One of the key activities that any sanitary registration holder in Mexico must perform after obtaining the marketing authorization is the technovigilance. This is mandatory for holders and Medical Device distributors according to the NOM-240-SSA-2012. In our blog, you can find two articles describing the generals of Technovigilance and how to handle notifications.
In this article, we will focus on tecnnovigilance reports (TR) and its main characteristics.
What is a Technovigilance Report (Informe)?
This is a document elaborated by the sanitary registration holder each five years after the approval of the sanitary registration. This report contains general information of the medical device registered in Mexico and the adverse incidents occurred in the timeframe the device was marketed or used in Mexico.
What is the purpose of these reports?
These reports are sent to the National Center of Pharmacovigilance (CNFV), a commission inside COFEPRIS, with the purpose of demonstrating that the medical device is safe and can be kept in the market. Thus, technovigilance reports are included as a requirement in the renewal process of a registration (every five years).
When should the report be submitted?
According to the point 6.7.12.5 of the NOM-240-SSA-2012, technovigilance reports must be delivered to the CNFV at least 3 months before starting the renewal process for any registration. On the other hand, the article 190 bis 6 of the Health Supplies Regulation, indicates that all renewals must be requested at least 5 months before the expiration date of the registration. Consequently, technovigilance reports must be submitted at least 8 months before the sanitary registration expiration date.
What are the general characteristics of a report?
- Elaborated by the technovigilance unit of the sanitary registration holder
- Cover letter indicating that the document is a report (informe)
- Addressed to Executive Direction of the Pharmacopea and Pharmacovigilance
- Include the signature of the technovigilance responsible unit
- Comply with requirements referred in the point 6.7.12 of the NOM-240-SSA-2012.
- Contain market information related to the last 5 years of the device in Mexico (4 years for the 1st period)
- Can be presented in tables and/or according to the Guide for TR issued by COFEPRIS
What information a report must include
- Sanitary Registration number
- Expiration date of the registration
- Generic and distinctive name
- Sanitary Registration Holder name
- Technovigilance Unit and Responsible of that unit
- Period of the report
- Medical device category and risk class
- Manufacturer(s)
- Distributor(s)
- Number of devices marketed
- Number of adverse incidents
Conclusions
Reports are essential documents to maintain a sanitary registration valid. The elaboration of a technovigilance report involves a series of activities that must be performed by the responsible of the technovigilance unit according to the applicable NOM-240-SSA-2012. If you need support building these reports or accomplish other technovigilance responsibilities, please contact us at contact@veraqueconsulting.com.
