What is MDSAP?
MDSAP, known as Medical Device Single Audit Program, is a program that allows a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions. Medical device manufacturers can be audited once for compliance with the standards and regulatory requirements of up to five different medical device markets which include Australia, Brazil, Japan, Canada, and the United States.
The MDSAP audit sequence was designed and developed to allow audits be conducted in a logical and efficient manner. The audit sequence follows a process approach and has four primary processes: (1) Management; (2) Measurement, Analysis and Improvement; (3) Design and Development; (4) Production and Service Controls; and a supporting process, (5) Purchasing. There are also two additional supporting processes: (1) Device Marketing Authorization and Facility Registration and (2) Medical Device Adverse Events and Advisory Notices Reporting; both of these processes are necessary to fulfill specific requirements of participating MDSAP regulatory authorities.
- Single audit optimizes time and resources
- Minimizes medical device manufacturing disruptions due to regulatory audits
- No additional requirements for manufacturers
- Routine audits are scheduled/planned
- Improves predictability, consistency, and transparency with auditing
- Promote greater alignment of regulatory approaches and technical requirements
- The ability to expedite entrance in some markets where traditional regulatory oversight can cause significant inspection and audit delays
How will regulatory authorities utilize MDSAP audit reports?
The MDSAP audit is a significant and reliable tool to promote conformity and consistency across all participants, thus improving the safety and oversight of medical devices. In the United States, the FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. It is noted that, “inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.”
3 Year Audit Schedule
- Initial Certification (Stage 1 and Stage 2)
- Surveillance (Year 1 and 2)
- Re-Audit (Recertification)
Each type of audit will have a varying duration due to the scope and criteria established for each audit. Duration of audit is calculated based on the number of applicable audit tasks associated with the type of audit to be conducted and the specific activities of the organization to be audited. For organizations with 15 or fewer personnel, audit duration may be reduced. If so, audit duration shall not be reduced by more than 10%.
Initial Audit 6-7 days
Surveillance Audit 5-6 days
Re-Audit 6-7 days
What We Can Do For You
AlvaMed is proficient in MDSAP requirements and can help your organization get ready for MDSAP as well as perform mock audits.
For more information: MDSAP Program