What is Not a Medical Device?
Products excluded from device regulation
| Category | ANVISA category | Key distinction |
|---|---|---|
| Drugs (medicamentos) | Drug regulation | Achieves primary action by pharmacological/immunological/metabolic means |
| Biological products (biológicos) | Biological regulation | Vaccines, blood products, cell therapy |
| Cosmetics | Cosmetics regulation (RDC 752/2021) | No medical claim; intended for appearance/hygiene only |
| Food and dietary supplements | Food regulation (ANVISA/MAPA) | Intended for nutrition, not diagnosis or treatment |
| Pesticides | IBAMA/MAPA regulation | Not intended for human diagnostic or therapeutic use |
| General hospital furniture | No ANVISA registration required | Beds, trolleys with no medical function claim |
The intended purpose test
A product that makes no medical claim does not require ANVISA medical device registration — regardless of its physical form. However, if promotional materials, labelling or IFU introduce a medical claim, the product becomes subject to device regulation.
ANVISA enforcement has targeted products marketed as "wellness devices" that make implied diagnostic or therapeutic claims. If in doubt, seek a consulta de enquadramento (classification inquiry) from ANVISA before or "lifestyle" products claims through labelling, packaging, promotional materials, or clinical claims. Examples include devices marketed as improving sleep quality, enhancing cognitive function, or treating minor pain without explicit medical launch — submitting this inquiry formally creates a regulatory record of your good-faith classification effort.
Official resources
Note: While drugs and biologics are regulated under separate ANVISA frameworks, both are excluded from medical device regulation. Drugs achieve their primary action through pharmacological, immunological, or metabolic means, while biologics are products derived from biological sources (including vaccines, blood products, and cell therapies). Consult ANVISA's classification guidance if uncertain whether a product is a drug, biologic, or device.