[Emergo, UL] Mexico COFEPRIS Revises Draft of Technovigilance Standard

 

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

1. 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).

 

 

Mexico COFEPRIS Revises Draft of Technovigilance Standard | Emergo by UL

Mexico COFEPRIS Revises Draft of Technovigilance Standard

---