Mexico COFEPRIS Revises Draft of Technovigilance Standard

By Ana Karen Hidalgo Rodríguez, Dicsy Solano and Nélyda González

Background on NOM-240-SSA1-2024

The regulator in Mexico, COFEPRIS, released on July 24, 2024, a new draft for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This update follows a trend of recent revisions over Mexican Standards (Emergo reported on PROY-NOM-137-SSA1-2024, Medical Device Labeling). The current version of NOM-240 was published in 2012, so an update was overdue to align with technology developments and international requirements. The draft is open for input and comments until September 29, 2024.

Significant updates in PROY-NOM-240-SSA1-2024 compared to the current NOM

Concepts

This new draft increases the number of definitions and stakeholders of the Technovigilance National System. Some examples include supply chain, quality of information, deficiencies on medical devices, risk management, clinical study report, trend report and quality management system.

As an outcome of these additional definitions, the distributor will have the obligation to communicate to the Mexico Registration Holder (MRH) of any adverse incident related to the medical device. This process shall be reflected on the technical agreement between the manufacturer, distributor and MRH, per NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices.

Software is now included as part of the scope, reflecting last year’s updates from the Supplement of Medical Devices of the Mexican Pharmacopoeia.

The draft states that errors during use will trigger trend analysis based on risk management to determine the following steps to be taken (Field Safety Corrective Action).

Reportability

A significant revision considers the need to submit open inquiries to inform the authorities of the below scenarios that can impact the vigilance of the medical devices:

Rights transfers to new registration holders
Cancellation or withdrawal of the registration
Robbery, falsification or loss of any medical device
Updates in the clinical protocols
Security alerts (national/international) must be notified to the authority and tracked by all the Technovigilance Units
It is now explicitly required to report Adverse Incidents that take place during clinical trials, even if the medical devices involved don’t yet have an existing marketing authorization
The information provided is now categorized through degrees of quality (1, 2 and 3) with 1 being the bare minimum requirement for reporting

Reporting timelines

Report type	Initial reporting timeframe	Follow/final reporting timeframe
Serious public health threat	No later than 3 calendar days after the confirmation of the event*.	It will be defined by the National Center for Vigilance and the MRH.
Security alerts of devices commercialized in Mexican territory	No later than 5 calendar days after having all the required information.	No later than 6 months, with possibility to request an extension for 6 more months after the initial or subsequent notification as applicable.
Unexpected adverse incidents	No later than 7 calendar days after the awareness of the event.	No later than 15 business days after the initial notification
Death or serious deterioration in the user's health	No later than 10 calendar days following the date of confirmation event*.	No later than 6 months, with possibility to request an extension for 6 more months after the initial or subsequent notification as applicable.
Others	No later than 30 calendar days following the date of awareness of the event.	No later than 6 months, with possibility to request an extension for 6 more months after the initial or subsequent notification as applicable.
FSCA	No later than 30 calendar days after having all the required information.	No later than 6 months upon the initial notification, in accordance with the strategy developed from the risk management analysis.

*The draft does not state awareness of the event, but rather confirmation of the event.

Concluding remarks

It is crucial for the Technovigilance activities that all the participants involved are appropriately trained and informed regarding the latest updates over vigilance regulation.

An “Administrative Guide for Reporting Medical Device Incidents and Adverse Events” will be published to complement this project, however, there’s still no available draft or publication date.

No significant changes are expected over this draft, but Emergo will monitor closely any updates over its publication in the official journal, rendering this update official.

Additional COFEPRIS resources from Emergo by UL