Medical Device Single Audit Program (MDSAP) for Manufacturers

Schedule (all times EST): 2-Day Session between 9:00am - 6:00pm

About the training

MDSAP should be considered as a strategic asset for organizations based globally, if they export or intend to export medical devices to participating countries.

The program allows an MDSAP auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

The program is beyond the pilot program and is now running full speed starting up to replace the normal structure audit.

The countries which are using the MDSAP reports and certificates are Australia, Brazil, Canada, Japan, and the USA.

Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and Republic of Korea’s Ministry of Food and Drug Safety are now Affiliate Members and World Health Organization and European Union are Official Observers to the MDSAP Program.

For program and more information, click here.