Medical Device Registration and Approval in Brazil

General country-specific regulatory information is provided on this page for medical device registration and approval in Brazil. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Brazil, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in Brazil

REGULATORY AUTHORITY: Medical devices are regulated by ANVISA (Agência Nacional de Vigilância Sanitária, or the Health Surveillance Agency)

CLASSIFICATION SYSTEM: Devices are classified according to a risk based model.

Medical Devices: Medical Devices are classified into four classes based on risk (Class I-IV).

IVD Devices: IVD Devices are classified into four classes based on risk (Class I-IV)

TIMEFRAME: There are two different pathways for registration: cadastro for Class I and II devices and registro for Class III and IV devices. Approval takes only 4-6 months for the cadastro process. For the registro process, an ANVISA audit is required, after which registration takes an additional 8-10 months.

SPECIAL REQUIREMENTS:

Audits: A GMP audit is mandatory for manufacturers of class III and IV devices, based on the Brazilian GMP regulations.

Technical Local Tests: Local certification requirements may apply to the device, such as ANATEL (for wireless devices) or INMETRO certification.

Clinical Evaluation/studies: Specific clinical evaluation or studies may be requested to prove safety and efficacy of the products for high class devices or Innovative health products (regardless of their risk class). In these cases, a clinical assessment report must be submitted at the time of application for registro or cadastro, contemplating clinical trial(s) that provides valid and sufficient scientific evidence for verification and confirmation of the safety and effectiveness of the target product of submission.

LOCAL FEES:

Application review fees: The fees depend on the size of the Brazilian LH and the risk class of the device.

Manufacturer registration: Approximately $20 000 – $30 000 USD.

LICENSE VALIDITY: Cadastro licenses issued in Brazil (for class I and class II devices) don’t expire, Registro licenses are valid for 10 years.

LICENSE TRANSFER: License transfers are possible and allowed in Brazil.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required to register medical devices in Brazil. The representative must be a local company authorized by ANVISA.

ADDITIONAL INFORMATION: 

There has been an update in the regulations through RDC 270/2019, which establishes a notification pathway for Class I medical devices and IVDs. This new regulation further simplifies the Cadastro registration process and it allows manufacturers to access the Brazilian market much quicker. This notification pathway will go into effect in May, 2019.

The new pathway wont change the list of required documentation for Class I medical devices who are on the Cadastro registration route, instead these will be reported to ANVISA so that notification numbers may be issued. Manufacturers may begin marketing their devices in Brazil after receiving notification numbers and including them on the label of the device. The issuance of notification numbers is not expected to take more than 30 days after the submission date.

Last updated on March 28, 2019.

 

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