What is Not a Medical Device?
Not every health-related product is a medical device under Mexico's Reglamento de Insumos para la Salud. Understanding the boundaries of COFEPRIS jurisdiction saves time and avoids unnecessary registration.
Products regulated separately
| Product type | Regulated as | Regulator |
|---|---|---|
| Medicines (pharmaceuticals) | Medicamentos | COFEPRIS (pharmaceutical division) |
| Biological products | Biológicos | COFEPRIS |
| Cosmetics | Cosméticos | COFEPRIS (cosmetics division) |
| Foods and nutritional supplements | Alimentos / Suplementos alimenticios | COFEPRIS / SENASICA |
| Veterinary products | Insumos veterinarios | SENASICA / SAGARPA |
Annex 3 — products not classified as health supplies
The July 2025 COFEPRIS classification decree introduced Annex 3, which explicitly lists products that are not considered health supplies and therefore require no sanitary registration or import permit. Examples include:
- Laboratory reagents not intended for clinical diagnosis
- Hospital furniture (beds, trolleys, storage)
- General cleaning and disinfection products
- Personal protective equipment (PPE) for non-medical use — however, PPE intended for medical/healthcare settings may still require registration; verify with COFEPRIS
- Laboratory glassware and consumables (general purpose)
Annex 3 was published in the Diario Oficial de la Federación (DOF) in July 2025. COFEPRIS periodically updates the Annexes; before submitting a product classification inquiry or import permit application, always verify your product against the current DOF-published text on the COFEPRIS official website or consult COFEPRIS directly via DIGIPRiS.
Products that achieve their principal action by pharmacological means
If a product achieves its primary intended effect via pharmacological, immunological, or metabolic means, it is a medicine, not a medical device — even if it has a physical component (e.g., drug-eluting stents are classified as combination products).
Software — when it is and is not a medical device
Not all software used in healthcare is a medical device. COFEPRIS has begun aligning with IMDRF SaMD guidance. General wellness apps, administrative software, and tools that simply store or transmit data without clinical decision-making are generally not regulated as medical devices.
See Software & SaMD classification for detail.