Brazil's ANVISA (National Health Surveillance Agency) classifies medical devices into different categories based on their nature and use. The following are general classifications of medical devices, which may be defined in more detail in Anvisa's regulations and guidelines:
Category I - Impenetrable Devices:This includes some basic medical devices that are not normally in direct contact with the human body, such as operating room equipment.
Category II - Penetrable Devices:This includes medical devices that need to penetrate the body's surface, such as syringes, catheters, etc.
Category III - Implants:Medical devices that involve implantation or interaction with the inside of the human body, such as pacemakers, joint prostheses, etc.
Category IV - Diagnostics:Medical devices used in medical diagnostics, including X-ray equipment, pathology and clinical laboratory equipment, etc.
Category V - Medical Monitoring Equipment:This includes devices used to monitor the patient's physiological condition, such as an ECG machine, blood pressure monitor, etc.
Category VI - Clinical**Device:Equipment involving medical equipment, such as surgical equipment, equipment, etc.
Category VII - Health Care Devices:Including some health care products such as toothbrushes, oral care products, etc.
Category VIII - Functional Assistive Devices:Assistive devices that assist in human body functions, such as hearing aids, wheelchairs, etc.
This is only a general classification, and the specific classification criteria and definitions may vary depending on the characteristics and use of the medical device. If you need to know the specific classification requirements for a specific product, it is recommended to consult the regulatory documents of Anvisa Brazil directly or contact the relevant department of Anvisa. Anvisa typically provides detailed guidelines and classification information to help manufacturers and importers properly classify their medical devices.