WHAT IS MDSAP

Background

Background

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2003. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits.

The participating agencies are

  • Health Canada
  • The Australian Therapeutic Goods Administration (TGA)
  • The Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
  • The Japanese Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
  • The United States Food and Drug Administration (FDA).

From 01 January 2014 to 31 December 2016, the Regulatory Agencies participated in a MDSAP Pilot. On 29 June 2017, a report was generated summarizing the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the Medical Device Single Audit Program. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the 3 years pilot.

Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

Advantage of the program

Advantage of the program

  • Continued accessibility in the Canadian market beyond 2018: Beginning on January 1, 2019, manufacturers must have a MDSAP certificate if they want to maintain or apply medical device licenses.,
  • Save time and money: by gaining access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.
  • Reduce FDA routine inspections: and minimise manufacturing plant and personnel disruptions.
  • Increase speed to market in Brazil: by avoiding the three-year backlog of companies awaiting ANVISA inspection. Alternatively, use MDSAP, which is accepted for initial audits with the exception of certain higher risk devices.
  • Minimize medical device manufacturer disruptions due to multiple regulatory audits
  • Provide predictable audit schedules (agendas with opening and completion dates)
  • Consistent auditing from a single source for multiple regulatory requirements
How does the program works

How does the program works

The MDSAP is based on a three years audit cycle

 

By following the MDSAP Audit Model

  • Audits performed for MDSAP will be conducted in a consistent manner across auditing organisations.
  • Audits will be conducted logically and efficiently, with attention to the interactions between processes.
  • Auditors will be able to determine whether systemic quality management system nonconformities are present.
Program eligibility

Program eligibility

  • Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and will be subject to their quality management system requirements.

  • Manufacturers located anywhere in the world are eligible to participate.

  • Only the MDSAP participating countries will have direct access to the audit reports.

  • Manufacturer’s cannot select which of the 5 regulatory schemes are to be included within the audit scope. All country specific requirements of the manufacturer’s target sale countries must be included. (This applies to the current 5 participating countries only – Australia, Brazil, Canada, US and Japan)

How will the medtech industry be impacted by the program

How will the medtech industry be impacted by the program

There has been significant progress with the Medical Device Single Audit Program. The five RA’s in the MDSAP pilot have made the following statements on how they intend to
utilize MDSAP reports :

Australia  : The Therapeutics Goods Administration TGA uses 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.

Brazil : The Brazilian National Health Surveillance Agency ANVISA utilizes 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.

Canada : Health Canada HC intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Devices Regulations (the Regulations). MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation has begun on January 1, 2017, and will span a period of two years. During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted. Therefore, manufacturers wishing to continue to place product on the market in Canada as of 2019, need to have MDSAP Certification issued by a recognized AO before that date.

United States : U.S. Food and Drug Administration’s Center for Devices and Radiological Health 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, the MDSAP does 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.

Japan : The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both premarket and periodical post-market audit under regulations in Japan.Japan officially joined the pilot in June 2015, and is in the midst of implementing the transition of AOs to include the Japanese requirements.

Who can conduct audit

Who can conduct audit

To qualify under MDSAP, Auditing Organizations (AO) need to be capable of conducting audits/certifications that are acceptable to the RA’s as an alternative to their own GMP/QSR/ISO 13485 routine audits.

The list of the recognized AO is available here.

In accordance with best practices, the MDSAP incorporates a transparent assessment program by Regulatory Authorities who will oversee the compliance of the Auditing Organizations with MDSAP requirements. This program includes a robust plan and schedule for assessing the competence and compliance of MDSAP Auditing Organizations and includes assessments of their head office and critical locations, as well as witnessing the performance of Auditing Organization ́s audits (“witnessed” audits), as part of an ongoing four year recognition cycle.

Useful links:

Useful links

  • Full details of the MDSAP program, including a comprehensive FAQ are available on FDA website at: link
  •  All official MDSAP documents are also available on FDA website at link
  • The International Medical Device Regulators Forum:  link