Technovigilance Unit

Introduction
Technovigilance consists of monitoring the reactions produced by medical devices. The information on the Adverse Reactions can be generated by notification of the medical institutions or public consumers that maintain adequate monitoring of these reactions in order to report the symptoms caused by the device used. Technovigilance must ensure that any medical device that is commercialised in Mexico meets the requirements as indicated by the manufacturer. Otherwise, corrective actions are taken in order to reduce the occurrence of adverse events/incidents to offer greater protection and security for its users.
Objective and importance
The purpose Regisan's Technovigilance Unit is to provide support to holders of sanitary registration of medical devices and/or their legal representative in Mexico, to carry out the appropriate surveillance of the devices, in this way guaranteeing the safety of the products and having the protection to patients.

Specific activities of the Technovigillance Unit
 

  • Training for all personnel involved in the management of medical devices
  • Standard Operating Procedures
  • Control and protection of documents
  • Traceability of the medical device
  • Initial notification of adverse events/incidents
  • Follow-up and final report
  • Technovigilance report (renewal of records)
  • Compliance with notification dates to the CNFV
  • Coordinated participation with the CNFV in accordance with the provisions established by the CNFV
  • Among others

Notification Process

    • All notifications must be sent to the CNFV in writing.
    • Comply with the notification times of the initial, follow-up and final report according to what is specified in Standard NOM-240-SSA1-2012 issued by the National Pharmacovigilance Center of COFEPRIS.
    • Renewal of the marketing authorization.
    •  

REGISAN service modalities   1.
1. Organization and internal training of the technovigilance areas.
2. External presentation of the specific activities of the Technovigilance Unit

3. Staff organization and training

Literature References

  •  
  • • NOM-240-SSA1-2012, Installation and operation of the technovigilance
  • • NOM-137-SSA1-2008, Labeling of medical devices
Requires technovigilance
Medical devices Class I

Class I: Those supplies that are known in medical practice and that their safety and efficacy are proven and, generally, are not introduced to the body.

Requires technovigilance
Medical devices Class II

Those supplies that are known in medical practice and that may have variations in the material with which they are made or in their concentration and, generally, are introduced to the organism staying less than thirty days.

Requires technovigilance
Medical devices Class III

Those supplies recently accepted in medical practice or that are introduced to the body and remain there for more than thirty days.

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