Pure Global AI
COFEPRIS NOM-241-SSA1-2025

NOM-241-SSA1-2025

Good Manufacturing Practices for Medical Devices (2025)
MexicoCOFEPRISGMP/QMSEffective November 30, 2025
Official source linked
What this code is

NOM-241-SSA1-2025 is the official COFEPRIS identifier for “Good Manufacturing Practices for Medical Devices (2025)”. NOM-241-SSA1-2025 is the official identifier COFEPRIS uses for this instrument.

Instrument
NOM-241-SSA1-2025
Full name
NOM-241-SSA1-2025
Category
GMP/QMS
Source links
Authority source
Spanish
Open the issuing-authority text
Authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
27 articles · 1 language version
Read the full text →
Direct citations can link to an article, for example /data/regulations/mexico/nom-241-ssa1-2025.es.html#art-1.
Dates
Published
April 4, 2025
Effective
November 30, 2025
Readable full text

Open a language version

Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

Spanish full text27 articles · Spanish — official textRead HTML →
About this regulation

Good Manufacturing Practices for Medical Devices (2025)

Updated GMP standard for medical devices. Removes classification chapter (now in Mexican Pharmacopoeia Supplement 5.0). Aligns with ISO 13485:2016. Replaces NOM-241-SSA1-2021.

NOM-241-SSA1-2025 is the official identifier COFEPRIS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

Verified