In Mexico, when registering medical devices related to Ionized Radiation Sources, there is a special subset of documents to be presented. The Authorization for the Acquisition and Transfer of Ionized Radiation Sources is one of these requirements.
In this article, we provide a brief overview of this document within the context of the Mexican medical device regulation. In addition, we enlist examples of the medical devices that this authorization is applicable for, and which entities must apply for it.
What is an ionizing radiation source?
An ionizing radiation source is any device or substance that emits ionizing radiation in a quantifiable form. Ionizing radiation is a type of radiation that can damage cells and DNA. It can be harmful to human health and the environment.
Why do I need the Authorization for the Acquisition and Transfer of Ionized Radiation Sources?
This authorization ensures that the devices are properly controlled and used safely.
Who must apply for it?
It must be requested by any importer/distributor or manufacturer located in Mexico who intends to handle Ionizing Radiation Source Medical Devices. It is worth mentioning that this authorization is independent of the warehouse notice that is also a requirement.
How do I get it?
This Authorization is issued by the National Nuclear Safety and Safeguards Commission (CNSNS). It certifies that you have been inspected and approved to acquire (in Mexico or foreign countries) and transfer this type of medical devices (to verified users that have also been approved to operate such devices).
To apply for an authorization, you must submit the necessary documents to the CNSNS.
What are examples of medical devices that need this authorization?
- X-ray radiography systems
- Computed Tomography (CT) scanners
- Single Positron Emission Computed Tomography (SPECT) imaging systems
- Positron Emission Tomography (PET) imaging systems
- Fluoroscopy equipment
Conclusion
The Authorization for the Acquisition and Transfer of Ionizing Radiation Sources is a regulatory requirement in Mexico for medical devices containing ionizing radiation sources. It is applicable for the importers/distributors and manufacturers located in Mexico.
If you would like to know if your medical device would require such authorization, you can feel free to contact us at contact@veraqueconsulting.com for further guidance.
