FDAnews Device Daily Bulletin

Mexico Increases GMP, Postmarket Oversight

Feb. 15, 2013
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Manufacturers of devices distributed in Mexico must comply with ISO 13485 good manufacturing practice criteria, effective in April. Additionally, the Ministry of Health approved a device vigilance system to improve postmarket monitoring, manage adverse event reporting and take corrective steps when necessary to protect public safety. That system also is expected to launch in April.
International Medical Device Regulatory Monitor