by UL Compliance to Performance
The Medical Device Single Audit Program (MDSAP) was developed by International Medical Device Regulators Forum to provide an annual audit program with a global approach to auditing and monitoring the manufacture of Medical Devices that would be accepted by multiple International Regulatory Agencies. Objectives for the audit program as listed in the January 2014 MDSAP Pilot Announcement were:
- To operate a single audit program that provides confidence in program outcomes.
- To enable the appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry without compromising public health.
- To promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority.
- To promote, in the longer term, greater alignment of regulatory approaches and technical requirements globally based on international standards and best practices.
- To promote consistency, predictability and transparency of regulatory programs by standardizing: a. oversight practices and procedures of participating regulators over third party auditing organizations, and b. practices and procedures of participating third party auditing organizations.
- To leverage, where appropriate, existing conformity assessment structures.
MDSAP was piloted from January 1, 2014 to December 31, 2016. An international coalition of countries participated in the pilot with 45 manufacturers volunteering to participate by mid-2015. Auditing Organizations were limited during the pilot to accredited organizations or registrars currently recognized by the Health Canada CMDCAS Program. The MDSAP Mid-Pilot Status Report indicated that pilot accelerated project plan evaluation metrics had been met and that MDSAP was a viable audit program.
Manufacturers who participated in the pilot stated that MDSAP reduced the number of audits, reduced internal audit costs and minimized business disruption.
On December 17, 2015 FDA stated that it would participate in the implementation of the operational phase of MDSAP and further stated:
The MDSAP program provides FDA better assurances than the ISO 13485:2003 Voluntary Audit Report Submission Pilot because FDA’s requirements under 21 CFR 820 or other FDA regulations typically covered during FDA inspections are encompassed within the MDSAP audit model.
On September 8, 2016 the MDSAP Regulatory Authority Council announced that additional medical device manufacturers were now able to participate in MDSAP.
On September 29, 2016 FDA officially recognized MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIRs).
On November 29, 2016 the MDSAP Regulatory Authority Council announced that additional Auditing Organizations were now able to apply for participation in MDSAP. Documentation related to MDSAP is available at www.fda.gov.
For the full article from our Medical Device Communiqué, click here.