MDSAP Certification: A Unified Strategy for Global Medical Device Markets

One Audit, Multiple Markets

The Medical Device Single Audit Program (MDSAP) is revolutionizing how regulatory authorities oversee quality management systems. By allowing a single Auditing Organization (AO) to conduct an audit that satisfies the requirements of up to five major regulatory jurisdictions (FDA, Health Canada, ANVISA, MHLW/PMDA, and TGA), MDSAP significantly reduces the audit burden on manufacturers.

Mandatory vs. Voluntary Participation

While MDSAP is highly advantageous, its adoption varies by country. Currently, Health Canada is the only participating authority that explicitly mandates MDSAP certification for Class II, III, and IV medical devices. For the other jurisdictions, participation is voluntary but offers substantial benefits, such as routine FDA inspections being waived when an MDSAP certificate is held.

How to Prepare Your QMS for MDSAP

MDSAP is built upon the foundation of ISO 13485:2016 but adds country-specific regulatory requirements. Preparing for an audit involves:

• Mapping Country Requirements: Integrating specific clauses like FDA 21 CFR Part 820 or Brazil's RDC 16/2013 into your existing ISO 13485 framework.
• Understanding the Nonconformity Grading System: MDSAP uses a unique 1-to-5 grading system for nonconformities, which dictates the timeline for remediation and reporting to regulatory authorities.
• Mock Audits: Conducting rigorous internal audits modeled directly on the MDSAP Audit Approach document before the AO arrives.