Technovigilance (TV) refers to all activities aimed at monitoring the safety of medical devices (MDs) in use, identifying and evaluating incidents and adverse incidents, as well as the risk factors associated with them.
Among the parties obligated to carry out these activities are sanitary registration holders, distributors, and marketers of medical devices within national territory.
- Responsibilities
| Sanitary Registration Holders | Distributors and Marketers |
| -Have a Technovigilance Unit (TVU) -Appoint a person responsible for the TVU -Develop, keep updated, and implement Standard Operating Procedures (SOPs) -Report Adverse Incidents (AI) -Implement Field Safety Corrective Actions (FSCA) -Submit the five-year Technovigilance Report | -Have a Technovigilance Unit (TVU) -Appoint a person responsible for the TVU -Develop and keep SOPs updated -Inform the registration holder of any incident or adverse incident -Collaborate with the sanitary registration holder by providing information related to TV activities |
2. Registration of the Technovigilance Unit (TVU)
Both sanitary registration holders and distributors/marketers of medical devices must register their TVU through a free-format letter addressed to the National Center for Pharmacovigilance (CNFV) and submitted at the Comprehensive Service Center (CIS) of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
The information required for registration includes:
- Type of establishment (registration holder or distributor/marketer)
- Owner or establishment information
- TVU information: address, telephone number, and email
- Information of the TVU responsible person and alternate (optional): name, email, professional title, and professional license number
- Declaration of compliance with SOPs
- Annexes: Notice of Operation, official identification of the legal representative and the TVU responsible person
3. Person Responsible for the Technovigilance Unit
The TVU responsible person must be a healthcare professional who demonstrates competence in technovigilance. This individual will be responsible for coordinating, implementing, and maintaining the unit’s activities and will be the sole valid point of contact with the CNFV.
- SOPs (in accordance with PROY-NOM-241-SSA1-2024)
The SOPs to be developed and implemented are as follows:
| Sanitary Registration Holders | Distributors and Marketers |
| -Training and dissemination of technovigilance activities -Detection of duplicate notifications of Incidents and Adverse Incidents (IAI) -Technovigilance reporting IAI investigation -Reporting and submission of adverse incidents -Receipt, registration, coding, and archiving of IAI -Trend reporting based on risk management FSCA reporting and follow-up -Safety alert monitoring | -Training and dissemination of technovigilance activities -Detection of duplicate notifications of IAI -Reporting and submission of adverse incidents -Receipt, registration, coding, and archiving of IAI |
5. Reporting of Adverse Incidents (IAI)
The reporting of Adverse Incidents (IAI) is the responsibility of sanitary registration holders and is conducted through the Online System for Reporting Incidents and Adverse Incidents of Medical Devices, available on the official COFEPRIS website:
https://www.gob.mx/cofepris/acciones-y-programas/sistema-en-linea-de-notificacion-de-incidentes-adversos-de-dispositivos-medicos
The system includes mandatory fields for each technovigilance participant submitting a report, ensuring compliance with applicable quality criteria according to the notifier.
There are three criteria to determine whether an AI must be reported to the authority:
- First criterion: The AI occurred in Mexico.
- Second criterion: There is a causal relationship between the AI and the use of the medical device.
- Third criterion: The AI resulted in death or serious deterioration of health.
5.1 Possible actions following an IAI
- Market withdrawal
- Medical device modification
- Software update
- Labeling changes
- User notification
6. Field Safety Corrective Actions (FSCA)
The sanitary registration holder is responsible for implementing FSCAs. These actions must be taken when there is knowledge that an incident involving a medical device marketed has occurred, posing an unacceptable increase in risk during use. This includes:
- Malfunction or deterioration of safety
- Quality or performance issues of a marketed medical device
- Any deficiency in the information provided by the manufacturer
- Undesirable side effects
6.1 FSCA Report Content
- Description of the problem prompting the action
- Information on the medical device marketed in Mexico (sanitary registration, model, code, catalog, reference, batch, serial number)
- Health risks and their consequences
- List of potentially affected clients
- Root Cause Investigation report
- Actions to be taken to resolve the problem
- Actions to prevent recurrence
- Start date and estimated completion date
6.2 FSCA Annexes
- Simple copy of the safety notice in the original language and Spanish translation
- Simple copy of the sanitary registration
- Evidence supporting all actions taken
- In the case of a market withdrawal, the number of units recovered and their final disposition
RECOMMENDATION: Reference the internal FSCA number; for follow-up or closure of an FSCA, reference the CIS number of the initial report submission and subsequent follow-ups, as applicable.
Currently, there is no fixed deadline for action closure; this will depend on the complexity of the FSCA.
7. Technovigilance Report (TVR)
Sanitary registration holders must prepare and submit the TVR every five years as part of the registration renewal process.
Submission must be made three months before the planned application date for renewal and must cover the following periods:
- First renewal: Minimum evaluation period of four years
- Subsequent renewals: Five-year period following the cutoff date of the last report
7.1 TVR Structure
- Cover page
- Brief monograph
- Safety technical data sheet in Mexico: description and total number of AIs (if applicable), number of units marketed per year in Mexico, time on the market, and number of exposed patients
- Annexes: simple copy of the sanitary registration and the official letter recognizing the TVU responsible person
- Administrative Guide for the Preparation of the Technovigilance Report | Federal Commission for the Protection against Sanitary Risks | Government | gob.mx
7.1.1 Marketed units
It is recommended that marketed units be declared in the technical data sheet using a table, as shown below:
(Units marketed per year)
| Presentations / Models | 2020 | 2021 | 2022 | 2023 | Total |
|---|---|---|---|---|---|
| Model 1 | 1 | 3 | 5 | 7 | 16 |
| Model 2 | 3 | 4 | 6 | 9 | 22 |
| Subtotal | 4 | 7 | 11 | 16 | 38 |
7.1.2 Estimation of exposed patients
Depending on the type of medical device, exposed patients should be estimated as follows:
a) Single-use devices: Number of exposed patients equals unit sales.
b) Reusable devices: Estimate the number of times the device can be used based on design, demand, presentations, and expected useful life.
c) Medical equipment: Consider the shortest procedure time to determine the number of procedures per day and extrapolate over the evaluation period, taking into account the device’s useful life. Consider the installed base plus equipment sold per year.
d) Diagnostic agents: Calculate based on clinical characteristics, intended use, and performance according to marketed presentations. Sample yield per presentation minus 10% for waste per agent.
It is essential that, if you are a sanitary registration holder of medical devices or are involved in their commercialization and distribution, you comply with this obligation as part of the lifecycle of your devices, prioritizing user safety at all times.
Source:
- First Technovigilance Session for Registration Holders
- DRAFT Official Mexican Standard PROY-NOM-240-SSA1-2024, Installation and Operation of Technovigilance
- Official Mexican Standard NOM-240-SSA1-2012, Installation and Operation of Technovigilance
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