Comisión Nacional para la Protección Contra Riesgos Sanitarios (COFEPRIS)
FAQ
Witch is the Health Authority in Mexico?
Medicine Products, Medical devices and Herbal products require a Marketing Authorization (Registry) in COFEPRIS before commercialization?
Yes
Food supplements require a Marketing Authorization (Registry) in Mexico?
They do not require a Marketing Authorization (Registry) but they require an administrative process in COFEPRIS.
Cosmetics require a Marketing Authorization (Registry) in Mexico?
They do not require a Marketing Authorization (Registry) but they are regulated products in 2 different governmental agencies.
How many classifications exist in Mexico for Medical Devices?
Medical Devices in Mexico are classified in three.
- Class I: Low risk
- Class II: Medium risk
- Class III: High risk
Is important to know that the classification is due to the Mexican laws so it could be different from the country of origin.
I require samples of the product for dossier submission?
No, the Marketing Authorization (Registry) is only documental process.
How much time takes to get a Marketing Authorization (Registry) in Mexico?
The estimated time depends on the type of product you have and the classification.
After I get my Marketing Authorization (Registry) I am ready to commercialize?
In addition of the Marketing Authorization (Registry), import procedures are required.
Al-lo Med can be a solution after I get my Marketing Authorization (Registry) for commercialization?
Yes, we can offer a comprehensive solution fitting in to your specific needs.
Can I know if my product has a future in Mexican market?
Yes, we are specialist in market studies and real value of the products.