Technovigilance is in charge of monitoring the safety of Medical Devices and this, in turn, is a set of activities where all the information related to the risks of any verified event related to the use of a medical device is evaluated and identified (through conclusive evidence), and that could be caused by a malfunction or alteration of the characteristics of the Medical Device (MD) and that could cause the death or serious deterioration of the health of the user. This is carried out through notification, to identify the frequency and severity of adverse incidents in order to prevent them, and if they exist, reduce them.

One of the main activities through which our health authorities (COFEPRIS) monitor the safety of Medical Devices in Mexico is through the Technovigilance Report, which is a document that includes all the safety information that has been compiled in the last 5 years of the medical device in question and that is presented before the CEMAR (Evidence and Risk Management Commission) particularly before the Executive Directorate of Pharmacopoeia and Pharmacovigilance, and is a requirement for the process of renewal or extension of a Sanitary Registration. In addition, it is included in the Technovigilance installation and operation standard.

In accordance with our regulation, the holder of the Sanitary Registration domiciled in Mexico is the one who must present the Technovigilance report, as indicated in NOM-240-SSA1-2012, Installation and operation of Technovigilance, at least 240 calendar days before the expiration date of the Sanitary Registration. In the case of a first extension request, the period covered is a minimum of 4 years; after the first extension the period will be 5 years.

The Technovigilance report is made up of the following:

1. Cover: Data of the MD and data of the holder according to the Sanitary Registration, data of the Sanitary Responsible, period covered by the ITV and date of preparation.

2. Monograph: All the information corresponding to the MD such as: Generic and distinctive name, type of input and classification of the MD (according to the Mexican regulation), information on the manufacturer, distributor and importer, indications for use, precautions, contraindications, presentations (only the models/codes/references that have been marketed during the ITV period), Serial number, batches or presentations that have been presented, adverse incidents, corrective, preventive and corrective field safety actions in the national territory and software version .

3. Safety data sheet in Mexico: General data from the MD, time spent in the national market (years and months), number of units marketed in Mexico per year, total units marketed during the ITV period, data that can help to estimate the number of patients exposed (calculation method), total number of reported adverse events, total number of reported serious adverse events, and total number and description of unforeseen adverse events.

4. Annexes: Copy of the Sanitary Registration, Copy of the Official Letter of registration of the Technovigilance unit and person responsible for the ITV, insert or equivalent, security sheet (as applicable for the type of MD).

The above information must be submitted to the aforementioned regulatory entity, through the COFEPRIS Comprehensive Services Center, in writing.

On April 25th, the Executive Directorate of Pharmacopoeia and Pharmacovigilance issued an official letter indicating that as of June 2023 the ITV must be submitted electronically either on a USB memory or CD containing: the monograph, safety sheet in Mexico and annexes. Each document must be as a separate file in PDF format. Only the cover and a simple copy of the Sanitary Registration must be presented in print.

*Source: Official Mexican STANDARD NOM-240-SSA1-2012, Installation and operation of Technovigilance.