| COFEPRIS | Federal Commission for the Protection against Sanitary Risks | Mexico's federal health regulatory authority, a division of the Ministry of Health (SSA). |
| Registro sanitario | Sanitary registration | COFEPRIS market authorisation required before a medical device can be sold in Mexico. |
| Insumos para la salud | Health supplies | The broad category including medical devices, medicines, and diagnostic agents regulated under the Reglamento. |
| Dispositivo médico | Medical device | Any instrument, apparatus, or accessory meeting the definition in the Reglamento de Insumos para la Salud. |
| Reglamento de Insumos para la Salud | Health Supplies Regulation | The secondary legislation implementing the Ley General de Salud for medical devices. |
| NOM (Norma Oficial Mexicana) | Official Mexican Standard | Mandatory technical standards issued by the relevant government ministry. For medical devices, NOMs are issued by SSA/COFEPRIS. |
| MRH (Mexico Registration Holder) | Mexico Registration Holder | The legally constituted Mexican entity that holds sanitary registrations on behalf of a foreign manufacturer. |
| Responsable Sanitario | Health Manager | A qualified professional required at manufacturing, import, and distribution facilities to oversee compliance. |
| Homoclave | Homoclave (registration code) | The alphanumeric code COFEPRIS assigns to each application type; used to identify the registration pathway. |
| DIGIPRiS | — | COFEPRIS's online portal for all regulatory submissions and permits. |
| DOF (Diario Oficial de la FederaciĂłn) | Official Journal of the Federation | Mexico's official government gazette where all laws, regulations, and NOMs are published. |
| CNFV | National Centre for Pharmacovigilance | The COFEPRIS division responsible for receiving and assessing adverse event reports for medicines and medical devices. |
| Tecnovigilancia | Technovigilance | Mexico's post-market surveillance system for medical devices (equivalent to EU vigilance or FDA MDR). |
| FSCA | Field Safety Corrective Action | Action taken to reduce risk from a device already placed on the market — corresponds to a recall or correction. |
| Ruta de equivalencia | Equivalency Route | Fast-track registration pathway for devices already approved by an IMDRF or MDSAP-recognised authority. |
| RRA (Autoridad Regulatoria de Referencia) | Reference Regulatory Authority | A foreign authority whose approvals are recognised by COFEPRIS for the equivalency route (e.g., FDA, EMA, TGA, Health Canada). |
| PANDRH | Pan American Network for Drug Regulatory Harmonization | Regional regulatory harmonisation network including Mexico and other PAHO member states. |
| IMDRF | International Medical Device Regulators Forum | Global forum of medical device regulatory authorities; COFEPRIS is a member. |
| MDSAP | Medical Device Single Audit Programme | International QMS audit programme whose certificates are recognised by COFEPRIS for the equivalency route. |
| CFS | Certificate of Free Sale | Document from a reference authority confirming a device is approved for sale in its home market; required for the equivalency route. |
| Aviso de funcionamiento | Notice of operation | COFEPRIS authorisation required for manufacturing, import, and storage facilities operating in Mexico. |