Multilateral audit initiative launched as a pilot program
During its inaugural meeting on March 1, 2012 International Medical Device Regulators Forum (IMDRF) established a working group coordinated by Kim Trautman, Assoc. Director, International Affairs, FDA, CDRH.
Under the work item “Medical Device Single Audit Program (MDSAP)” the work group developed a standard set of requirements for auditing organizations performing regulatory audits of Medical Device manufacturers’ quality management systems. The documents will be applicable to competent authority auditing groups/inspectorate, as well as third-party organizations that conduct such audits.
The overall objective of the Medical Device Single Audit Program is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer conducted by an MDSAP recognized auditing organization to satisfy the needs of multiple regulatory jurisdictions. MDSAP will not require any changes to country-specific regulations.
Regulators who will participate at the beginning of the pilot phase
Australian Therapeutic Goods Administration (TGA) TGA will use an MDSAP audit report as part of the evidence that is assessed in compliance with Medical Device market authorization requirements, unless the Medical Device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports.
The Brazilian National Health Surveillance Agency ANVISA (Agência Nacional de Vigilância Sanitária) ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support the regulatory technical evaluation on these issues.
Health Canada (HC) Health Canada will use an MDSAP audit as part of their Canadian Medical Device Conformity Assessment System, Program, or CMDCAS certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program as the mechanism to achieve regulatory compliance for the quality management system requirements in Canada.
US Food and Drug Administration, Center for Devices and Radiological Health (CDRH) FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA will not be affected by this program. Moreover, MDSAP will not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval or PMA applications.
In addition, Japan’s Ministry of Health, Labor and Welfare, or MHLW, and their Pharmaceutical and Medical Devices Agency (PMDA) recently became official observers and active participants in the pilot program’s regulatory authority council and as subject matter experts in the different expert groups.
Which auditing organizations can apply to the MDSAP?
During the pilot, auditing organizations applying for the MDSAP will be coming from the registrars currently recognized in the Health Canada CMDCAS program.
Beginning in January 2014, the IMDRF started to accept pilot phase applications from auditing organizations. TÜV SÜD America has already applied in time for recognition as an Auditing Organization under MDSAP.
Manufacuters intending to participate
July 2014 is the target date for manufacturers to start utilizing the program. You as a Medical Device manufacturer are encouraged to participate in the MDSAP pilot program! Please contact us if you are interested.