Medical Device Single Audit Program

  • Overview
  • Benefits of Certification
  • Why Work With NSF?
  • Experts
  • Certification Process

Attaining Medical Device Single Audit Program (MDSAP) certification is paramount to manufacturer success, as it represents an internationally recognized high standard in demonstrating regulatory compliance to regulatory authorities, users, customers and suppliers within the dynamic international legal landscape. The MDSAP allows recognized Auditing Organizations − such as NSF Health Sciences Certification, LLC under its medical device regulatory certification program − to conduct a single audit of a medical device manufacturer that will satisfy the relevant regulatory requirements of the participating regulatory authorities. These include Australia's Therapeutic Goods Administration (TGA), Brazil's Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and the United States Food and Drug Administration (U.S. FDA).

On January 1, 2017 following a three-year pilot, the MDSAP became fully operational and is gaining strength in the medical device community as more jurisdictional areas, e.g. the European Union and the World Health Organization Prequalification of In Vitro Diagnostics Program, are taking interest. The MDSAP is also being used by major manufacturing companies as an important model in the pathway to compliance.

For more information about the MDSAP services offered through NSF Health Sciences Certification, LLC's medical device regulatory certification program, email mdrc@nsf.org or call +1 202.821.4147.

Benefits of Certification

Medical device manufacturers are able to have a single MDSAP certification audit that comprehensively covers the requirements for a quality management system derived from ISO 13485 and the specific regulatory requirements of all the participating international regulatory authorities. Due to the multitude of audits to which manufacturers are subjected, this translates into a savings of time and money as resources are better utilized and interruptions to manufacturing schedules are minimized.

MDSAP certification allows manufacturers to promote their commitment to quality and regulatory compliance, which can be strategically beneficial for access to markets for current and future sales. Additionally, as the confidence in the reliability of third-party audits grows, it is expected that not only will more Regulatory Authorities become members of the program, but that other Regulatory Authorities will leverage this information to limit the need for their additional audits.

Finally, as of January 1, 2019, MDSAP certification will be mandatory for marketing in Canada as the Canadian Medical Device Conformity Assessment System (CMDCAS) will be sunset, creating greater urgency on manufacturer MDSAP certification before the volume of regulatory audit work increases and creates a potential backlog that could impact manufacturer goals.

Why Work With NSF?

NSF Health Sciences Certification, LLC understands the needs of its customers and is committed to providing the highest quality of service. NSF's medical device regulatory certification program has assembled an internationally recognized staff holding decades of EU notified body, regulatory authority and auditing experience, some of whom were directly involved with developing the MDSAP program requirements. With such expertise and the long-standing relationships in the international medical arena, NSF stays current with the changing regulatory landscape and the utilization of this talent assures manufacturers that their audit according to MDSAP requirements is performed both ethically and comprehensively.

Experts

NSF's internationally recognized medical device regulatory certification experts hold decades of EU notified body, regulatory authority and auditing experience, and some were directly involved with developing the MDSAP program requirements.

Certification Process

NSF Health Sciences Certification, LLC's medical device regulatory certification program operates in Washington, D.C. Schemes under the program include medical device manufacturer compliance to regulatory requirements for the specific jurisdictional areas under MDSAP program, conformity to ISO 13485 and technical competence that covers manufacturing technologies for non-active, active, active implantable and in vitro diagnostic medical devices.

In brief, the MDSAP audit structure is based on a three-year certification cycle beginning with application submission and review, Stage 1 and Stage 2 initial certification audit, technical review, and final certification outlining the scope and criteria under which the audit was performed for regulatory compliance. This is followed by two annual surveillance audits and a recertification audit in the final year. Under the Program, the audit report will be shared with participating Regulatory Authorities. The MDSAP scheme is designed to promote consistency across auditors, Auditing Organizations and manufacturers through a defined, mandatory set of operational processes.

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