Home / FAQ
Frequently Asked Questions
Answers to the most common questions about health regulation in Mexico.
What is the health authority in Mexico?
The Federal Commission for Protection against Health Risks (COFEPRIS).
Do medicines, medical devices, and herbal products require a Sanitary Registration from COFEPRIS before commercialization?
Yes.
Do dietary supplements require Sanitary Registration in Mexico?
They do not require Sanitary Registration, but they do require an administrative process before COFEPRIS.
Do cosmetics require Sanitary Registration in Mexico?
They do not require Sanitary Registration, but they are regulated by 2 different government agencies.
How many classifications exist in Mexico for Medical Devices?
Medical devices in Mexico are classified into three classes: Class I (low risk), Class II (medium risk), and Class III (high risk). Note that classification depends on Mexican law, so it may differ from that of the country of origin.
Are product samples required to submit the dossier?
No, the Sanitary Registration is a purely documentary process.
How long does it take to obtain a Sanitary Registration in Mexico?
The estimated time depends on the type of product and its classification.
Once I obtain my Sanitary Registration, can I commercialize my product?
In addition to the Sanitary Registration, import procedures are required.
Can AL-LO MED help with commercialization after I obtain my Sanitary Registration?
Yes, we offer a comprehensive solution tailored to the client’s specific needs.
Can I know if my product has a future in the Mexican market?
Yes, we specialize in market studies and real product value assessments.