
Overview:
Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context.
Introduction:
Medical devices play a crucial role in promoting health, providing a diverse range of solutions for diagnosing, treating and monitoring medical conditions. Understanding the variety of medical devices available is key to properly selecting the options best suited to each patient’s individual health needs. In this context, we investigated the main types of medical devices and their specific applications in the Brazilian context.
Types of Medical Devices: :
Medical Device: Any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article intended to be used in human beings for various specific medical purposes.
Active Medical Device: Depends on an external energy source to function and can change density or convert energy to operate. Excludes devices that only transmit energy or substances without significant alteration.
Active Medical Device for Diagnosis and Monitoring: Provides information for the detection, diagnosis, monitoring, observation or treatment of physiological states, health, diseases or congenital malformations.
Active Therapeutic Medical Device: Used to maintain, modify, replace or restore biological functions or structures during the treatment or alleviation of a medical condition.
Single-Use Medical Device: Intended for use in a single procedure, as specified by the manufacturer.
Implantable Medical Device: Introduced fully or partially into the human body and intended to remain in place after clinical intervention for a defined period.
Invasive Medical Device: Partially or totally penetrates the body, either through natural orifices or by crossing the body surface.
In Vitro Diagnostic Medical Device: Used to analyse samples derived from the human body, providing information for diagnosis, monitoring, prognosis and other purposes.
Conclusion
Understanding these definitions is crucial to ensuring the proper and safe use of medical devices in clinical practice.
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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.