The Medical Device Single Audit Program (MDSAP) represents a significant collaboration in the field of international health regulation, designed to improve the efficiency and effectiveness of the audit process in the medical device industry. This initiative was developed by the International Medical Device Regulators Forum (IMDRF) and aims to simplify the regulatory compliance process for manufacturers globally.

MDSAP allows medical device manufacturers to undergo a single audit of their quality management systems and Good Manufacturing Practices compliance, conducted by an IMDRF-authorized and recognized auditing organization. The results of these audits are accepted by all participating program members (United States, Canada, Australia, Japan, and Brazil) as if the Good Manufacturing Practice certificates were issued by the Ministry of Health, thereby facilitating access to multiple international markets under a unified set of evaluation criteria.

Benefits of MDSAP Membership

Countries participating in MDSAP enjoy several key benefits:

1. Mutual Recognition of Audits: This allows for greater consistency and predictability in audit outcomes, reducing redundancy and regulatory burden for manufacturers.
2. Resource Optimization: Both regulatory authorities and manufacturers can better allocate their resources by avoiding multiple independent audits.
3. Standardization of Standards: The program promotes uniformity in safety and quality standards, raising the overall level of products available in the global market.

Commitments of Participating Regulatory Agencies

By adhering to MDSAP, regulatory agencies commit to:

• Accept and respect the audit reports generated under MDSAP, ensuring effective collaboration and mutual trust among member countries.
• Contribute to the ongoing development and improvement of the program, including regular updates to audit criteria to accommodate technological advances and new regulatory challenges.
• Promote the adoption of global regulatory practices, thereby facilitating a safer and more effective environment for health products worldwide.

Mexico’s Membership in MDSAP

Mexico’s affiliation with MDSAP, confirmed on November 2, 2023, marks an important milestone in its trajectory as a global health regulator. Through COFEPRIS, Mexico has demonstrated its commitment to adopting international standards and strengthening international cooperation to ensure the safety and effectiveness of medical devices. This achievement not only enhances national public health protection but also significantly contributes to global well-being, positioning Mexico as a proactive leader in the harmonization of international health regulation, and favors trade and authorization of new products.

As an affiliated member of MDSAP, COFEPRIS is responsible for recognizing MDSAP audit results through the presentation of a valid MDSAP certificate as equivalent to the Good Manufacturing Practice Certificate issued by this regulatory entity for the purposes of sanitary registration in Mexico. That is, a company that manufactures products in Mexico for sale in this country can present the MDSAP certificate for registration purposes without requiring one issued by COFEPRIS, and this authority will accept it.

Sources:

1. International Medical Device Regulators Forum (IMDRF): Documents and publications related to MDSAP.
2. Federal Commission for the Protection against Sanitary Risks (Cofepris): Official communications on Mexico’s membership in MDSAP and its implications.
3. Specialized publications in health regulation and medical devices: Articles discussing the implementation and benefits of MDSAP.