Agency
All medical devices are regulated by the The Brazilian National Health Surveillance Agency (ANVISA)
Medical Device Definition
A medical device is a healthcare product, such as equipment, devices, materials, articles,or systems for medical, odontological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological, immunological, or metabolic means to fulfil its main function in human beings, but have its functions assisted by such means. RDC 185/2001, Annex I.
Classification of Medical Device
Classification | Examples | Risk Level |
Class I | Simple surgical instruments, tongue depressor | Low |
Class II | Digestive catheters, infusion pumps, and powered wheelchairs | Low-Moderate |
Class III | Dialyzers, and orthopaedic implants | High-Moderate |
Class IV | Coronary stents | High |