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
• 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

1. Ordinary registration (registro): Prepare application documents including general device information, certificate of free sale, GMP, instruction manual, labeling, clinical data, clinical studies (if applicable).
2. 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

Registration Fee

• Class I and II (Low risk): USD 190,00
• Class III and IV (High Risk): USD 890,00
• GMP Certification: USD 25.890,00

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.

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

Contact us for free consultation: info@omcmedical.co.uk

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