REGULATORY REQUIREMENTS IN A CONNECTED WORLD
MDSAP, the Medical Device Single Audit Program, was initiated by the International Medical Devices Forum in 2012. It is a single audit performed by an authorized organization to assess a company's compliance with the regulatory requirements of MDSAP member countries. As of this date, the MDSAP member countries are the USA, Canada, Australia, Brazil, and Japan.
MDSAP aligns with the ISO 13485:2016 Medical Device requirements and includes additional country-specific regulations required for the products sold in the US, Australia, Brazil, Canada, and Japan. The certification demonstrates that a company complies with regulatory requirements of the MDSAP participating countries in which it sells products.
The structure and scope of the MDSAP audit are similar to ISO 13485:2016 Medical Device. However, the process areas are Management; Device Marketing Authorization and Facility Registration; Measurement, Analysis, and Improvement; Medical Device Adverse Events and Advisory Notices Reporting; Design and Development; Production and Service Controls and Purchasing.
If your organization is certified to ISO 13495, you will need to determine which QMS procedures and processes need to be updated to comply with the requirements of the MDSAP.