Medical Device Registration in Mexico

1. Sanitary Registration for
Medical Devices
In Mexico

2. What is aSanitary Registry?
Under the terms of the General Health Law in Mexico
(Article 376), Regulatory approval is a Sanitary
Authorization, with which must drugs, narcotics,
psychotropic substances, or products that contain them;
medical devices, prosthetics, orthotics, functional aids,
diagnostic agents, use dental supplies, surgical supplies,
hygiene and healing products, pesticides and plant
nutrients; must have.

3. What is Medical Device?
A medical device is an instrument, apparatus,
implement, machine, appliance, implant, in vitro
reagent, or other similar or related article, including
components and accessories; used to prevent, diagnose
or replace the operation of any part of the body.

4. REGULATORYAPPROVALFOR
MEDICALDEVICES
In Mexico, any medical device intending to be
manufactured, distributed, sold or used in the country
requires a Health Registry.
The Health Registration applicant must demonstrate
through documented evidence that the product to be
registered is safe, effective and quality.

5. From 2005 the validity of the Sanitary Registry is 5 years
and can be renewed as long as they comply with the
provisions established by the Ministry of Health.
REGULATORYAPPROVALFOR
MEDICALDEVICES

6. WhogivestheSanitaryAuthorizationin
Mexico?
COFEPRIS (FEDERAL COMMISSION FOR PROTECTION
AGAINST HEALTH RISKS) is the institution responsible
for granting Health Records in Mexico.

7. ClassificationofMedicalDevicesaccording
tohealthrisk:
For registration purposes the Ministry of Health classifies
medical devices according to the health risk involved in their
use:
 Class I. Are known in medical practice. Its safety and
efficacy are proven. Not usually enter the body.
 Class II. Are known in medical practice.They may have
variations in the material they are made or concentration.
Generally introduced into the body, but remaining in less
than 30 days.
 Class III.Those which are recently accepted in medical
practice. Are introduced to the body and stay in for more
than 30 days.

8. ¿Who is ISA HEALTH?

9. ISA HEALTH is a legal company incorporated in Mexico.
We are a team of professionals exclusively working to
handle Regulatory Affairs business in United States,
Mexico, Colombia, Brazil and Costa Rica for
manufacturers and dealers of Health regulated products
like: Medical Devices, Medicines, Chemicals, Fertilizers,
Pesticides, Food, Dietary Supplements, between others.

10. ¿ Need to register your medical devices in
Mexico?
We can help you
We have extensive experience in the process of
Registration of products with the health authorities.
We also offer advice on regulatory compliance based on
the Mexican legislation and regulations.
We have four offices located in ArlingtonTennessee
USA, Colombia Bogotá, Monterrey N.L. México and
México D.F.

11. Among other services we advise and handle:
 Sanitary Registration,
 Good Manufacturing Practice Certificates, Free Sale
Certificates,
 Importation Permits,
 Advertise Permissions with COFEPRIS,
 Licenses Renewals, between others.

12. Contact us, we will be glad to assist you.
www.isahealth.com
info@isahealth.com