Medical Device Product Registration and Approval
MEDICAL DEVICE REGULATION IN MEXICO
Medical Device is regulated by The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health in Mexico. Its primary objective is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, that provides unity and homogeneity to the policies which are determined.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN MEXICO
Medical devices are classified into 3 categories namely class I, II, and III (I being the lowest risk and III being the highest risk).
The registration requirements are similar to the European Union(EU) with the main focus being on documents from the technical file. An expedited registration route applies if the device has been approved in US or Canada.
LATIN AMERICA REP
Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
Acting as a first point of contact with Regulatory authorities and import/customs offices
Being responsible for pre-certification and post-approval inquiries
Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor