FAQ
Frequently Asked Questions
The first step is to choose the local registration holder to act as the official representative for the process with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency).
Only Brazilian importing, distributing and/or manufacturing companies duly certified by ANVISA, with a Sanitary License and an Operating License (AFE - Autorização de Funcionamento de Empresa - Business Operating License), are authorized to register health products in Brazil. Therefore, foreign manufacturers must seek a certified distributor or importer — or, preferably, a specialized company that acts as a Registration Holder, such as WeRegister — to be the nominal holder of the registrations.
Through the registration hosting service, the manufacturer retains the legal title — that is, the ownership — of their product registrations. This allows the manufacturer to authorize or deauthorize distributors throughout Brazil according to market demands, using only one single registration for each product or family of products.
When hosted with WeRegister, the registrations remain under the secure management of the manufacturer, ensuring independence, freedom and agility to meet market needs, establish new commercial partnerships, and adjust distribution partners and strategies.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 830, dated December 6, 2023, published in the Diário Oficial da União (Official Gazette) No. 234, on December 11, 2023.
It establishes the risk classification, notification and registration regimes, and the requirements for labeling and instructions for use of in vitro diagnostic medical devices, including their instruments.
The timeline for obtaining registration of an imported IVD product with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency) ranges from 2 to 23 months, depending on the product’s risk class and the certifications and testing required.
I and II
III and IV
1. Risk Classes I and II — Notification
For products in Classes I and II, the registration process is called Notification.
- Requirements: Neither certification of the foreign company nor prior product testing outside of Brazil are required.
- Approval time: The average approval time is 2 to 3 months, counted from the submission of the application to ANVISA.
2. Risk Classes III and IV — Registration
For products in Classes III and IV, the process is called Registration.
- Requirements: obtaining, before submission, the International Good Manufacturing Practices Certification from ANVISA.
This certification can currently be obtained in two ways:
A. Manufacturer has the MDSAP certificate (Medical Device Single Audit Program)
- Approval time: The International GMP Certification is approved in 1 to 2 months, without the need for an ANVISA audit at the foreign factory. After submission of the International GMP, the products can be submitted for registration.
B. Manufacturer does not have the MDSAP certificate
- Approval time: The International GMP Certification is approved in 9 to 15 months, depending on the product. ANVISA will perform an on-site inspection at the manufacturing plant.
Requests for registration of Class III and IV products may be filed before the International GMP Certification is concluded, provided they include proof of the application protocol and process number for the certification request. However, the registration analysis will only begin after the International GMP Certification is approved.
C. After obtaining the International GMP Certification
After certification, the average time for registration analysis varies according to the requirement for analysis of the product by the INCQS (Instituto Nacional de Controle de Qualidade em Saúde - National Institute of Quality Control in Health):
- Approval time without INCQS analysis: 3 to 5 months.
- Approval time with INCQS analysis: 5 to 8 months.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 751, dated September 15, 2022, published in the Diário Oficial da União (Official Gazette) No. 180, on September 21, 2022.
It provides for the risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use of medical devices (MD).
The timeline for registering an imported medical device (MD) with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency) ranges from 2 to 30 months, depending on the product’s risk class and the certifications and testing required.
At the beginning of the process, it is determined whether or not certification by INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia - National Institute of Metrology, Quality and Technology), is required. If certification is necessary, an entity called Organismo Certificador de Produto - OCP (Product Certification Body) must be hired, and the product(s) must be sent to the company based in Brazil that will act as the official party responsible for the registration process (the registration host, importer, and/or distributor), like WeRegister. This company will then forward the product(s) for testing at the certified laboratories.
In addition to product testing, the manufacturing company must also be inspected by the OCP. The INMETRO certification process takes 4 to 9 months, depending on the type of product, factory locality and the complexity of the tests.
I and II
4 to 9 months
III and IV
1. Risk Classes I and II — Notification
For products in Classes I and II, the registration process is called Notification.
- Requirements: Neither certification of the foreign company nor prior product testing outside of Brazil are required.
- Approval time: The average approval time is 2 to 11 months, counted from the submission of the application to ANVISA, depending on the need for INMETRO certification.
2. Risk Classes III and IV — Registration
For products in Classes III and IV, the process is called Registration.
- Requirements: obtaining, before submission, the International Good Manufacturing Practices Certification from ANVISA.
This certification can currently be obtained in two ways:
A. Manufacturer has the MDSAP certificate (Medical Device Single Audit Program)
- Approval time: The International GMP Certification is approved in 1 to 2 months, without the need for an ANVISA audit at the foreign factory. After submission of the International GMP, the products can be submitted for registration.
B. Manufacturer does not have the MDSAP certificate
- Approval time: The International GMP Certification is approved in 9 to 15 months, depending on the product. ANVISA will perform an on-site inspection at the manufacturing plant.
C. Registration Analysis after GMP and INMETRO certifications
- Requests for registration of Class III and IV products may be filed before the required certifications are concluded, provided they include proof of the application protocol and process number for the certification request. However, the registration analysis will only begin after the required certifications are approved.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 665, dated March 30, 2022, published in the Diário Oficial da União (Official Gazette) No. 62, on March 31, 2022.
It establishes the Good Manufacturing Practices for Medical Devices (MD) and In Vitro Diagnostic (IVD) Products.
No product, reagent, or equipment intended for in vitro diagnostic (IVD) use requires INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia - National Institute of Metrology, Quality and Technology) certification.
Some medical devices (MD), however, do require INMETRO certification. Examples include:
- Sterile single-use hypodermic needles and sterile single-use dental needles;
- Equipment subject to health surveillance requirements;
- Single-use transfusion sets, gravity infusion sets, and infusion sets for use with infusion pumps;
- Pacifiers;
- Breast implants;
- Baby bottles and bottle nipples;
- Male condoms;
- Sterile single-use hypodermic syringes.
No product classified as Medical Devices (MD), Medical Materials or Medical Equipment require INCQS (Instituto Nacional de Controle de Qualidade em Saúde - National Institute of Quality Control in Health) certification.
Only in vitro diagnostic (IVD) products require INCQS certification, such as tests for Dengue, Chikungunya, SARS-CoV-2 (self-tests), and those intended for screening tests in blood banks: reagents for immunohematology (ABO system, Rh system, and irregular antibodies), Hepatitis B and C, Syphilis, HIV, Chagas disease, and HTLV.
The fees for notification, registration, inspection etc., vary according to the size of the company that will hold the registration in Brazil. WeRegister is classified as an EPP (Empresa de Pequeno Porte - Small Business).
The first step is to choose the local registration holder to act as the official representative for the process with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency).
Only Brazilian importing, distributing and/or manufacturing companies duly certified by ANVISA, with a Sanitary License and an Operating License (AFE - Autorização de Funcionamento de Empresa - Business Operating License), are authorized to register health products in Brazil. Therefore, foreign manufacturers must seek a certified distributor or importer — or, preferably, a specialized company that acts as a Registration Holder, such as WeRegister — to be the nominal holder of the registrations.
Through the registration hosting service, the manufacturer retains the legal title — that is, the ownership — of their product registrations. This allows the manufacturer to authorize or deauthorize distributors throughout Brazil according to market demands, using only one single registration for each product or family of products.
When hosted with WeRegister, the registrations remain under the secure management of the manufacturer, ensuring independence, freedom and agility to meet market needs, establish new commercial partnerships, and adjust distribution partners and strategies.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 830, dated December 6, 2023, published in the Diário Oficial da União (Official Gazette) No. 234, on December 11, 2023.
It establishes the risk classification, notification and registration regimes, and the requirements for labeling and instructions for use of in vitro diagnostic medical devices, including their instruments.
The timeline for obtaining registration of an imported IVD product with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency) ranges from 2 to 23 months, depending on the product’s risk class and the certifications and testing required.
1. Risk Classes I and II — Notification
For products in Classes I and II, the registration process is called Notification.
- Requirements: Neither certification of the foreign company nor prior product testing outside of Brazil are required.
- Approval time: The average approval time is 2 to 3 months, counted from the submission of the application to ANVISA.
2. Risk Classes III and IV — Registration
For products in Classes III and IV, the process is called Registration.
- Requirements: obtaining, before submission, the International Good Manufacturing Practices Certification from ANVISA.
This certification can currently be obtained in two ways:
A. Manufacturer has the MDSAP certificate (Medical Device Single Audit Program)
- Approval time: The International GMP Certification is approved in 1 to 2 months, without the need for an ANVISA audit at the foreign factory. After submission of the International GMP, the products can be submitted for registration.
B. Manufacturer does not have the MDSAP certificate
- Approval time: The International GMP Certification is approved in 9 to 15 months, depending on the product. ANVISA will perform an on-site inspection at the manufacturing plant.
Requests for registration of Class III and IV products may be filed before the International GMP Certification is concluded, provided they include proof of the application protocol and process number for the certification request. However, the registration analysis will only begin after the International GMP Certification is approved.
C. After obtaining the International GMP Certification
After certification, the average time for registration analysis varies according to the requirement for analysis of the product by the INCQS (Instituto Nacional de Controle de Qualidade em Saúde - National Institute of Quality Control in Health):
- Approval time without INCQS analysis: 3 to 5 months.
- Approval time with INCQS analysis: 5 to 8 months.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 751, dated September 15, 2022, published in the Diário Oficial da União (Official Gazette) No. 180, on September 21, 2022.
It provides for the risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use of medical devices (MD).
The timeline for registering an imported medical device (MD) with ANVISA (Agência Nacional de Vigilância Sanitária - National Health Regulatory Agency) ranges from 2 to 30 months, depending on the product’s risk class and the certifications and testing required.
At the beginning of the process, it is determined whether or not certification by INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia - National Institute of Metrology, Quality and Technology), is required. If certification is necessary, an entity called Organismo Certificador de Produto - OCP (Product Certification Body) must be hired, and the product(s) must be sent to the company based in Brazil that will act as the official party responsible for the registration process (the registration host, importer, and/or distributor), like WeRegister. This company will then forward the product(s) for testing at the certified laboratories.
In addition to product testing, the manufacturing company must also be inspected by the OCP. The INMETRO certification process takes 4 to 9 months, depending on the type of product, factory locality and the complexity of the tests.
1. Risk Classes I and II — Notification
For products in Classes I and II, the registration process is called Notification.
- Requirements: Neither certification of the foreign company nor prior product testing outside of Brazil are required.
- Approval time: The average approval time is 2 to 11 months, counted from the submission of the application to ANVISA, depending on the need for INMETRO certification.
2. Risk Classes III and IV — Registration
For products in Classes III and IV, the process is called Registration.
- Requirements: obtaining, before submission, the International Good Manufacturing Practices Certification from ANVISA.
This certification can currently be obtained in two ways:
A. Manufacturer has the MDSAP certificate (Medical Device Single Audit Program)
- Approval time: The International GMP Certification is approved in 1 to 2 months, without the need for an ANVISA audit at the foreign factory. After submission of the International GMP, the products can be submitted for registration.
B. Manufacturer does not have the MDSAP certificate
- Approval time: The International GMP Certification is approved in 9 to 15 months, depending on the product. ANVISA will perform an on-site inspection at the manufacturing plant.
Requests for registration of Class III and IV products may be filed before the International GMP Certification is concluded, provided they include proof of the application protocol and process number for the certification request. However, the registration analysis will only begin after the International GMP Certification is approved.
C. Registration Analysis after GMP and INMETRO certifications
- Requests for registration of Class III and IV products may be filed before the required certifications are concluded, provided they include proof of the application protocol and process number for the certification request. However, the registration analysis will only begin after the required certifications are approved.
The current regulation is the Resolução da Diretoria Colegiada - RDC (Collegiate Board Resolution) No. 665, dated March 30, 2022, published in the Diário Oficial da União (Official Gazette) No. 62, on March 31, 2022.
It establishes the Good Manufacturing Practices for Medical Devices (MD) and In Vitro Diagnostic (IVD) Products.
No product, reagent, or equipment intended for in vitro diagnostic (IVD) use requires INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia - National Institute of Metrology, Quality and Technology) certification.
Some medical devices (MD), however, do require INMETRO certification. Examples include:
- Sterile single-use hypodermic needles and sterile single-use dental needles;
- Equipment subject to health surveillance requirements;
- Single-use transfusion sets, gravity infusion sets, and infusion sets for use with infusion pumps;
- Pacifiers;
- Breast implants;
- Baby bottles and bottle nipples;
- Male condoms;
- Sterile single-use hypodermic syringes.
No product classified as Medical Devices (MD), Medical Materials or Medical Equipment require INCQS (Instituto Nacional de Controle de Qualidade em Saúde - National Institute of Quality Control in Health) certification.
Only in vitro diagnostic (IVD) products require INCQS certification, such as tests for Dengue, Chikungunya, SARS-CoV-2 (self-tests), and those intended for screening tests in blood banks: reagents for immunohematology (ABO system, Rh system, and irregular antibodies), Hepatitis B and C, Syphilis, HIV, Chagas disease, and HTLV.
The fees for notification, registration, inspection etc., vary according to the size of the company that will hold the registration in Brazil. WeRegister is classified as an EPP (Empresa de Pequeno Porte - Small Business).