Hi Laura,
I could provide you with some information about Consultants in Mexico, to help you with this project.
Some colleagues in our Company have also used EMERGO for this purpose.
In Mexico there is a mandatory norm which requires to have a Tecnovigilance unit, which will take care of Complaints/recalls (to say it summarized). That is also a role for the Distributor you choose.
Another consideration for Mexico... if eventually you may be interested also in manufacture here, a GMP certificate is mandatory by COFEPRIS for all medical devices/pharma manufacturers located in Mexican territory. That is needed at site level, besides the sanitary registration required at product level.
Best regards.
Celia.------------------------------
Celia Encinas
Regulatory Affairs Specialist
Medtronic Mexico
Tijuana, B.C.
Mexico
celia.encinas@medtronic.com------------------------------
Original Message:
Sent: 04-Aug-2017 06:33
From: Sunitha Reddy
Subject: Mexico registration
Hi Laura,
It is mandatory to have an in country regulatory representative for Mexico. However in most of the cases the distributors are not clear about all the responsibilities of the local regulatory rep and try to take this responsibility so as to continue controlling on the market for your device/s. The major focus for distributors is on selling the devices and might not be up to date on the regulatory changes and happening for your products.
Also while you would want to change your supplier/distributor, you would again have to bear the cost for the re-registration. All the technical documents for your devices would be in the name of the current distributor, so when you would want to switch, you will have to get the new manuals, labels and technical documents printed in the new distributors name and also it will create some ambiguity when you have devices with different information when you switch the distributor.
Also in case of any recalls/incidence reporting would the distributor/supplier be able to take the ownership and defend.
Let me know if you would like to get further information on having a regulatory partner for Mexico.
Regards
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Sunitha
Freyr Software Services Pvt Ltd
Princeton NJ, United States/ Hyderabad, India
+91 9100 941 932
Original Message:
Sent: 26-Jul-2017 17:20
From: LAURA HOSHUE
Subject: Mexico registration
Hi colleagues,
We are currently looking into expanding our market share in Mexico. As is required by COFEPRIS, we will need to have a Mexico Registration Holder to facilitate the approval of our devices and act as the liaison between us and COFEPRIS. In any event, to date we simply go through our supplier here who has a distributor of their own in Mexico. The goal in the long run is to go independent of the supplier, having our own MRH and appointing a specific importer/distributor. Does anyone know what is required, costs involved, timing etc.? How difficult or easy is it to appoint another distributor/importer in the long run, and whether it varies per type of device, i.e. medical vs domestic use (small appliances) etc.?
Any feedback would be appreciated.
Regards,
Laura
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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