Overview
On December 20, 2021, COFEPRIS updated NOM-241-SSA1-2012 after a decade, reflecting significant technological advancements in the medical industry.
The new regulations, NOM-241-SSA1-2021, will supersede the existing regulations and will be fully implemented by June 2023.
Key Updates
The new regulations provide:
- Greater order to the specifications at each stage of a medical device's life cycle, focusing on the Quality Management System.
- An expanded classification of medical devices to now include any instrument, device, utensil, machine, software, implantable products or materials, diagnostic agents, materials, substances, or similar products used directly or indirectly on humans.
The designation of "software" as a medical device is crucial as it clarifies the role of software in connection with medical devices.
Sanitary Registration for Smartwatches
As a result of this regulatory update, COFEPRIS announced in January 2022 that smartwatches would undergo analysis for Sanitary registration. Today, many smartwatches allow users to monitor their heart rate and other health indicators through software. With this inclusion, COFEPRIS recognizes software as a regulated product. Starting January 2022, COFEPRIS will officially review all technical and medical information related to smartwatches before they are imported into Mexico. After the review, manufacturers will be informed whether a Sanitary Registration is required on a case-by-case basis.
Despite the regulation, NOM-241-SSA1-2012, not being officially modified to include smartwatches as medical devices, this announcement reflects COFEPRIS's alignment with the 116 countries that classify smartwatches with health functions as medical devices. This advancement follows the introduction of electrocardiogram capabilities in some smartwatches since 2018, symbolizing Mexico's commitment to updating its regulations.
Reference
Official Reference - https://dof.gob.mx/nota_detalle.php?codigo=5638793&fecha=20/12/2021