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Brazil ANVISA Regulatory Approval Process for Medical Devices

Medical device manufacturers need to obtain ANVISA (Agência Nacional de Vigilância Sanitária) approval prior to selling their products in Brazil.

Brazilian regulators update economic monitoring requirements for some medical devices

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Medical device manufacturers need to obtain ANVISA (Agência Nacional de Vigilância Sanitária) approval prior to selling their products in Brazil. Brazil has four classes of devices with ascending risk, and three registration pathways: NotificaçãoCadastro, and Registro. Download the chart in PDF, or read below for the explanation of the process

The Brazilian (ANVISA) medical device approval process explained

Step 1
Determine classification of your device using rules found in Annex II of Resolution RDC 185/2001 published by ANVISA (Agência Nacional de Vigilância Sanitária). Class I devices are subject to a notification to ANVISA.*
Class II-IV devices are subject to ANVISA review prior to approval. Class II devices are registered via the Cadastro route, while Class III and IV devices 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 device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable.

Step 4
For all classes: Certain devices** require INMETRO Certification. Testing for electro-medical products performed outside Brazil is usually accepted, if performed by an ILAC-certified lab.*** Compile tests and pay fee to INMETRO Certifier. INMETRO certification is valid for 5 years, and annual audits and fees are required. Additionally, certain devices require INCQS testing.

Step 5
For Class I (Notificação) and II (Cadastro): Class I and II device manufacturers must comply with BGMP requirements. However, ANVISA will not conduct an audit.

For Class III and IV (Registro): Class III and IV manufacturers must be audited for BGMP compliance by ANVISA as outlined in RDC 16/2013. BGMP fees are due every two years.

Step 6
For Class I (Notificação) and II (Cadastro): Prepare Technical Dossier application forms according to RDC 40/2015 requirements. Technical dossiers are not submitted to ANVISA but must be maintained by your BRH in case of ANVISA on-site inspections.

For Class III and IV (Registro): Prepare Technical File, including clinical data, clinical studies (if applicable), information on your device in accordance with Annex III, Part A, B, and C in RDC 185/2001, and proposed labeling (IFU and labels) per Annex III Part B.

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

Step 8
For Class I: Upon complete submission of required documents, ANVISA issues notification number.

For Classes II-IV: 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 device.

NOTE: Some devices 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 devices 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.
** Includes a variety of devices, such as breast implants, sterile hypodermic syringes, sterile needles, examination/surgical gloves, condoms, certain mattresses, blood bags, intrauterine devices, and those electromedical
devices outlined in IN 4/2015.
*** Third edition of IEC 60601 testing is mandatory. All tests performed outside of Brazil must be less than two years old or 4 years if large-sized equipment when they are submitted to INMETRO Certifier.

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 08/2019.

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