Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

2. Latin American regulations - Brazil

3. Latin American regulations - Brazil
1 – Potential Market Brasil in 2021
2 – Medical device market
3 - Main topics of the Brazilian Public Bidding Law
4 – The role of the National Health Surveillance Agency – ANVISA
5 - Main standards published by ANVISA
6 – How to follow the future changes of ANVISA regulations?
7 – Regulatory path for product legalization – What is notification and
registration?
8 – Brazil Registration Process
9 – Who can be the Registration Holder?
10 – Other certificates

4. 1 – Potential Market Brazil in 2021
ü Annual GDP increase 4.6%;
ü GDP in US$ 1.61 trillion;
ü GDP per capita US$ 7,518.8
ü Total population of 213,993,441;
ü Foreing direct investment, net inflows (% of GDP) US$ 2,6 (2020)
ü Central Bank predicts GDP growth of 2% by the end of 2022

5. 2 – Medical device market
ü It is the eighth largest healthcare market in the world;
ü According to the Brazilian Association of the Medical Devices Industry (ABIMO), the
medical device sector is estimated at R$ 33.1 billion;
ü From January to December 2020:
ü Medical device exports = US$760,541,719;
ü Medical Device Imports = US$4,614,566,401;
ü From January to August 2021, even during the Covid-19 pandemic:
ü Medical device exports = US$488,575,206;
ü Imports = US$ 3,535,781,334;

6. ü Bidding Law No. 8,666 of June 21, 1993,
establishes rules for public administration
bids and contracts
ü New Bidding Law, Law No. 14,133 of April,
1st, 2021 that deals with bidding and
administrative contracts
3 - Main topics of the Brazilian Public Bidding Law
Main changes introduced by the New Bidding Law:
ü It facilitated the access of foreigners to public purchases;
ü Foreigners may register at the SICAF, the Unified Registration System
for Federal Government Suppliers1;

7. Main changes introduced by the New Bidding Law:
ü Preparation of the Brazilian environment for the GPA (Agreement on Government
Procurement) of World Trade Organization (WTO) 2;
ü Mandatory publication in the National Public Contracting Portal (PNCP)3 ;
ü It abolished formalities of prior legalization of documents4;
ü Foreign companies can now lead Consortium with Brazilian companies;
ü The most demanded area of contracting by the Brazilian government with foreigners is
medical devices5;
Law n.˚ 8.666/93 x Law n.˚ 14.133/21
3 - Main topics of the Brazilian Public Bidding Law

8. 4 – The role of the National Health Surveillance Agency – ANVISA
The main attribution is to promote the
protection of the health of Brazilians.
“Art. 6 The Agency will have the institutional
purpose of promoting the protection of the
population's health, through the sanitary control
of the production and commercialization of
products and services subject to sanitary
surveillance, including the environments,
processes, inputs and technologies related to
them, as well as the control of ports, airports
and borders”.

9. 4 – The role of the National Health Surveillance Agency – ANVISA
ü Created by Law No. 9,782, of January 26, 1999, which defines the national policy and
the Health Surveillance system;
ü Institution of the Federal Government linked to the Ministry of Health it has
Economic, Technical and Administrative autonomy;
ü Goal of standardizing, controlling and inspecting products and services of interest to
health such as medicines, vaccines, medical devices, IVD, food, beverages, cosmetics,
pesticides, Tobacco Products, sanitizing products;
ü Exercises Health Surveillance at ports, airports and borders to control potential health
risks;
ü It AUTHORIZES, PROHIBITS or CREATES CONSUMPTION RULES

10. 4 – The role of the National Health Surveillance Agency – ANVISA
• Composed by a Collegiate Board of Directors with 5 boards

11. 5 - Main resolutions published by ANVISA
Medical device:
Class I and II - Notification
RDC 40/2015 – Medical device in general
RDC 36/2015 - IVD
Class III and IV – Registration pathway
RDC 185/2001 – Medical device in general
RDC 36/2015 – IVD
Brazilian Good Manufacturing Practice
RDC 665/2022 and RDC 687/2022
ANVISA provides libraries with all the standards relevant to
medical devices and is in https://www.gov.br/anvisa/pt-
br/assuntos/regulamentacao/legislacao/bibliotecas-
tematicas/arquivos/produtos

12. ü ANVISA's Regulatory Agenda (AR) 1;
ü It results in normative acts (RDCs, INs or non-normative regulatory instruments
(guides, manuals, “questions and answers”);
ü During the regulatory process, the collaborative participation of the entire population
is encouraged, for this it is important to monitor the development of the Agenda's
regulatory projects2;
ü There are 22 MD themes that can be found at // https://www.gov.br/anvisa/pt-
br/assuntos/regulamentacao/agenda-regulatoria/agenda-2021-
2023/arquivos/atualizacao_2022/portal_atualiza_lista_final_ar_2021-2023.pdf
6 – How to follow the future changes of ANVISA regulations?

13. NOTIFICATION:
ü Notification is a simplified way of registering the product for risk classes I and II;
ü ANVISA approval is automatic and published in approximately 15 – 30 days on the
website itself;
ü Processes are analyzed by sampling and may be rejected without notice;
ü The registration is valid for an undefined period;
REGISTRATION:
ü Registration is the path used for risk class III and IV products;
ü Requires GMP Certification;
ü Valid for 10 years and can be renewed for equal periods;
ü Analysis time at ANVISA varies between 30 days for equipment and IVD and materials
can reach 180 days;
7 – Regulatory path for product legalization – What is notification and registration?

15. Only companies established in the country and that have all licenses and
ANVISA’s Company Operating Permit to IMPORT or MANUFACTURE medical
devices can apply for product registration.
- Distributor;
- Company opening;
- Purchase of Shelf Company;
- Hosting company.
9 – Who can be the Registration Holder?

16. Certificate of Good Manufacturing Practices - BGMP
- For MD, IVD and Softwares (SaMD) manufactures of Risk Class III and IV products;
- For manufacturing site that produces a finish device in its name or for another company;
- Manufacturing site that is responsible for releasing the finished device, related to at
least one production stage, except for designing, shipping, sterilization, packing and
labeling stages;
- For certification via on-site audit could take from 6 months for more than 365 days;
- MDSAP route takes 30 to 60 days for analysis;
- Valid for 2 years and can be renewed for equal periods;
10 - Other certificates

17. Certification at National Institute of Metrology, Standardization and Industrial Quality
- INMETRO
ü All medical equipment manufactured or imported into Brazil that has at least one of
the standards listed in ANVISA Normative Instruction 49/2019 and is applicable to
the equipment.
ü INMETRO, through certification, guarantees that the technical requirements of the
equipment strictly follow the international IEC requirements, combined with the
Brazilian requirements.
Certification at National Telecommunications Agency - ANATEL:
ü Ensures the telecommunications security of medical devices and/or their accessories
that have wireless telecommunications modules, such as bluetooth, wifi, mobile
interface, listed in Act N˚ 7.280/2020.
10 - Other certificates

18. Thank you!
Marcelo Brisolla
CEO Brisa Advisors & BIHS Registration Hosting company.
+55 21 98823-0888
Marcelo@brisa.com.br