Overview

Brazil is one of the biggest countries in South America and Latin America. It spends hugely on healthcare boosting the Medical Devices locally. The country has established regulations in place and it governs Medical Devices through National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) under Ministry of Health. The registration is done through Cadastro or Registro processes basing on the device classification (Class I, II, III and IV) which also decides the extent of scrutiny involved for approval. Further, all the medical device manufacturers need to comply with Brazilian Good Manufacturing Process (BGMP) which is in lines with ISO 13485. The complex, stringent and extensive Regulatory regime makes the process daunting.

Freyr assists manufacturers to identify the Device Classification as a first step. Freyr helps clients in procuring certifications such as INMETRO and BGMP by helping in rectifying the Regulatory hassles involved. With proven expertise in launching numerous devices in the region, we offer end-to-end Regulatory services for Medical Devices.

Freyr Expertise

  • Medical Device Classification
  • Brazil Local Representation
  • Regulatory Support to acquire Brazilian Good Manufacturing Process (BGMP) Certification
  • Support for Procuring INMETRO Certification
  • Document Compilation for Cadastro and Registro Processes
  • Post-market Surveillance

Brazil Market Entry for Medical Devices - Process Flow

Vietnam Medical Device Regulations

Summary

S. No

Requirement

Brazil

1

Regulatory Authority

Agência Nacional de Vigilância Sanitária
(ANVISA)

2

Regulation

RDC 185/2001

3

Risk Classification

Class I

Class II

Class III

Class IV

4

Regulatory Pathway

Class I & II

Cadastro

 

 

Class III & IV

Registro

5

Authorized Representative

Authorized Representative required

6

Fee payable

$1000 - $12,500*

7

QMS Requirement

Brazilian GMP / MDSAP

8

Assessment of Technical Data

ANVISA

9

Validity of License

Cadastro

Perpetual

 

 

Registro

5 Years

10

Labelling Requirements

Annex III.B of RDC 185/2001

11

Submission format

Paper & Electronic

12

Final Outcome

Registration number in DOU

13

Timelines

Cadastro

1 - 3 Months

Registro

9 - 15 Months

14

Language

Brazilian Portuguese/English

*The price is as per records at the time of documentation and is subject to change.