Brazil ANVISA Regulatory Approval Process for IVDs

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Manufacturers need to obtain ANVISA (​Agência Nacional de Vigilância Sanitária) approval prior to selling their products in Brazil. Brazil has four classes of IVDs with ascending risk, and multiple registration pathways. Cadastro and Registro. The Cadastro registration route is for lower-risk IVDs, has a simplified application, and typically takes less time than Registro reviews. Recently the Notificação pathway was created for Class I low-risk IVDs, allowing circumvention of the registration and approval process for faster market access. Download the chart in PDF, or read below for the explanation of the process. 

The Brazilian (ANVISA) In Vitro Diagnostic (IVD) approval process explained

Step 1
Determine classification of your In-Vitro Diagnostic device (IVD) using rules found in Chapter II of Brazilian Resolution RDC 36/2015 published by ANVISA (Agência Nacional de Vigilância Sanitária). Class I IVDs are subject to a notification to ANVISA.* Class II-IV IVDs are subject to ANVISA review prior to approval. Class II IVDs are registered via the Cadastro route, while Class II and IV IVDs are registered via the more complex Registro route.

Step 2
For all classes: Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).

Step 3
For all classes: Provide Letter of Authorization to your BRH, who will submit your registration application to ANVISA. Your BRH maintains control of your IVD registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable.

Step 4
Class I and II IVD manufacturers must comply with BGMP requirements as found in RDC 16/2013. ANVISA will not conduct an inspection.

Class III and IVD manufacturers must be audited for BGMP compliance by ANVISA as outlined in RDC 16/2013. BGMP fees are due every two years.

Step 5
For all classes: Prepare Technical Dossier (TD) conforming to Chapter IV of RDC 36/2015, including a description of the IVD, images, risk management files, a list of technical standards adopted, stability studies, manufacturing process information and IVD labeling (IFU and labels) compliant with Chapter V of RDC 36/2015.

Step 6
Class I IVD (Notificação): The TD is not submitted with the notification petition but must be maintained on-site by your BRH.

Class II IVD (Cadastro): The TD must be submitted with the registration petition and include performance study reports.

Class III and IV IVD (Registro): The TD must be submitted with the registration petition and include performance study reports plus clinical evidence reports.**

Step 7
For all classes: Your BRH prepares and submits the application to ANVISA. All documents must be submitted in Brazilian Portuguese. Pay application fee.

Step 8

Class I IVD: Upon complete submission of required documents, ANVISA issues notification number.

Class II-IV IVD: ANVISA reviews registration application. Upon approval, ANVISA will publish registration number in the Diário Oficial da União (DOU).

Step 9
Class I notifications and Class II registrations do not expire.

Class III and IV registrations are valid for 10 years. Registration renewals must be initiated one year, and no later than six months, prior to expiration.

Step 10
For all classes: Appoint a qualified importer/distributor to bring your device into Brazil. You may now begin marketing your IVD.

NOTE: Some IVDs listed in RDC 3385/2006 require an Economic Information Report (EIR) compliant with RDC 185/2006 be submitted to NUREM, a division of ANVISA, with the application or within 30 days after its approval. This report includes pricing comparisons for other markets, patient/user information, and marketing materials.

*ANVISA issues a notification number for Class I IVDs upon complete submission of the application materials; ANVISA does not perform a technical review. However, ANVISA may cancel a notification due to lack of proper documentation, post-market issues, or an incorrect classification.

** Some Class IV IVDs are subject to prior analysis by INCQS (National Institute of Quality Control in Health) and analysis test results must also be presented as part of the submission. There are specific requirements for the number of lots and sample sizes that must be tested for such products.

This is a simplified overview of the process. ANVISA may choose to audit your submission and request more documents, which will add time to your approval.

Table updated 07/2019.

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