With Kimberly Trautman
Assoc. Director, International Affairs
Office of the Center Director, CDRH
Hi, my name is Kim Trautman and I’m the Associate Director for International Affairs in the Center for Devices and Radiological Health. Today I’m going to talk to you about the IMDRF Medical Device Single Audit Program. The International Medical Device Regulators Forum, or IMDRF, recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices.
The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the Medical Device Single Audit Program, or MDSAP.
This global approach included the development of an international coalition of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in a Pilot Program starting January 2014.
For many reasons not all IMDRF member countries are able to move at this very rapid pace, including changes of medical device legislation, the necessity of country to country confidentiality agreements, and other issues.
This does not diminish the support of IMDRF member countries in the concept and base documents being developed by the IMDRF MDSAP Working Group.
The Pilot International Coalition is an international coalition of countries for the MDSAP Pilot Program. They include:
- The Therapeutics Goods Administration, or TGA, of Australia,
- Brazilia’s Agency, which is known as ANVISA,
- Health Canada, and
- The U.S. Food and Drug Administration.
The MDSAP Statement of Cooperation includes the statement that the heads of the regulatory agencies of Australia, Brazil, Canada and the United States signed a Statement of Cooperation on the MDSAP International Coalition program at the Heads of Agency Summit in Manaus, Brazil in November of 2012.
In addition, Japan’s Ministry of Health, Labour 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.
The mission of the MDSAP International Coalition is to jointly leverage regulatory resources to manage an effective, and efficient and sustainable single audit program focused on the oversight of medical device manufacturers.
Their objectives are including:
operating 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 and industry burdens; 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; also, to leverage, where appropriate, existing conformity assessment structures; to promote, in long 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.
Third Parties and Regulatory Inspectorates are included as part of this program. The development of MDSAP includes the use of third party auditors, much like some current regulatory audit programs, as well as regulatory inspectorates, such as FDA’s or TGA’s inspectorates. Use of third party auditors, in addition to Regulatory Authority Inspectorates, allows greater coverage in auditing manufacturers around the globe.
The government resources can then be focused on high risk or problematic medical devices, manufacturers that are not in compliance with the regulations, and oversight of the third party auditing organizations.
The MDSAP Pilot Audit Process was designed and developed to ensure a single audit will provide sufficient yet thorough coverage of the requirements of medical devices, including quality management system requirements found in ISO 13485:2003; the Brazilian Good Manufacturing Practices, and FDA’s Quality System Regulation, found in 21 CFR Part 820; and other specific requirements of medical device regulatory authorities participating in the Pilot MDSAP program, such as registration, licensing, adverse event reporting and more.
Now how will Regulatory Authorities utilize the Single Audit Program and the resulting audit reports or certificates? Australia’s TGA will use an MDSAP audit report as part of the evidence that is assessed with 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.
Brazil - 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 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 quality management system requirements in Canada.
In the United States, 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, this MDSAP program will not apply to any necessary pre-approval or post approval inspections for the Premarket Approval or PMA applications.
What Auditing Organizations can apply to the MDSAP Program? During the Pilot, the only Auditing Organizations that will be allowed to apply to the MDSAP program will be recognized from the accredited organizations and registrars currently utilized in the Health Canada CMDCAS Program. The list of registrars recognized by Health Canada can be found on the Health Canada website.
As part of the MDSAP application process, the Auditing Organizations will have to comply with the following IMDRF MDSAP documents in addition to other documents approved by the Pilot Coalition Regulatory Authority Council:
First, the IMDRF MDSAP Working Group N3 document – “Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition”.
Second, IMDRF MDSAP Working Group N4 document – “Competency and Training Requirements for Auditing Organizations”.
What oversight will Regulatory Authorities have over the Auditing Organizations? In accordance with best practices, the Regulatory Authorities involved in the Pilot Coalition have developed a robust plan and schedule of assessing the competence and compliance of MDSAP Auditing Organizations to include head offices, assessment witnessed audits, and critical site location assessments on an annual basis as part of a four year recognition process.
The Regulatory Authorities involved in the Pilot Coalition will utilize, as the basis for the recognition and assessment process, the following IMDRF MDSAP documents in addition to other documents drafted and approved by the Pilot Coalition Regulatory Authority Council.
They include the IMDRF MDSAP Working Group N5 document - “Regulatory Authority Assessment Strategy for the Recognition and Monitoring of Medical Device Auditing Organizations”, and the IMDRF MDSAP Working Group N6 document - “Regulatory Authority Assessor Competency and Training Requirements”
In addition, IMDRF MDSAP Working Group N11 document is being produced to “grade” nonconformities of the assessment resulting from Regulatory Authority assessment of Auditing Organizations, and to document the decision process for recognizing an Auditing Organization or revoking recognition. When finalized, this document will also be used under the Regulatory Authority assessment program.
Now how can medical device manufacturers participate? The CMDCAS registrars will be allowed to start submitting their application for MDSAP recognition starting January of 2014. The MDSAP program plan targets the review of applications every six months for the duration of the pilot.
After a successful application review and head office assessment, the MDSAP Auditing Organization applicants will be allowed to perform MDSAP audits for medical device manufacturers that will be utilized by the Regulatory Authorities, as we mentioned above.
How do I find out more about the specifics on these documents, policies, and procedures that will be utilized in the MDSAP Pilot? The MDSAP Pilot will be utilizing the IMDRF MDSAP documents that can be found on www.imdrf.org, and we mentioned those just a bit ago. Also, there are many other MDSAP Regulatory Authority Council reviewed and approved documents for implementing the pilot, to include the audit strategy for auditing medical device manufacturers, such as requirements for the audit reports, audit time calculations, and the whole MDSAP Quality Management System procedures, and many other documents. These documents can be found on the FDA website in the future.
IMDRF MDSAP Pilot Program begins January of 2014 with the application by Auditing Organizations. June 2014 is the target date for manufacturers to start utilizing the program. So please, volunteer to participate! Be part of the process during the pilot to help shape the policies and procedures for the operational program scheduled to begin in 2017. I thank you for your time, and I look forward to your participation.