Health law reform: registrations extendable for ten years
Published 15 January 2026 · Ley General de Salud
What changed
A reform of the Ley General de Salud keeps the five-year sanitary registration for medicines and medical devices but allows extensions for ten-year terms on request; missing the extension deadline, or changing the product or raw-material maker without approval, cancels it. A new article 262 Bis places registered medical devices under incident monitoring (tecnovigilancia).
Who it affects
Health, pharmacy and OTC, Dental and medical. Product types on our rules page: Medicines and supplements, Medical devices.
The source and its dates
Ley General de Salud, consolidated text, Cámara de Diputados. Published 15 January 2026; in force from 16 January 2026. Checked against the source on 11 October 2026.
What to do
If you hold a sanitary registration for a medicine or medical device, diarise its five-year date now and file the extension request in time: a missed deadline, or a change of product or raw-material maker without approval, cancels it. Device holders also need an incident-monitoring (tecnovigilancia) process in place.
Your customs broker, accountant or lawyer files and signs; this page sets out the rule and its source. Need it for your own case? Write to us.