Brazil Medical Device Regulations

Medical Device Definition

Medical Device (Medical Product): Any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material, or another article, intended by the manufacturer to be used, alone or combined, in human beings, for any of the following specific medical purposes, and whose main action intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action by such means:

• diagnosis, prevention, monitoring, treatment (or alleviation) of a disease);
• diagnosis, monitoring, treatment, or repair of an injury or impairment;
• investigation, replacement, or alteration of the anatomy or of a physiological or pathological process or state;
• support or maintenance of life;
• control or support of conception; or
• provision of information through in vitro examination of samples from the human body, including organ and tissue donations.

Active Medical Device: any device whose operation depends on a source of energy not generated by the human body for that purpose, or by gravity, and which acts by changing the density or by converting that energy, except those intended to transmit energy, substances or other elements between an active device and the patient without producing any significant change.

Active Medical Device for Diagnosis and Monitoring: any active device used alone or in combination with other devices to provide information for the detection, diagnosis, monitoring, observation or treatment of physiological states, health conditions, diseases or congenital malformations.

Active Therapeutic Medical Device: any active device used alone or in combination with other devices to maintain, modify, replace or restore biological functions or structures in the context of a treatment or mitigation of a disease, injury or disability.

Single-Use Medical Device: a device intended to be used on one person during a single procedure, as specified by the manufacturer.

Family: grouping of medical devices, for the purpose of notification or registration, provided for in specific regulations, where each product has similar technical characteristics of:

1. Indication, purpose of use;
2. Functioning and action;
3. Technology;
4. Content or composition, when applicable; and
5. Precautions, restrictions, warnings and special care.

According to Art. 4 of the resolution RDC No. 751/2022.

Kit (set or tray): set of medical devices that, regardless of being registered or notified individually, are grouped in a sales unit for a specific purpose of use or procedure:

1. for regularization purposes, the set must be from the same manufacturer or manufacturing group; and
2. the components of a medical device kit, in isolation, do not maintain an interdependent relationship to obtain the intended functionality and performance.

System: set of compatible medical devices, which relate or interact with each other, exclusively with the aim of fulfilling a purpose intended by the manufacturer.

Medical Device Classification System

Note: All Medical Devices and In Vitro Diagnostics must be classified according to the 22 Risk Classification Rules.

Regulatory Approval Process

Additional Information