The Medical Device Single Audit Program (MDSAP) was developed by the FDA and international regulators in order to:
• Implement an alternative to FDA audits and participating international audits for four different medical device markets: Australia, Brazil, Canada, Japan and the United States.
• Provide an “all-in-one “single regulatory audit of a medical device manufacturer’s quality management system in order to satisfy the requirements of multiple regulatory jurisdictions internationally.
• Develop an audit that the FDA will accept (MDSAP audit reports) as a substitute for routine agency inspections, with some exceptions that we’ll discuss later.
The MDSAP is only conducted by the recognized auditing organization. The MDSAP and pilot program are voluntary for manufacturers and are intended to be internationally recognized for those countries authorities who wish to participate.
The MDSAP Pilot program was initiated in 2014, completed in 2016, and will be discussed in detail in this module.