In the medical device sector, safety and regulatory compliance are fundamental to ensuring quality and protecting patients. A key aspect of this process is traceability within the supply chain. As distributors, sharing updated information, such as the Notice of Operation and the Registration of the Tecnovigilance Unit, with the sanitary registration holder is not only a regulatory obligation but also an essential practice to ensure operational continuity and avoid setbacks in procedures with COFEPRIS.
Essential Documentation for Safe and Efficient Distribution
The Notice of Operation, regulated by NOM-241-SSA1-2021, certifies that an establishment meets the sanitary requirements to operate and distribute medical devices. For its part, NOM-240-SSA1-2012 establishes the obligation to have a Tecnovigilance Unit responsible for supervising medical devices and monitoring adverse incidents.
Since both the Notice of Operation and the Registration of the Tecnovigilance Unit can be modified due to various circumstances, it is crucial to share this information with the sanitary registration holder. This facilitates traceability, allows for a rapid response to any safety and quality issues, and avoids unnecessary delays in regulatory procedures.
Consequences of Not Sharing Updated Documentation
Not having the correct documentation at the necessary time can lead to serious problems, such as:
Delays in the management of new registrations, modifications, or extensions of medical devices with COFEPRIS.
Obstacles in the authorization of procedures with COFEPRIS.
Risk of regulatory non-compliance, which can result in sanctions, fines, or suspension of activities.
A Joint Effort to Strengthen Tecnovigilance
Collaboration between distributors and registration holders is key to ensuring that medical devices comply with quality and safety regulations. Maintaining updated documentation and sharing it proactively not only facilitates regulatory management but also reinforces trust in the supply chain and protects patient health.
Written By:
Gabriela Pedraza
about ips
At IPS, we understand the critical importance of complying with regulations to ensure the safety and quality of medical devices. If you have any questions or require further guidance to comply with the Notice of Operation or the Registration of the Tecnovigilance Unit, don´t hesitate to contact us at info@insumosparasalud.com. We are here to assist you in navigating the complex regulatory landscape of medical devices in Mexico.