The Medical Device Single Audit Program (MDSAP) Agreement is a program that enables medical device manufacturers to conduct a single audit of their quality management systems (QMS) that meets the regulatory requirements of multiple countries. This agreement is a significant step towards harmonization of medical device regulations globally.
Under the MDSAP Agreement, manufacturers can undergo a single audit of their QMS that satisfies the regulatory requirements of five countries: Australia, Canada, Japan, Brazil, and the United States. By complying with these standards, manufacturers can obtain certification for their devices in all five countries, significantly reducing the time and resources required for certification.
The MDSAP program has several benefits for manufacturers. Firstly, it reduces the cost and time required for compliance, allowing manufacturers to reduce their overall regulatory burden. Secondly, it improves the consistency of regulatory requirements across different regions, which can help to ensure that device safety and efficacy are maintained. Lastly, it provides a single point of contact for manufacturers to address regulatory issues, which can improve communication and reduce regulatory risks.
To participate in the MDSAP program, manufacturers must undergo an audit by an authorized auditing organization. The audit assesses compliance with the regulatory requirements of the participating countries, as well as the International Organization for Standardization (ISO) standard for QMS (ISO 13485).
In summary, the MDSAP Agreement is a significant step towards harmonization of medical device regulations globally. By reducing the cost and time required for compliance, improving consistency of regulatory requirements, and providing a single point of contact for manufacturers, the MDSAP program helps to ensure the safety and efficacy of medical devices. Manufacturers looking to expand their global reach should consider participating in the MDSAP program.