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Deviceology - The Brazil Market Access People

Deviceology is uniquely positioned to assist clients in navigating the complexities of the Brazilian Medical Devices market. Leveraging our extensive expertise in international regulations and ISO standards, such as ISO 13485 for quality management and RDC 16/2013 for Good Manufacturing Practices (GMP), we offer a comprehensive suite of services that facilitate market entry.

Our team provides invaluable guidance on regulatory compliance, ensuring that your medical devices meet the stringent requirements set forth by the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil. We also offer insights into the Medical Device Single Audit Program (MDSAP), enabling manufacturers from the U.S., EU, and other MDSAP-recognised countries to use regulatory clearance information for a smoother approval process in Brazil.


Moreover, Deviceology understands the market dynamics and consumer demands in Brazil, which is crucial for successful market penetration. We offer market research services that identify potential gaps in the market, as well as areas of growth—such as cardiology and orthopedic devices, which are seeing increased demand due to Brazil's diverse and growing population.

Our end-to-end solutions, from market research to market launch, are designed to not only meet regulatory and international standards but also to align with Brazil's healthcare policies and expenditure patterns. This includes compliance with INMETRO regulations for medical devices, as well as understanding the intricacies of the Brazilian Unified Health System (SUS).

By partnering with Deviceology, clients can expect a streamlined, compliant, and strategic entry into the lucrative Brazilian Medical Devices market.

Market Data

Medical Devices Market Valuation

2023: projected to reach a valuation of US$8.39 billion

2028: projected to reach a valuation of US$13.04 billion

Annual growth rate (CAGR) of 9.22%

Market Segmentation

The largest segment in the Brazil Medical Devices market is Cardiology Devices, with a projected market volume of US$1.21 billion in 2023.

  • Connected Healthcare Devices: Focus on IoT and mobile applications for healthcare.

  • Low-Tech Medical Devices: High demand due to cost-conscious market.

  • Lifestyle Medical Market: Includes aesthetic plastic surgeries and non-surgical aesthetic procedures.

  • Public Healthcare System (SUS) Supply: Government as the main buyer for public healthcare.

  • Productive Development Partnerships (PDPs): International companies partnering with local labs for technology transfer.


Market Dynamics

The Brazil medical devices market is experiencing growth due to several factors. These include the increasing prevalence of chronic diseases, rising healthcare expenditure, and advancements in medical technology. The market is also propelled by favorable government initiatives and a growing aging population.

Emerging opportunities in the market include the increasing demand for minimally invasive procedures, expansion of the private healthcare sector, and the adoption of telemedicine. There is also a growing focus on personalized medicine, which could lead to significant market growth.

Contact us to discuss your access requirements for the Brazil's Medical Device market

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