Medical Device Single Audit Program: What you need to know, Pt. I

Sep 13, 2017 | News

Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market.

With that goal in mind, the International Medical Device Regulators Forum (IMDRF) began work several years ago to create a program framework that would enable the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. The MDSAP was developed by representatives of regulatory authorities including the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA).

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.  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.”

Audits are conducted by auditing organizations authorized by the participating regulatory authorities to audit under MDSAP requirements. All regulatory authorities participating in the MDSAP are equal partners in the program. The auditing organizations are the same Notified Bodies you might have used to obtain ISO 13485 certification and CE Mark authorization.

The program’s goals include:

  • Development of an international coalition to improve medical device safety and oversight on an international scale
  • Creation of a single audit program that provides confidence to international regulators
  • A minimized regulatory burden on the medical device industry
  • Enabling government regulatory authorities to focus on critical/problematic manufacturers, allowing notified bodies to conduct inspections on their behalf
  • More efficient and less burdensome regulatory oversight of medical device manufacturers’ quality management systems
  • More effective use of regulatory resources through work-sharing and mutual acceptance among regulators
  • Better global alignment of regulatory approaches, and technical requirements based on consensus standards and best practices

Part II of this two-part series will cover the MDSAP structure and how the program will address industry concerns about global quality information security in a single audit process program.