Overview
The Mexican market regulator, COFEPRIS, published in the second half of 2024 a new draft NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This draft will be open for suggestions and comments until September 29, 2024.
Introduction
This new draft expands the number of definitions and stakeholders in the National Technovigilance System. Examples include supply chain, information quality, medical device deficiencies, risk management, clinical study reporting, trend reporting and quality management system.
As a result of these additional definitions, the distributor will have the obligation to inform the Mexican Registration Holder (MRH) of any adverse incident related to the medical device. This process must be formalized in the technical agreement between the manufacturer, distributor and MRH, in accordance with NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices.
Software is now included in the scope, reflecting last year’s updates to the Mexican Pharmacopoeia’s Medical Devices Supplement.
The draft also establishes that errors during use will trigger a trend analysis based on risk management, to determine the corrective safety actions to be taken (Field Safety Corrective Action).
Accountability
A relevant review highlights the need to submit open inquiries to notify authorities of the following scenarios that may impact the surveillance of medical devices:
- Transfer of rights to new registration holders
- Cancellation or withdrawal of registration
- Theft, falsification or loss of any medical device
- Updates to clinical protocols
- In addition, safety alerts (national or international) must be notified to the authority and tracked by all Technovigilance Units.
- It is now explicitly required to report adverse incidents that occur during clinical trials, even if the medical devices involved do not yet have marketing authorization.
- The information provided is now classified into three quality levels (1, 2 and 3), with level 1 being the minimum requirement for reporting.
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. |
Important considerations
For the success of Technovigilance activities, it is essential that everyone involved is properly trained and informed about the latest updates in surveillance regulations.
An “Administrative Guide for Reporting Incidents and Adverse Events in Medical Products” will be published to complement this project. However, there is not yet a draft available or a date set for its publication.
Although no significant changes to this draft are expected, will closely monitor any update on its publication in the Official Gazette, making this update officially valid.
GRP México Services
GRP Mexico can help with device registration and IVD in Mexico. The GRP Mexico team is made up of experienced bilingual management professionals, so we understand what it takes to get your device approved in the most efficient way possible. Let’s go:
- Local Representation
- Determine the classification and registration route for your medical device or IVD.
- Help define a grouping strategy for your directory, if applicable.
- Determine the documents required for your registration journey.
- Act as an Independent Registered Owner in Mexico. Prepare and submit the application to COFEPRIS.
- Answer COFEPRIS’ questions during submission.
- Mexico is a growing Latin American market that relies almost entirely on imports. This makes it a lucrative market for device manufacturers.
- Warehousing and Storage
- Importation and Customs Clearance
Learn more about Cofepris
Brochure : GRP Mexico Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their products with the Mexico's Cofepris the local Health Authority (HA)
Brochure : GRP USA Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners Group
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.