The MDSAP has mapped within the audit program as follows:

• Medical device QMS requirements (ISO 13485:2016) and Quality System Regulation (21 CFR Part 820) as well as GMP requirements from the participating countries
• QMS requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
• Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
• Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)

In addition, the Canadian Medical Devices Conformity Assessment System (CMDCAS) will yield to the MDSAP as mandatory for regulatory submission in Canada.

The Australian TGA can accept MDSAP certificates as support of evidence for compliance.

The goal is to provide management visibility to ensure QMS compliance with applicable new or revised regulatory requirements.