By Stewart Eisenhart, Emergo Group
Mexican medical device market regulator COFEPRIS has recently confiscated 23,000 medical devices due to improper labeling, according to Emergo Group sources in Mexico City.
Specifically, the devices were seized for noncompliance with Mexican labeling norm NOM-137-SSA1-2008 requirements. Violations included:
- Not including sanitary registration numbers in labels
- Failing to comply with storage requirements
- Failing to provide labeling information in Spanish
- Failing to specify expiration dates
These recent COFEPRIS actions illustrate the importance of proper labeling and NOM-137-SSA1-2008 compliance for foreign manufacturers exporting their devices to Mexico. Over the past 19 months, more than one million medical devices have been confiscated by Mexican regulators for various noncompliance issues.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.