Medical Devices Regulatory Support in Brazil

Overview

Brazil is one of the fastest-growing markets for Medical Devices in the world. Brazil spends a lot on healthcare to boost the development of Medical Devices locally. It has established regulations in place and governs Medical Devices through National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) under the Ministry of Health. ANVISA follows strict regulations for Medical Device Registration in Brazil.

Regulation: RDC 423/2020 amendment of RDC 185/2001

Regulatory Pathway: Notification (Notificação) and Registration (Registro)

Authorized Representative: Brazil Registration Holder (BRH) Required

QMS Requirement: Brazilian GMP/MDSAP

Assessment of Technical Data: ANVISA

Labeling Requirements: Annex III.B of RDC 185/2001

Submission Format:  Electronic

Language: Brazilian Portuguese/English

Classification of Medical Devices

Brazil Medical Device Classification is divided into the following classes based on the risk level.

Medical Device Class

Criteria

Class I

Low Risk

Class II

Medium Risk

Class III

High Risk

Class IV

Maximum Risk


Registration of Medical Devices

Market Authorizations

 In the ANVISA Regulatory process, the first step in determining the registration path and compliance with Brazilian regulations is to ascertain the Brazil Medical Device Classification. Market authorizations are issued by the ANVISA depending on the risk classification of the medical device. Market authorizations for products for Risk Class I and Class II do not expire, but they might be cancelled upon request, in case of reassessment, inability of solving irregularities, or when fraud is observed.

From the Brazil Medical Device Classification, the pre-market approvals for products categorized as Risk Class III and IV are valid for ten (10) years from the date of their publication in the Brazilian Official Gazette and may be renewed for equal and successive periods.

Foreign companies should have partner companies legally constituted in Brazil to make administrative arrangements for obtaining market authorizations from ANVISA. This local agent will be legally responsible for the products imported and distributed in the Brazilian territory.

Medical Devices Notification (For products Categorized as Risk Class I and II)

 From the Brazil Medical Device classification, product categorized as Risk class I and II must be notified to ANVISA by the manufacturing or importing company established in Brazil. It is necessary to submit a notification to ANVISA with all the information requested according to the current requirements. Notification products are subjected to the sample analysis and in case of incomplete dossier, the approval is not granted.

 It is not necessary to wait for ANVISA´s approval to place the product on the market.

Medical Devices Registration (For products Categorized as Risk Class III and IV)

In Brazil,  devices are categorized as Risk class III and IV and the applications must be submitted to ANVISA by the manufacturing or importing company established in Brazil. These products will be analyzed by the ANVISA before granting an approval.

It is necessary to wait for ANVISA´s approval to place devices on the market.

Product Maintenance & Compliance

Sl. No

Validity of Registration Certificate

Renewal

Post-approval Changes (Variations)

01

Ten (10) years

The renewal application must be submitted six (6) months before expiration of the existing registration certificate, along with documents mentioned in the current regulation. For the products submitted to notification process, renewal application is not necessary.

Any change in notified or registered medical devices must be sent to ANVISA with relevant documents according to the current requirements.

Freyr Expertise

  • End-to-end Product Registration
  • Strategic Regulatory Guidance during Product Development & Regulatory Affairs Support
  • Carrying Out Gap Analysis, Reviewing & Submitting the Dossier to the ANVISA
  • Interpreting Regulations and Developing the Regulatory Documentation
  • Representing as RA CMC in Health Authority Meetings
  • Interacting with the ANVISA
  • Strategically Handling the HA Queries and Preparing Response Packages
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