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.
Health Canada announced on December 4th 2015, the requirement for medical device manufacturers to transition from CMDCAS to MDSAP to place devices into Canada. From January 1, 2019 Health Canada will only accept MDSAP for manufacturers who market their devices in Canada, hence, it is expected that manufacturers will need to transition from ISO 13485 Certification issued by a CMDCAS recognized registrar to MDSAP Certification issued by an AO.
BSI is working towards being a fully recognized AO and is already conducting MDSAP audits.
View the Health Canada announcement for more information.
Independent guidance on the MDSAP program and pilot can be accessed below:
International Medical Device Regulatory Forum (IMDRF) Guidance Documents
MDSAP Guidance Documents