Medical Device Single Audit Program (MDSAP)

What is the Medical Device Single Audit Program (MDSAP)?

In 2012, The International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. It was at that point that the concept for the Medical Device Single Audit Program (MDSAP) was introduced.

The program’s main mission is to “...jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” [International Medical Device Regulators Forum Medical Devices Single Audit Program, International Coalition Pilot Program sheet, January 2014]

Over the past 3 years and into 2016, significant progress have been made towards the full realization of the MDSAP program including the MDSAP Pilot Program which started January 1, 2014 and is expected to continue until the end of December 2016.

What are the Basics and Benefits of the Medical Device Single Audit Program (MDSAP)?

The MDSAP program is a comprehensive approach to quality system auditing and includes the development of an international coalition of countries devoted to pooling resources, technology, and services to enhance the safety and oversight of medical devices worldwide. Therefore the MDSAP program will be beneficial to manufacturers of medical devices who are interested in marketing and selling devices in those countries.

Who are the countries participating to the Medical Device Single Audit Program (MDSAP)?

In the context of the Medical Device Single Audit Program (MDSAP), medical device manufacturers’ quality management system can be audited once for potentially five different medical device markets:

The USA The Food and Drug Administration (FDA) The “ U.S. Food and Drug Administration’s Center for Devices and Radiological Health – FDA – will accept the MDSAP Pilot audit reports as a substitute for FDA routine inspections (biennial by policy)..” [Medical Device Single Audit Program Frequently Asked Questions, March 2016] Exclusions: • Inspection for cause or compliance Follow up • 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) • Combined products

Brazil Brazil Agência Nacional de Vigilância Sanitária (ANVISA) “The Brazilian National Health Surveillance Agency – 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 regulatory technical evaluation on these issues.” [Medical Device Single Audit Program Frequently Asked Questions, March 2016] • Pre-market assessment procedures In lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market (RDC 15:2014) • Post-market assessment procedures To renew ANVISA’s GMP Certificate bi-annually, as an alternative to an ANVISA comprehensive inspection.  RESOLUÇÃO - RE Nº 2.347, DE 17 DE AGOSTO DE 2015

Canada Health Canada (HC) “Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for the purpose of obtaining a new (or maintaining an existing) Class II, III or IV medical device license, pursuant to section 32 of the Regulations” [Medical Device Single Audit Program Frequently Asked Questions, Aug 2017] If the pilot phase is successful: MDSAP as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.  Health Canada’s website

Australia The Therapeutics Goods Administration (TGA) “The Therapeutics Goods Administration will be using an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports”  TGA’s website

Japan Japan’s Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals & the Medical Devices Agency (PMDA) Japan is since June 2015 a fully-fledged member of the MDSAP program, and is no longer an observer nation. Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals & the Medical Devices Agency (PMDA) are evaluating the following possibilities: • For manufacturers intending to put medical devices of class II, III or IV on the Japanese market, an MDSAP Pilot audit report might be utilized in a premarket inspection performed by PMDA or registered certification bodies in Japan. • Undergoing an MDSAP Pilot audit may accelerate the Marketing Authorization with fewer burdens. • An MDSAP Pilot audit report might be utilized in periodical post market inspection performed by PMDA or registered certification bodies in Japan. • Undergoing an MDSAP Pilot audit may reduce some burden even for a post market phase.

Is the Medical Device Single Audit Program (MDSAP) mandatory?

The MDSAP program is voluntary and will rely on one single assessment of the manufacturers’ quality management system annually with a full certification cycle of three years. This will greatly reduce the number of regulatory audits and inspections a medical device manufacturer must participate in. The manufacturer will be able to choose an MDSAP recognized auditing organization. The goal of the single assessment will be to show compliance with the requirements of the five participating countries. Each country defines how the MDSAP results are implemented according to its legislation. After the MDSAP assessment the results (audit report) will be uploaded into a database that will be accessible by participating regulatory authorities.

If MDSAP becomes mandatory for one or more participating countries will manufacturers be expected to be compliant with regulations in a jurisdiction that it does not market?

The manufacturers are expected to be compliant only with the regulations for the jurisdictions where their products are marketed.
[Medical Device Single Audit Program Frequently Asked Questions, March 2016]

What is the link between the MDSAP Audit Criteria and ISO 13485?

The audit criteria of the MDSAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities. In addition, other requirements will be included in the program such as specific requirements of each regulatory authority for product(s) and company registration(s), licensing requirements and any particular requirements related to the reporting of adverse events.
One important provision includes the ability for a manufacturer to exclude the requirements of any jurisdiction in which the manufacturer does not intend to supply medical devices. This means that at a minimum the requirements of ISO 13485 will be included in the MDSAP auditing criteria along with only the applicable regulations of the authorities in which the company intends to sell a device.

Is the CE marking certification included in the outcome of a successful MDSAP Pilot audit?

The European Union is not an implementing member of this program. However, some EU representatives are observers of the MDSAP pilot phase.

What is the future of the ISO 13485:2003 voluntary audit reports in the context of the Medical Device Single Audit Program (MDSAP)?

On February 11, 2016, the Food and Drug Administration (FDA) announced its decision that effective March 31, 2016; they will no longer accept ISO 13485:2003 voluntary audit reports with an audit end date of April 1, 2016 or later. The Food and Drug Administration (FDA) will continue to accept these audit reports with audit end dates of March 31, 2016 or earlier; however, reports must be submitted within 90 days following the conclusion of the audit.
After March 31, 2016, MDSAP will be the primary means for a medical device manufacturer that markets its devices in the United States to participate in a Third Party Audit program. Under MDSAP, the Food and Drug Administration (FDA) will accept MDSAP audit reports as a substitute for routine inspections.

How can GMED assist you with the Medical Device Single Audit Program (MDSAP)?

GMED applied to be part of the MDSAP program, and is an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is one of 10 organizations recognized to conduct MDSAP Audits. As we continue to move forward though the pilot program, we are able to keep our clients up to date on any changes, requirements and critical timelines that may impact your transition to the MDSAP program.

List of Auditing Organization Availability to Conduct MDSAP Audits

 If you are interested in the MDSAP Audit Program with GMED, Contact us.