So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration...
COFEPRIS Strengthens Ties to Mexican Industry Group, Plans Restructuring
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Mexican medical device market regulator COFEPRIS recently met with CANACINTRA, a major industry trade association, to discuss issues related to the country’s medical device sector. Emergo Group Mexico staff were in attendance.
Among medical device-related issues that came up at the meeting:
- COFEPRIS director Mikel Arriola Andoni strongly recommended greater use of third parties in the Mexico medical device registration and approval process
- Updates to the COFEPRIS list of products that do not qualify as medical devices (in Spanish) are expected later in 2013
- A restructuring of COFEPRIS is planned in which drug and medical device oversight departments will be divided into two separate units to improve the regulator’s response times for both device and pharmaceutical registrations
These developments together indicate a sustained effort by COFEPRIS to make its medical device regulatory process more efficient. Emergo Group will provide further details as we learn them.