Medical Device Single Audit Program (MDSAP) is a program developed by the International Medical Device Regulators Forum (IMDRF) to streamline the regulatory audit process for medical device manufacturers that sell their products in multiple countries. The program allows manufacturers to undergo a single audit that satisfies the regulatory requirements of participating countries, rather than multiple audits by different regulatory bodies.
MDSAP was designed to benefit both regulatory authorities and medical device manufacturers. For regulatory authorities, the program promotes international harmonization of medical device regulations and standards, allowing them to leverage resources and reduce the burden of conducting multiple audits. For manufacturers, the program simplifies the regulatory audit process, reduces audit costs and time, and increases efficiency.
MDSAP is currently accepted in five countries: the United States, Canada, Brazil, Japan, and Australia. Each regulatory authority has its own regulatory requirements, but MDSAP allows manufacturers to comply with all of them with a single audit. MDSAP audits cover several areas including Quality Management System (QMS), medical device adverse event and advisory notice reporting, corrective and preventive actions (CAPA), design and development, and production and service controls.
The QMS evaluation ensures that the manufacturer's QMS meets regulatory requirements and is effectively implemented. Manufacturers are also required to report adverse events and advisory notices related to their medical devices to regulatory authorities, and MDSAP audits evaluate the manufacturer's processes for identifying and reporting such events. The program also evaluates the manufacturer's processes for identifying, documenting, and implementing corrective and preventive actions.
MDSAP audits evaluate the manufacturer's design and development processes to ensure that they comply with regulatory requirements and are effectively implemented. Additionally, the program evaluates the manufacturer's processes for ensuring that products are produced and serviced according to regulatory requirements and are safe and effective.
MDSAP audits are conducted by auditing organizations that are authorized by the participating regulatory authorities. Manufacturers must select an authorized auditing organization to conduct their MDSAP audit. After the audit is completed, the auditing organization issues a report that is submitted to the regulatory authorities in the participating countries. If the audit is successful, the manufacturer is issued an MDSAP certificate that is recognized by all participating countries.
In summary, MDSAP is a program designed to simplify the regulatory audit process for medical device manufacturers that sell their products in multiple countries. By undergoing a single audit that satisfies the regulatory requirements of multiple countries, manufacturers can reduce audit costs and time, increase efficiency, and promote international harmonization of medical device regulations and standards. Some of the keywords related to MDSAP include medical device single audit program, IMDRF, regulatory audit, medical device regulations, quality management system, adverse event reporting, corrective and preventive actions, design and development, production and service controls, participating countries, auditing organizations, MDSAP certificate, regulatory compliance, international harmonization, medical device manufacturers, regulatory authorities, audit costs, audit efficiency, multiple countries, and regulatory requirements.