Easy to understand chart describes the medical device registration process in Mexico for COFEPRIS.

1. Mexico
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2016. EmergoGroup.com/Mexico
In Mexico, medical devices and in-vitro diagnostic (IVD) devices are governed by COFEPRIS,
a division within the Mexican Ministry of Health (Secretaría de Salud).
Determine if your device or IVD is on the COFEPRIS list of deregulated products. If not, determine classification of
your device based on rules found in Criteria for Medical Device Classification published on the COFEPRIS website.
If you have no local presence in Mexico, appoint a Mexico Registration Holder (MRH) as your in-country regulatory representative.
Your MRH manages your device application and controls your medical device/IVD registration in Mexico.
Prepare a detailed Registration Dossier including draft labeling and Instructions for Use.
Provide proof of compliance with quality management requirements
(e.g. ISO 13485 certificate) and/or a CE certificate.
--OR--
If your device is already registered in the US, Canada or Japan, your device may
qualify for an equivalency review process with fewer documentation requirements.*
Depending on your product’s features and intended use, specific test reports could be required.
In general, reports from tests performed outside Mexico according to international standards
are accepted.
MRH submits Registration Dossier to COFEPRIS or Third Party Reviewer** for review,
along with payment for registration fees. All documents must be submitted in Spanish.
Submit application, including
basic company and device
information, to COFEPRIS.
All documents must be
submitted in Spanish.
All devices must follow labeling requirements found in NOM-137-SSA1-2008. Labeling and instructions for use must be in Spanish.
Demonstrate home country approval.* A common way to satisfy this requirement is with a
Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
Class I
Class I
Low Risk
Class II Class III
Designate a qualified distributor to bring your medical device or IVD into Mexico. Your distributor(s) should be specified in your
registration dossier prior to submission to avoid having to modify your registration(s) later.
Certificate issued by COFEPRIS and proof of registration published on COFEPRIS’ website.
Registrations are valid for 5 years. Some products will require an import permit before they may be brought into Mexico.
You may now begin marketing your device in Mexico. Update your reporting procedures to comply with
Mexico Technovigilance requirements found in NOM-240-SSA1-2012.
5038-0716
Regulatory Process for Medical Devices and IVDs
* The “equivalency route” utilizes more summarized documentation. However, despite the name, your time to approval using this process may actually take longer than the standard review process. The equivalency
route is also slower if you need to submit a modification in the future. Submissions leveraging an equivalency route are NOT eligible for Third Party Review. Companies leveraging US equivalency must be able to
provide an Establishment Inspection Report (EIR) or ISO 13485 certificate for each manufacturing site. Companies without home country approval can register under a qualifying equivalency agreement.
** COFEPRIS has authorized certain third party companies to conduct reviews for Class I, II and III devices and “pre-approve” the application. Third Party Review may reduce the review time by up to half, but they
charge an additional fee. Companies using the “equivalency” route cannot submit through a third party reviewer.
This is a simplified overview of the process. COFEPRIS may choose to audit your submission and request more documents, which will add time to your approval.

2. Mexico
Notes
1. The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue,
medicinal substances or employ novel technology. Your length of approval will depend on the quality and completeness of your technical documentation
and how much time you take to address additional information requests from authorities after submission. More than half of all applications are subject to
additional information requests and this can double review times. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
2. Registrations remain valid for 5 years. If you make changes to the device, intended use or indications for use, the registration must be modified but this
will not affect the registration validity date.
3. We recommend starting the renewal process no later than the time period specified above. However, please consult with your distributor or regulatory
expert well before this suggested time to avoid any lapse in your registration.
4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who
were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other
markets are compared.
5. Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, in-country
representation, submission preparation consulting and translation of registration documents.
EmergoGroup.com/Mexico
Device classification
in Mexico 
Class I
Low Risk
Class I Class II Class III
How long you should
expect to wait after
submission until
approval is granted.1
1-3 months
3-6 months
(Third Party Review)
3-6 months
(Third Party Review)
3-6 months
(Third Party Review)
4-10 months
(Standard Review)
4-10 months
(Standard Review)
4-10 months
(Standard Review)
JP - 1-3 months
(Equivalency Review)
JP - 1-3 months
(Equivalency Review)
JP - 1-3 months
(Equivalency Review)
CA - 6-8 months
(Equivalency Review)
CA - 6-8 months
(Equivalency Review)
CA - 6-8 months
(Equivalency Review)
US - 6-8 months
(Equivalency Review)
US - 6-8 months
(Equivalency Review)
US - 6-8 months
(Equivalency Review)
Validity period for
device registrations.2 5 years 5 years 5 years 5 years
Registration renewal
should be started this
far in advance.3
12 months 12 months 12 months 12 months
Complexity of the
registration process
for this classification.4
Overall cost of gaining
regulatory approval.5
5038-0716
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2016.
Time, Cost, and Complexity of Registration
Simple Complex Simple Complex Simple Complex Simple Complex
Low High Low High Low High Low High
This is a simplified overview of the process. COFEPRIS may choose to audit your submission and request more documents, which may add considerable time to your approval.