New COFEPRIS Guidance on Technovigilance Report Submissions
Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance reporting program (link in Spanish) for medical device manufacturers commercialized in the country.
First announced in early 2013, the technovigilance system will support post-market device monitoring and management of adverse event reporting and corrective actions.
Most importantly for manufacturers registered in Mexico, technovigilance reports must cover at least four years of commercialization both in Mexico and in other countries where a device is marketed. Previously, manufacturers had expressed confusion as to whether these reports would be required every five years, which would coincide with COFEPRIS registration renewals. Documentation showing regulatory approval of technovigilance reports will be required for registration renewals.
If, for example, a manufacturer is facing a sanitary registration renewal deadline of January 1, 2016, the following time frame would apply:
- Prepare and submit technovigilance report by May 5, 2015
- Submit registration renewal request by August 4, 2015
- Renewal of sanitary registration approved January 1, 2016
COFEPRIS is accepting comments on the technovigilance guidance through September 30.