Regulatory Focus™ > News Articles > New COFEPRIS Guidance on Technovigilance Report Submissions

New COFEPRIS Guidance on Technovigilance Report Submissions

Posted 25 September 2014 | By Stewart Eisenhart

New COFEPRIS Guidance on Technovigilance Report Submissions

Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

 

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 1 January 2016, the following time frame would apply:

  • Prepare and submit technovigilance report by 5 May 2015
  • Submit registration renewal request by 4 August 2015
  • Renewal of sanitary registration approved 1 January 2016

COFEPRIS is accepting comments on the technovigilance guidance through 30 September.


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