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What is a Medical Device?

In Mexico, the definition of a medical device (dispositivo médico) is established in the Reglamento de Insumos para la Salud (Health Supplies Regulation), which implements the Ley General de Salud (General Health Law).

Under the Reglamento de Insumos para la Salud, medical devices (insumos para la salud) broadly encompass:

  • Medical equipment (equipo mĂ©dico) — instruments, apparatus, devices, and accessories intended for use in medical or surgical care, examination, diagnosis, treatment, or rehabilitation.
  • Prostheses, orthoses, and functional aids — devices that supplement or replace body structures or functions.
  • Diagnostic agents (agentes de diagnĂłstico) — reagents, kits, and instruments used for in vitro diagnosis.
  • Dental devices (materiales dentales) — products intended for dental procedures.
  • Surgical and healing materials — sutures, dressings, wound care products.

The three-part intent test​

A product is generally a medical device in Mexico if it is:

  1. Manufactured, sold, or presented for use in humans.
  2. Intended for prevention, diagnosis, treatment, monitoring, or alleviation of disease, injury, or disability — or for investigation, replacement, or modification of anatomy or a physiological process.
  3. Does not achieve its principal intended action by pharmacological, immunological, or metabolic means (distinguishing it from a medicine).

COFEPRIS — the regulatory authority​

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the federal body within the Ministry of Health (Secretaría de Salud) responsible for regulating medical devices. All devices placed on the Mexican market — manufactured domestically or imported — fall under COFEPRIS jurisdiction.

Key principle

The definition is broad. When in doubt whether a product is a medical device, consult the Reglamento de Insumos para la Salud and COFEPRIS classification guidance, or seek advice from a qualified regulatory affairs professional.