The update informs about accepting the MDSAP certificates as Certificates for Good Manufacturing Practices in Mexico.
Update
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS, by its acronym in Spanish) issued a statement on July 17, 2023, informing that to obtain a sanitary license, applicable modifications and renewals of foreign-manufactured products, the results of the MDSAP audits will be recognized, by presenting a current MDSAP certificate, as equivalent to the certificate of Good Manufacturing Practices (GMP) issued by this Sanitary Authority.
Regulatory framework
In accordance with the provisions of Article 133 of the Political Constitution of the United Mexican States, international treaties and agreements are part of the Supreme Law of Mexico. The Treaty between Mexico, the United States, Canada (T-MEC), and the Pacific Alliance stand out among them.
Both are aligned with the provisions of ISO 13485:2016, and the certificate issued under this standard is used to issue sanitary licenses for medical devices.
Effects from the ra update
MDSAP certificates have been taken as equivalent to certificate ISO 13485:2016. With this update, COFEPRIS confirms that these certificates are valid to prove Good Manufacturing Practices.
Written By:
About ips
Our regulatory affairs team helps medical device manufacturers obtain the necessary sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.