As mentioned in our Classification and Grouping Ultimate Guide, there is a set of rules to classify and group medical devices in Mexico. Those rules are explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM).
We have already reviewed strategies to classify and group orthopedic implants, ultrasound systems and in vitro diagnostics. In this article we will focus on Medical Imaging Equipment.
Medical Equipment general characteristics
Mexican regulations define Medical Equipment as:
“Equipment, accessories and instruments for specific use, intended for medical care, surgery, exploration procedures, diagnosis, treatment, and patient rehabilitation, including equipment for biomedical investigation activities.”
Such definition includes a wide variety of accessories intended to be used alongside or in conjunction with the medical equipment, such as:
- Spare parts
The above-mentioned accessories are often provided by the same manufacturer of the medical equipment and thus need to be included in the Sanitary Registration. However, accessories could be treated as medical devices by themselves and require a separate registration. This is particularly true when the accessory is invasive (e.g. transducer, catheters, needles). A worth regulatory strategy is to include in the same registration, medical devices that have been previously registered. There are some conditions that could be met, but this route is used to save efforts and yet be in compliance.
Classification according to the level of risk
Most medical equipment for imaging by its nature can be classified as noninvasive medical device Class I – Rule 1. Thermography is an example for this classification.
However, if the medical equipment is introduced into the body or it uses ionizing radiation for the imaging function, it can be considered as class II or class III:
- Invasive medical devices (Class II). Rule 5.
- Endoscopies are a representative example for this case.
- Medical devices issuing ionizing radiation (Class III). Rule 10. X-ray imaging is an example for this classification.
- A point to consider is that we have found consistent evidence that X-Rays, CT-Scans are generally classified as Class II. Then, we recommend to review precedence in Mexico to evaluate these cases.
Grouping for Sanitary Registration purposes
Different models of Medical Imaging equipment can be grouped in the same registration, in the meantime they have the same technology, indication of use and intended use.
Medical equipment may need to detect a contrast agent (radiopharmaceutical) by using X-ray, MRI or CT. Those contrast agents are not considered accessories and need a separate sanitary registration.
If you have any question about classification and grouping of medical equipment for imaging, feel free to contact us at firstname.lastname@example.org or check our guidelines.