2. We are a Mexican firm, with more than 10 years of experience, whose
objective is to provide reliable solutions to companies that need
regulatory affair services, based on our experience and knowledge.
Generating optimal results in the Health Sector for the national and
international industry.
Values and Philosophy:
• We act with honesty, transparency and integrity, loyalty to our cause,
our convictions and to ourselves.
• We are a community that promotes the personal and professional
growth of all its members.
• We seek to build trust and credibility with every activity we do.
• We develop the capabilities of our people, we convert them into skills in
order to achieve integral growth and contribute to the success of the
organization.
About us
4. § Medical Devices Registration
(Class I, II & III )
§ Technical modifications
§ Administrative modifications
§ Extensions (renewal).
Regulatory Affairs Consulting Mexican Registration HolderTranslations
§ English – Spanish
§ Spanish –English
§ Other languages under request
§ Legal Representation which allows
the manufacturer to maintain
control over their medical device
registration(s) with COFEPRIS instead
of having a local distributor fulfill
this role. As a result, the
manufacturer can add or change
distributors in Mexico at any time.
Our Services
5. We review basic documentation for each
product and determine classification, according
to current Mexican regulation.
Define class
Preparation of the dossier
Define Pathway
Our time frames depend on the quality of documentation
sent by the manufacturer and response times, this is, if all the
required information is complete we can submit in a time
frame of 30 working days.
* Third Authorized Party Reviewing, response time is 15
working days
•The Regular process, for all kind of devices from any country
of origin.
•Low Risk Devices Registration. Only for those considered as
low risk devices.
•The Equivalence Agreement Process. This expedite process
can be used for those medical devices approved by USA-FDA,
Health Canada or Japanese Ministry of Health.
*Third Authorized Party Reviewing if applicable
Process
COFEPRIS Revision
Response times from the Ministry of Health depend
on the chosen pathway.
Registration Holder
Is due when COFEPRIS (MOH) has granted the Health
Registry (fee is per year per registration ).
6. Time frames
Pathway Best case scenario Worst case scenario
Ordinary 6-7 months 10-12 months
Equivalence agreements (FDA and
Health Canada)
4-5 months 8-10 months
Equivalence agreement (Japan) 2-4 month 5 months
Third Authorized Party 2 months 6 months
COFEPRIS Revision
