Approval of medical devices in Brazil - A guide for manufacturers
Brazil is the largest medical technology market in South America and is subject to strict regulatory requirements. Manufacturers who wish to sell their products in Brazil must meet the specific requirements of the Brazilian health authority Agência Nacional de Vigilância Sanitária (ANVISA).
This guide provides a comprehensive overview of the regulatory requirements and the necessary steps for market access in Brazil.
General overview of the medical device market in Brazil
Population size
Brazil has a population of around 214 million people, making it the largest market for medical technology in Latin America.
Market volume
- The Brazilian market for medical products is estimated at around 10 billion US dollars.
- Brazil is heavily dependent on imports, particularly for high-tech medical products.
- The most important importing countries are the USA, Germany and China.
Forecasts for the next three years
- The market for medical technology in Brazil is growing at an estimated annual growth rate (CAGR) of 5 to 7 percent.
- The drivers of this growth include increasing investment in the healthcare system, the digitalization of the healthcare industry and the ageing population.
- The Brazilian government plans to further modernize the regulatory processes in order to facilitate foreign investment in the healthcare sector.
Competent authority for medical devices in Brazil
The Agência Nacional de Vigilância Sanitária (ANVISA) is the authority responsible for the regulation of medical devices in Brazil.
Tasks of ANVISA
- Registration and certification of medical devices
- Market surveillance and quality assurance
- Regulation of clinical trials for medical devices
- Checking compliance with Brazilian regulations for medical technology
Official source of information
Further information on the regulation of medical devices in Brazil is available on the official ANVISA website:
ANVISA - Agência Nacional de Vigilância Sanitária
Legal requirements in the destination country
Legal basis for medical devices in Brazil
The most important regulatory requirements for medical devices in Brazil are based on the following regulations:
- RDC 185/2001 - regulates the classification and registration of medical devices
- RDC 40/2015 - defines requirements for import and distribution
- RDC 16/2013 - complies with the international standard ISO 13485 for quality management systems
- RDC 36/2015 - defines requirements for conformity assessment
Brazil has adapted its regulatory system to international standards, in particular ISO 13485 and the requirements of the International Medical Device Regulators Forum (IMDRF).
Information on the need for a local representative
Is a local representative required to approve or register medical devices?
Yes, foreign manufacturers must appoint a Brazilian Registration Holder (BRH) to register their products in Brazil.
Requirements for the Brazilian Registration Holder (BRH)
- The BRH must be a company based in Brazil.
- The BRH is responsible for registration and compliance with all regulatory requirements vis-à-vis ANVISA.
- The BRH handles communication with ANVISA and provides support with vigilance and reporting obligations.
A manufacturer can appoint several BRHs for different product lines. However, it is advisable to choose a trustworthy partner, as the BRH has control over the registration.
Definition and classification of medical devices
According to which law is this determined in Brazil?
Medical devices are classified in accordance with ANVISA Resolution RDC 185/2001.
Classification of medical devices according to ANVISA
Medical devices in Brazil are divided into four risk classes, similar to the EU regulations:
- Class I - Low risk (e.g. dressings, surgical scissors)
- Class II - Medium risk (e.g. ultrasound devices, infusion pumps)
- Class III - Higher risk (e.g. dialysis machines, ventilators)
- Class IV - High risk (e.g. pacemakers, implants)
In vitro diagnostics (IVDs) are also divided into four risk classes.
Approval process for medical devices in Brazil
What approval procedures are there?
ANVISA distinguishes between two main procedures for the approval of medical devices:
- Cadastro process (for class I and II products)
- Simplified registration procedure
- Submission of a technical file with basic product information
- Registro procedure (for class III and IV products)
- Detailed technical documentation required
- Conformity assessment by a body accredited by ANVISA
Average duration of approval procedures
- Cadastro process: approx. 3 to 6 months
- Registro process: approx. 12 to 24 months
The processing time depends heavily on the quality of the documents submitted and ANVISA's workload.
Costs incurred
The costs for registration vary depending on the product class:
- Cadastro procedure: approx. 5,000 to 10,000 BRL
- Registro procedure: approx. 15,000 to 30,000 BRL
Additional costs are incurred for translations, local audits and quality management certifications.
Validity of the registration or approval
- Cadastro registrations are valid indefinitely as long as no changes are made to the product.
- Registro approvals must be renewed every five years.
Language requirement
- All documents must be submitted in Portuguese.
- Product labels, instructions for use and packaging must be available in Portuguese.
Conclusion
The approval of medical devices in Brazil requires comprehensive preparation and compliance with strict regulatory requirements. In addition to registration with ANVISA, a Brazilian Registration Holder (BRH) is required to act as a local representative.
Important points summarized:
- Brazilian Registration Holder (BRH) is mandatory for foreign manufacturers.
- ANVISA distinguishes between Cadastro and Registro procedures.
- The processing time varies between 3 months and 2 years.
- All documents must be submitted in Portuguese.
Support from MEDAGENT
MEDAGENT offers comprehensive services for market access in Brazil:
- Assumption of the function of Brazilian Registration Holder (BRH)
- Support with registration and compliance with ANVISA requirements
- Advice on quality management systems in accordance with ISO 13485
- Direct communication with ANVISA to optimize the approval process
For more information or assistance with the approval of medical devices in Brazil, please contact us directly.
