The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot. Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates.
The pilot ends December 2016 and the formal program begins January 2017.
BSI is a designated AO. We are fully supporting the MDSAP pilot and have been conducting these audits since September 2014. We’ve experienced increased interest and sign ups by manufacturers during 2015 with momentum increasing in 2016. Feedback about the benefits has been overwhelmingly positive.
FDA guidance on MDSAP can be below:
MDSAP Guidance Documents
View a comprehensive explanatory webinar
FDA MDSAP Frequently Asked Questions