Ley General de Salud (General Health Law)
The Ley General de Salud (LGS) is Mexico's primary federal health legislation. Published in the Diario Oficial de la FederaciĂłn (DOF) and periodically amended, it establishes the constitutional mandate for health protection in Mexico and creates the regulatory framework within which COFEPRIS operates.
Role in medical device regulation​
The LGS does not prescribe technical device requirements in detail — that is left to the Reglamento de Insumos para la Salud and the NOMs. Instead, it:
- Establishes the legal requirement for sanitary registration before medical devices may be manufactured, imported, or commercialised in Mexico.
- Creates COFEPRIS as the federal authority responsible for health risk protection.
- Defines the scope of health supplies (insumos para la salud), including medical devices.
- Grants COFEPRIS authority to inspect, sanction, and enforce compliance.
- Provides the framework for advertising and promotion controls.
- Enables the issuance of the Reglamento de Insumos para la Salud and the NOMs as secondary legislation.
Key titles and articles relevant to medical devices​
| Title / Article | Subject |
|---|---|
| Title First — Constitutional Right to Health | Overall mandate for health protection |
| Title Tenth — Health Supplies (Insumos para la Salud) | Medical devices, medicines, diagnostic agents |
| Articles 194–205 | Sanitary control of health supplies; registration requirements |
| Article 194 | Definition of health supplies (devices, medicines, diagnostic agents) |
| Article 197 | Requirement for sanitary registration before commercialisation |
| Article 198 | Products requiring sanitary registration |
| Articles 257–267 | Research with human subjects (relevant for clinical investigations) |
| Title Eighteenth — Sanctions | Penalties for non-compliance |
The current text of the Ley General de Salud is available through the official Cámara de Diputados website (www.diputados.gob.mx) and is updated each time an amendment is published in the DOF.
Amendments and currency​
The LGS is amended through regular legislative activity. Major amendments relevant to medical devices include provisions introduced to address digital health, telemedicine, and the regulatory powers of COFEPRIS. Always verify you are using the most current consolidated version.