COFEPRIS
The decentralized body of Mexico’s Ministry of Health responsible for health regulation, control and oversight. Its authorizations must be available as evidence; some, including health registrations, expire.
RegulatoryFederal Commission for Protection against Health Risks
The decentralized body of Mexico’s Ministry of Health that regulates, controls and oversees products and facilities posing health risks: medicines, medical devices, food, supplements, cosmetics and the facilities where they are made or stored.
The records it generates
Health registrations, licenses, permits, operating notices and supporting technical records. Under the law’s general rule, health authorizations have an indefinite term; health registration is the exception, lasting five years and renewable at the holder’s request. All remain subject to physical or documentary verification, which the law permits without prior notice; the written order is delivered when the visit begins.
Where it matters
At renewal. A health registration not renewed on time can be canceled by the authority, preventing the product from being sold or supplied. Teams working under this authority need visible dates to avoid losing market access.
Read alongside
Document practice
Document validity
The period during which a document takes effect, managed as part of its record rather than a personal reminder.
ReadDocument practice
Single record
One authoritative document record for a matter, rather than separate copies across departments.
ReadDocument practice
Document traceability
An automatically generated record of who changed a document, what changed and when, including the previous and new values.
Read
Reactive compliance served its time.
Today’s environment rewards control.
Request a strategic session to identify your area of greatest risk and leave with a clear plan to get started.