Brazil Medical Device Registration

Navigating ANVISA Regulations in Brazil: Comprehensive Guide for Medical Device Manufacturers

Regulatory Authority

Anvisa

The Brazilian Health Regulatory Agency (Anvisa) is a government agency that coordinates the Brazilian Health Regulatory System (SNVS) across the country. Its role is to protect the health of the population by regulating the production, marketing, and use of health-regulated products and services.

The agency also controls ports, airports, and borders. Its mission is to intervene in risks associated with these products and services within the National Health System.

Its vision is to be recognized nationally and internationally for its efforts in health promotion, citizenship, and development, operating efficiently and transparently, and demonstrating its leadership in regulation and health control.

Link for Regulatory Authority

https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao

Local Regulation

RESOLUTION – RDC No. 102, OF AUGUST 24, 2016

Classification of Medical Devices

Class I, II, III, IV

Registration for Class I and II

Follow the Notification route, which includes a simplified application and requires no review by ANVISA
Brazilian Registration Holder (BRH) is necessary for Notification
Submit an application and the required documents to ANVISA
Manufacturers must support and share a complete technical dossier for their Brazilian Registration Holder
A BRH must always keep on file, along with the Brazilian dossier, labelling and IFUs, in case of an on-site inspection by ANVISA
Class I and II registrations do not expire

Registration for Class III and IV

Follow the registration process
Brazilian Registration Holder (BRH) is necessary for Registration
Manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional information about the devices, supported by expert medical device technical documentation preparation.
A BRH must always keep on file, along with the Brazilian dossier, Legal Documents, labelling and IFUs, in case of an on-site inspection by ANVISA
Class III and IV registrations expire after 10 years

Documents Required for Registration

Ordinary registration (registro): Prepare application documents including general device information, certificate of free sale, GMP, instruction manual, labeling, clinical data, clinical studies (if applicable).
Abbreviated registration (cadastro): prepare technical dossier including legal documents and labeling information.

Registration Timeline

Class I and II Devices:1-3 months
Class III and IV devices: 3-4 years. This is due to the GMP certification process, verified through a thorough GMP compliance audit.

License Validity

Class I and II: Indefinite
Class III and IV:5 years

License Renewal

May be initiated as early as one year before device registration expires, and no later than six months.

Special Labelling Requirements

All documents must be translated into Portuguese.

Additional Comments

All foreign manufacturers must appoint a local Brazil Registration Holder (BRH) to act as their legal representative in Brazil.

Submitting adverse events related to Medical Devices to ANVISA

Outlined below are the fundamental steps to be followed when reporting an adverse event in Brazil:

Refer to Resolution RDC No. 67/2009 and Resolution RDC No. 551/2021 to determine the appropriate reporting timeline, which is contingent upon the severity of the incident.
Notify both your Brazil Registration Holder and the National Sanitary Surveillance System (SNVS) about the occurrence of a reportable adverse event.
Inform your Registration Holder and ANVISA if a field safety action is deemed necessary. Comply with the specified timeline depending on the nature of the event when notifying ANVISA.
Disseminate an alert message to consumers when implementing the field safety action. Submit monitoring reports and final adverse event reports to both SNVS and ANVISA.
Incorporate all reports into ISO 13485 or other quality system records, integrating proper pharmacovigilance monitoring frameworks.

In Brazil, when is it necessary to submit medical device vigilance reports

An adverse event should be reported in the following situations related to device malfunction or misuse:

Death or serious injury has occurred.
There is a potential for death or serious injury if the event were to happen again.
Other applicable circumstances, as stipulated in the regulations.

Both as the device manufacturer and in collaboration with your Brazil Registration Holder (BRH), you bear the responsibility of reporting adverse events to the National Sanitary Surveillance System (SNVS). Additionally, under specific conditions, a Technical Complaint must be reported if a recurrence could lead to a severe adverse event.

In cases where a field safety action or recall is deemed necessary to mitigate the risk of death or serious injury, manufacturers must promptly notify ANVISA. Simultaneously, an alert outlining the required corrective action must be reported to ANVISA and distributed to consumers.

Who should make this Communication?

Manufacturer
Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

Act as your Authorized representative

Why Choose Us?

Working towards client satisfaction
Cost effective solutions
Project completion before deadline
Quality Regulatory affairs solutions

https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/produtos-para-a-saude

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Frequently Asked Questions

1. What Is ANVISA in Brazil?

ANVISA (Brazilian Health Regulatory Agency) is the national authority responsible for regulating medical devices and other health-related products in Brazil. It oversees medical device notification, registration, and applicable safety and quality requirements.

2. How Do You Register a Medical Device in Brazil?

Medical device registration in Brazil involves identifying the device's risk classification, appointing a Brazilian Registration Holder, preparing the required technical documentation, and submitting the applicable notification or registration application to ANVISA. The process depends on the device type and regulatory requirements.

3. What Are the Risk Classes for Medical Devices in Brazil?

ANVISA classifies medical devices into four risk classes: Class I (low risk), Class II (medium risk), Class III (high risk), and Class IV (maximum risk). Class I and II devices generally follow the notification pathway, while Class III and IV devices generally require registration.

4. What Documents Are Required for Medical Device Registration in Brazil?

The required documents depend on the device classification and submission route. They may include manufacturer information, technical documentation, a manufacturer authorisation letter, a Certificate of Free Sale where applicable, labelling, instructions for use, and relevant quality or Good Manufacturing Practices documentation.

5. Is a Brazilian Registration Holder Required for Foreign Medical Device Manufacturers?

Yes. Foreign medical device manufacturers generally need a company legally established in Brazil to act as the local applicant and, where applicable, the notification or registration holder. This entity is responsible for applicable regulatory obligations associated with the device in Brazil.