Mexico Medical Device Importing and Servicing

fcowdery

Starting to get Involved
#1
We have recently become aware of a US based customer who has sold one our devices to a practice in Mexico however the device is not currently registered in Mexico.

The Device has been cleared by the FDA as Class II.

The customer in Mexico is requesting we provide service for the device.

My question is: Are we able to provide service for the device in Mexico, even though the device has not been registered through COFEPRIS?
 
Elsmar Forum Sponsor

apuigvert

Involved In Discussions
#2
Are you sure if the device requires registration in Mexico? maybe you should first check the list of products exempt of registration.
 
#3
Hi fcowdery,

I think the best approach is to find out from the customer in Mexico, the conditions under which the device was imported (personal use, research, etc.).
This will help determine your liability and whether or not you are obligated to service the device.

Keep in mind that if the device is used in a medical setting (outside of research or personal use) without a registration, there could be serious consequences for your client.

Post your findings and I will be happy to help.
 
Thread starter Similar threads Forum Replies Date
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
W Determining Medical Device Classification in Mexico Other Medical Device Regulations World-Wide 5
Q Mexico Medical Device Registration - Private Hospital Exemption Other Medical Device Regulations World-Wide 1
pittmatj Mexico - COFEPRIS Medical Device Registration Information Other Medical Device Regulations World-Wide 4
K Medical Device Labeling Requirement in Mexico Other Medical Device Regulations World-Wide 2
C Mexico Medical Device Third Party Reviewer Other Medical Device Regulations World-Wide 2
C Medical Device Regulatory Consultant in Mexico Other Medical Device Regulations World-Wide 3
A How to Obtain Medical Device Approval in Mexico (Free Webinar November 2011) Other Medical Device Regulations World-Wide 3
S Medical Device Regulatory Charts for Brazil and Mexico Other Medical Device Regulations World-Wide 0
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
Ajit Basrur Requirements for Refurbishment of Medical Devices in Mexico 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
N Fast Track for Medical Devices Registration in Mexico that are already CE Marked Other Medical Device Regulations World-Wide 11
S New Equivalence Rules in Mexico for US and Canadian Medical Devices Other Medical Device Regulations World-Wide 9
R Registration of Medical Devices (Surgical Blades) in Mexico ISO 13485:2016 - Medical Device Quality Management Systems 1
K List of Deregulated Devices in Mexico Other Medical Device Regulations World-Wide 2
M DMF Submission in Mexico Document Control Systems, Procedures, Forms and Templates 1
K Classification of IVF/ICSI devices (micromanipulator) in Mexico Other Medical Device Regulations World-Wide 0
D Registration in Mexico - Transfer of Mexican Device Registrations Registrars and Notified Bodies 3
S Mexico: Paths to approval for product that is CE-marked, but not FDA approved? Other Medical Device Regulations World-Wide 2
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
K Certificate of Foreign Government (Distributor in Mexico) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Work at USA or return to Mexico? Career and Occupation Discussions 4
R These countries require ISO/TS16949 or ISO9001 to General Motors Mexico to export? IATF 16949 - Automotive Quality Systems Standard 1
A CONCACAF SOCCER FINAL MEXICO vs USA Coffee Break and Water Cooler Discussions 0
C X-Ray Producing Product Regulations in Mexico, Central America, and South America Other Medical Device Regulations World-Wide 2
E What's your opinion on the regulatory requirements of Mexico? Other Medical Device Regulations World-Wide 3
Marc Nearly 4,500 Stranded on Cruise Ship off the Coast of Mexico World News 13
T Third Party Containment in Mexico Nonconformance and Corrective Action 6
A Mexico is Celebrating 200 years of Independence and 100 of revolution Coffee Break and Water Cooler Discussions 8
J Plastic Heat Sealing Companies in Mexico Manufacturing and Related Processes 1
A If the estimates are correct Mexico could win a future Soccer World Cup Funny Stuff - Jokes and Humour 19
bobdoering You know things are gettting bad: US anti-kidnapping expert kidnapped in Mexico Coffee Break and Water Cooler Discussions 2
W Opening Small Shop in Mexico - Does ISO Still Apply? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Research in Mexico, anyone? US class I (non exempt) 510(K) Dental ISO 13485:2016 - Medical Device Quality Management Systems 1
S Mexico Plant - Remote Location or Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A What is required to export Class I (non exempt) 510(k) approved product to Mexico ISO 13485:2016 - Medical Device Quality Management Systems 3
Marc Candy maker Hershey to cut jobs, send some manufacturing to Mexico World News 0
D What are the Norms of NMX-CC-9001-IMNC-2000 In Mexico? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Sidney Vianna Para nuestros amigos de Mexico - RABQSA in Mexico City ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
T Mexico Job Shop - ISO 9001 Certification Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Auditor Certification Requirements for Registrars - Perry Johnson de Mexico General Auditing Discussions 3
A Looking for Calibration Lab's on Reynosa, Mexico ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JoCam Accessories for medical devices EU Medical Device Regulations 5
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
M Prescription Form - Medical Devices US Food and Drug Administration (FDA) 0
XRAY_3121 Drop Shipping Legend Medical Devices Other Medical Device Related Standards 0

Similar threads

Top Bottom