What is a Medical Device?
The legal definition
Under RDC 751/2022 and Lei 6.360/1976, a medical device (produto para saúde) in Brazil is defined as a product — instrument, apparatus, equipment, implant, reagent, software, material or similar article — intended by the manufacturer to be used, alone or in combination, in humans for one or more of the following purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for injury or disability;
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- Providing information by means of in vitro examination of specimens derived from the human body; and
- Control or support of conception.
The product must not achieve its principal intended action by pharmacological, immunological or metabolic means — if it does, it is classified as a drug (medicamento), not a device.
Intended purpose — the key principle
As in other major regulatory frameworks (EU MDR, FDA), Brazilian law places the intended purpose (finalidade prevista) at the centre of the definition. The intended purpose is determined by the manufacturer's labelling, instructions for use, and promotional materials.
ANVISA's intended purpose analysis is closely aligned with the IMDRF and EU MDR approach. Unlike the US FDA's "intended use" doctrine, Brazilian law does not distinguish labelling-based and promotion-based intent as separate legal categories — both are considered together.
Common examples by category
| Category | Examples |
|---|---|
| Diagnostic imaging | Ultrasound, X-ray equipment, MRI systems |
| In vitro diagnostics (IVDs) | Blood glucose meters, pregnancy tests, COVID-19 antigen tests |
| Therapeutic devices | Pacemakers, infusion pumps, ventilators, defibrillators |
| Surgical instruments | Scalpels, electrosurgical units, laparoscopic instruments |
| Implants | Hip replacements, stents, cochlear implants, breast implants |
| Software (SaMD) | AI-powered diagnostic software, clinical decision support |
| Wound care | Wound dressings, surgical drapes (with medical claims) |
| Dental devices | Dental implants, orthodontic brackets, dental chairs |