Medical Devices
• Final text approved by Anvisa Collegiate Board on 6
December 2023
• Harmonized within Mercosur
• RDC 830/2023
• Effective on 1st June 2024
• Update of the documentation required for submission
• Electronic Instructions for Use requirements
• Updated definitions and classification rules
• IMDRF/IVD WG/N64 FINAL:2021 – Principles of In Vitro
Diagnostic (IVD) Medical Devices Classification
Clinical Investigations Requirements
• Final text approved by Anvisa Collegiate Board
on 13 December 2023
• RDC 837/2023
• Effective since 15 December 2023
• Alignment of the Brazilian regulatory scenario with
international practices
• Simplification of the process of submitting
documentation
• Adoption of a convergent terminology in relation to
the development of medical devices
EP of Safety and Performance
• Final text approved by Anvisa Collegiate
Board on 6 March 2024
• Harmonized within Mercosur
• RDC XYZ/2024
• Effective 180 days after its publication
• Based on IMDRF document – Essential
Principles of Safety and Performance of Medical
Devices and IVD Medical Devices (IMDRF/GRRP
WG/N47FINAL:2018)
Medical Device Licenses in Brazil
Number of MD Market Authorizations per Year
2021 2022 2023
Notification Class I 3102 2718 2711
Class II 3443 3751 4162
Registration Class III 938 1014 718
Class IV 254 328 300
Total 7737 7811 7891
Active Licenses
of Medical Devices
87.758
(31 December 2023)
Reliance Mechanisms for Market
Authorizations
• Pathway for abridged review of initial submissions
• Public Consultation 1200/2023 closed on 25 October 2023
• Normative Instruction proposal submitted to the Reporting Director
• Main objectives
• Market authorization certificates from Equivalent Foreign Regulatory
Authorities will be accepted for expedited review for the grant of Market
Authorization in Brazil (registration)
• Initially from the founding members authorities of MDSAP
• Expectation to be published and made effective by the second
quarter of 2024
Use of MDSAP by Anvisa
• MDSAP Audit Reports are accepted for granting Anvisa GMP
Certificates
• The Audit Reports are reviewed and they need to cover all requirements in
RDC 665/2022
• MDSAP Certificates started to be accepted for the renewal of
Anvisa GMP Certificates (pilot programme started late 2023)
• Simple review of the Certificate to optimizes the renewal process
• Increase in the GMP Certificate validity from 2 to 4 years if
based on MDSAP documents
• Revision in process after Public Consultation 1208/2023 – expectation to
publish the RDC in the first quarter of 2024
Use of MDSAP by Anvisa
Anvisa GMP Certificates Issued using MDSAP
Year # GMP Certificates Issued Based on
MDSAP Reports (% of total)
2017 38 (4.7%)
2018 107 (19,3%)
2019 374 (48,7%)
2020 544 (49,1%)
2021 529 (51,4%)
2022 621 (59,7%)
2023 659 (59,1%)
MDSAP Forum hosted by Anvisa
Brasília, 23 – 27 October 2023
Data Transparency
• GMP Certification Database
• Relevant search criteria
• Geographic distribution views available
• Certification status filters
• Constantly updated (weekly basis)
• Widely helpful to management
Dashboard link:
https://www.gov.br/anvisa/pt-br/setorregulado/certificados-de-boas-
praticas/consultar-empresas-certificadas
Data Transparency
• Data Dashboard of issued GMP
Certificates
https://app.powerbi.com/view?r=eyJrIjoiYTYzNDM0ZDEtNzkxNC00OD
NlLTkwNDAtMjZjMTFjOWVjMTkwIiwidCI6ImI2N2FmMjNmLWMzZjMtNG
QzNS04MGM3LWI3MDg1ZjVlZGQ4MSJ9
• Data Dashboard of Anvisa
Inspections – Medical Devices
Microsoft Power BI
Anvisa’s 25th Anniversary Celebration
The Agency
celebrates 25
years of
contributions to
public health and
to the quality of
life of Brazilian
citizens
