Mastering the Medical Device Single Audit Program (MDSAP): Your Gateway to Global Market Access

The International Medical Device Regulators Forum (IMDRF) recognizes that a harmonized approach to auditing and monitoring medical-device manufacturing could strengthen safety and oversight worldwide. At its inaugural meeting in Singapore in 2012, the IMDRF created a workgroup to develop documents that would advance a Medical Device Single Audit Program (MDSAP).

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a single regulatory audit of a medical-device manufacturer’s quality-management system that satisfies the requirements of multiple jurisdictions.

Why was the MDSAP developed?

MDSAP was created to support regulatory oversight of manufacturers’ quality-management systems while promoting more efficient use of resources through work-sharing and mutual acceptance among regulators. Over time, it aims to align regulatory approaches and technical requirements with international standards and best practices.

Which Regulatory Authorities participate in MDSAP?

The program was developed by the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All authorities are equal partners.

Which manufacturers are eligible for an MDSAP audit?

Any medical-device manufacturer may participate; however, individual authorities may set exclusion criteria. Manufacturers must contract and pay an MDSAP-recognized auditing organization.

Does MDSAP add new requirements?

No. The MDSAP audit model covers existing requirements from participating authorities and does not impose anything beyond ISO 13485.

What are the potential benefits?

1. Fewer audits and inspections, saving time and resources.
2. Reduced FDA routine inspections and less disruption to facilities and staff.
3. Fewer interruptions from multiple regulatory audits.
4. Predictable audit schedules with fixed start and completion dates.
5. Consistent auditing against multiple regulatory requirements in a single visit.
6. Long-term goal: greater confidence in third-party audits.
7. Some authorities may use MDSAP reports in place of their own inspections when reviewing marketing-authorization applications.
8. Participation may demonstrate a manufacturer’s commitment to quality and compliance.

What are the costs associated with MDSAP audits?

FDA MDSAP overview Harvard Health on device regulation

The cost of an MDSAP audit is set by the commercial agreement between the medical device manufacturer and the recognized MDSAP auditing organization.

COVID-19 Remote Audits

Global COVID-19 quarantine orders and travel restrictions have limited auditing organizations’ ability to perform on-site MDSAP audits.

Remote audits may replace on-site audits only when pandemic-related travel bans or social-distancing requirements prevent auditors from visiting the site.

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Detailed MDSAP information is available in the FDA documentation.

Useful links:

1. MDSAP Assessment Procedures and Forms
2. International Medical Device Regulators Forum
3. MDSAP audits during COVID-19
4. Auditing Organization Availability to Conduct MDSAP Audits
5. MDSAP Regulatory Authority Contact Information

Further reading:

• FDA MDSAP overview