The Mexican market is complex and diverse, so it's essential to have a tailored strategy for each product.
IPS is a leading provider of regulatory services for the health industries in Mexico. We help manufacturers and distributors of medical devices, dietary supplements, and cosmetics navigate the complex Mexican regulatory landscape. Contact us today to learn more.
The classification query submitted to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is a crucial step in regulating cosmetic products and dietary supplements.
Importing medical devices into Mexico involves a series of steps regulated by health and customs authorities. Due to their impact on public health, these products must meet specific requirements from their origin through to commercialization. Therefore, proactive planning and specialized advice are essential to avoid setbacks.
COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.