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The devices’ high cost which includes a comparatively higher acquisition cost, and subsequent maintenance costs, leads to an overall increased device cost and ownership. Some of the advanced healthcare devices are associated with various other components such as chips, batteries, sensors, and some other accessories which require periodic replacement.
Electrical medical devices and some non-electrical medical devices can be registered at ANVISA, they must successfully achieve INMETRO certification through an INMETRO accredited certification body. A factory inspection prior to INMETRO certification is also required. In order to maintain the INMETRO certification, annual factory inspections have to be carried out.
The medical device manufacturing companies in Brazil are largely focusing on high end technology driven products. Moreover, with the prevalence of lifestyle diseases such as diabetes, stroke and chronic diseases such as HIV, Tuberculosis, the hospitals and specialized clinics require advanced and priority medical devices.
The demand of medical devices is growing majorly in the cities of Southeast region such as Sao Paulo and Rio de Janeiro largely due to the strong infrastructure support for the installation and accessibility of these medical devices.
The Brazilian medical segment is focused on areas that include technological innovations such as the practice of telemedicine, the application of artificial intelligence in diagnosis and the digitization of the patient’s health history.
The use of artificial intelligence is one of the major trends which have positively impacted the medical device industry of the country. World Bank study shows that the use of the application of Artificial Intelligence to the analysis of electronic medical records could save BRL 22 Bn by avoiding unnecessary repetition of tests and treatments in Brazil.
Use of artificial intelligence improves turnaround time for patient testing and using predictive analytics on the basis of historical patient data can improve clinical outcome.
Medical equipment is a device, instrument, apparatus, appliance, software, or material. It can be used as a combination or alone. Its intended action is not achieved by pharmacological, immunological, or metabolic means. By making this equipment, we give people longer, better, and healthier lives.
This equipment holds risk on using it. Therefore, every medical equipment is subdivided into hazard classes. Class I being the lowest risk such as tongue depressors, disposable gloves, and type III being the highest risk such as pacemakers, artificial heart valves. The general rule to classify the devices is the amount of testing that is required to establish safety and efficacy. The criteria for the classes can change from country to country.
All medical devices in classes III and IV (comparable to classes IIb and III in accordance with 93/42/EEC) are subjected to Brazilian GMP (BGMP) inspections carried out by ANVISA in two-year intervals. Alternatively, manufacturers can participate in the Medical Device Single Audit Program (MDSAP). For medical device registration at ANVISA, an audit report based on MDSAP would also be accepted.
Building on the clustering approach and identification of market specifics, the Brazilian healthcare industry represents an attractive market, with increasing potential, for medical device companies.
The Medical equipment market has been on the rise in Brazil for the past few years now and will only continue to do so. Technology is developing rapidly and has a positive influence on the medical market, helping the people in need.
Brazil has Latin America’s biggest economy and the biggest market for medical devices. Only a minor portion of the Brazilian market is made up of imports. Domestic producers prioritize satisfying domestic demand, and as a result, exports are likewise infrequent.
The Brazil Medical Devices Market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
Adoption of Minimally Invasive Procedures
Increased awareness of the benefits of minimally invasive procedures (MIPs) has driven their adoption across various specialties, including cardiology, orthopedics, and gynecology.MIPs offer shorter recovery times, reduced pain, and fewer complications compared to traditional open surgery.This trend has grown the demand for specialized medical devices designed for MIPs.
Increasing Focus on Digital Health and Telemedicine
Digital health solutions has gained traction in Brazil, offering improved access to healthcare for patients in underserved areas and remote locations.Telemedicine consultations, remote monitoring systems, and mobile health applications has increased the use for diagnosis, treatment, and patient management.This trend has grown the development and adoption of connected medical devices and data-driven healthcare solutions.
Rising Demand for Personalized Medicine
The increased understanding of individual genetic variations and disease predispositions has drove the adoption of personalized medicine in Brazil.This requires advanced diagnostic tools and targeted therapies for specific patient needs.The medical devices market is responding to this trend by developing innovative solutions for personalized medicine, including precision diagnostics and companion diagnostics.
Investments in Artificial Intelligence (AI)
AI is gained significant traction in the medical devices market, with applications in image analysis, diagnostics, robotic surgery, and drug discovery.AI-powered solutions are expected to improve diagnostic accuracy, personalize treatment plans, and enhance surgical precision.The adoption of AI in the medical devices market is still in its early stages, but it has the potential to revolutionize healthcare delivery in Brazil.
Philips – Lumify AI-powered Ultrasound System: This portable ultrasound system utilizes AI algorithms to assist clinicians in image acquisition, analysis, and reporting. It offers improved diagnostic accuracy and workflow efficiency, particularly in resource-limited settings.
GE Healthcare – Allia IGS 750 Digital X-ray System: This digital X-ray system provides advanced imaging capabilities with a lower radiation dose compared to traditional systems. It also features AI-powered tools for image optimization and automated reporting.
Siemens Healthineers – Atellica CH 930 Immunoassay Analyzer: This high-throughput immunoassay analyzer offers rapid and accurate results for a wide range of clinical tests, including cardiac, infectious diseases, and tumor markers. It is designed to improve laboratory efficiency and patient management.
Medtronic – InPen Smart Insulin Pen: This smart insulin pen connects to a mobile app, allowing users to track their insulin doses, monitor blood glucose levels, and receive personalized insights. It helps patients with diabetes manage their condition more effectively.
Abbott – MitraClip System: This minimally invasive device treats mitral valve regurgitation, a common heart valve condition. The MitraClip system offers a less invasive alternative to open-heart surgery for certain patients.