Medical Device Single Audit Program: The Basics

Holding Globe in One Hand

Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the MDSAP and why is it important?

A global standard

The medical device market has become increasingly more global, with the FDA estimating that imported medical devices made up 35% of the US market. Because of this, and regulators in other countries needing to conduct oversight of products originating in countries other than their own, a standardized global approach to auditing medical device manufacturers was needed.

Program goals included:

  • 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

Involved Countries

It goes without saying that for MDSAP to be successful multiple countries and their regulatory bodies would need to take part. Currently the five regulatory agencies taking part are Australia’s Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA). Canada will also be transitioning from their Canadian Medical Devices Conformity Assessment System (CMDCAS) to the MDSAP system.

How It Works

MDSAP allows for a recognized Auditing Organization (AO) to conduct a single, standardized regulatory audit on a medical device manufacturer. The five countries listed above will take part in MDSAP regulations. And while Europe does not take part in MDSAP, they may join in the future.

Participants in MDSAP are audited on a three-year cycle. The first, Initial Certification Audit is a complete audit of a medical device manufacturer’s quality management system. The remaining two Surveillance Audits are conducted once a year for the next two years. Once the initial three-year cycle ends, a new cycle begins with a Recertification Audit. It should be noted that other audits such as “for cause” inspections may still occur.

Benefits

In the United States, the FDA will accept a MDSAP audit reports in place of most routine FDA inspections, except for “for cause” or compliance follow-up inspections. Another benefit MDSAP participants will receive are a lower risk profile under FDARA rules.

Additionally, by streamlining the regulatory process with the involvement of a singular regulatory body, medical device manufacturers should find a more uniform process, and less disruption in their business.


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