The legal framework for medical devices in Mexico involves several responsibilities for the Mexican Registration Holders (MRH), including compliance with local standards known as Mexican Official Norms (NOM). In fact, one of the applicable NOMs is the NOM-240-SSA-2012 in relation to the Establishment and Operation of Technovigilance Programs in the country. This NOM is the equivalent to the post market surveillance or incident reporting programs in other countries.
In a previous article we have described the definitions, responsibilities and timelines to reporting incidents to the National Center of Pharmacovigilance (CNFV) through COFEPRIS. In this text we will review in more detail the process to notify incidents related to medical devices commercialized in Mexico.
Who must notify
NOM-240 establishes that MRHs, manufacturers, distributors, and sellers have the responsibility of notifying incidents related to their medical devices approved and sold in Mexico. However, it is expected that the MRH performs and coordinates such activities with all the parties involved.
Which person is responsible
All MRHs must have a Technovigilance Unit (TU). This is the physical location where Technovigilance activities takes place. Within the TU, there must be a responsible (who can be the Sanitary Responsible). In any case, the Responsible of the TU needs to be trained in the NOM-240 and be experienced with handling of Technovigilance activities.
How to notify
There are two ways to submit a notification in COFEPRIS related to incidents:
- Using the official format and submitting a hardcopy in the CIS. The format must be filled in all the required fields and be signed by the Responsible of the TU.
- With the aid of the web platform, filling the requested fields and sending the notification digitally. The notification is sent electronically and does not require authentication of the TU Responsible, just accepting the terms and conditions of the site.
What information is needed
All initial notifications contain the same information regardless of being sent digitally or physically. Here we summarize the information that is requested:
- Sanitary Registration number
- Date of notification
- Notifier details
- Operator of the medical device
- Patient general data
- Type of incident
- Place where the incident occurred
- Description of the incident
- Consequence of the adverse incident
- Medical device identification
- Classification of the device
- Activities performed
In addition to this information, more details can be required to identify if the incident represents a risk for the population health. Finally, all notifications must be followed up and closed through a final notification including the preventive and corrective actions or the results of the investigation.
It is important to store all notifications sent to COFEPRIS because those be needed to create the Technovigilance Reports that are a requirement for the renewal process.
Technovigilance activities are complex and time-consuming activities that must be carried out by all the MRHs to follow the legal framework for medical devices in Mexico. If you need support in your Technovigilance Unit, notifications and/or reports, please contact us at email@example.com