Canada announces modifications to the transition to the Medical Device Single Audit Program (MDSAP)

Changes to the transition process are intended to make it easier for manufacturers to switch to MDSAP

The Medical Device Single Audit Programme (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada's decision to replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) and require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the programme. Health Canada expected manufacturers to submit a valid MDSAP certificate to the Medical Devices Bureau by December 31st, 2018.

Health Canada has recognised that that there is often a delay between the timing of the MDSAP audit and the issue of the certificate. In addition, some manufacturers are facing challenges in scheduling MDSAP audits in 2018. As a result, manufacturers might not receive their MDSAP certificates by December 31st, 2018. Health Canada has indicated that they will not take enforcement action against manufacturers who can show that they have undergone an MDSAP audit in 2018 but have not received an MDSAP certificate by December 31, 2018.

To help smooth the transition to MDSAP, Health Canada have also announced that they will allow manufacturers to maintain their existing certification cycles established for CMDCAS. Manufacturers who underwent an initial recertification audit to ISO 13485 under CMDCAS from January 1, 2016 will be allowed to transition into the MDSAP during the process for surveillance audits. Manufacturers who transition to MDSAP during a surveillance audit will not receive an MDSAP certificate in 2018. Manufacturers transitioning to MDSAP during a surveillance audit need to show that they:

• have undergone an initial or recertification audit to ISO 13485 under CMDCAS on or after January 1st, 2016;
• have a valid ISO 13485 certificate issued under CMDCAS that has a validity period to at least December 31st, 2018;
• have an ISO 13485 certificate issued by an accepted auditing organisation with a validity period extending beyond 1 January 2019;
• and have undergone an MDSAP surveillance audit or have made arrangements to undergo an MDSAP audit in 2019.

By 31 December 2018, manufacturers wishing to use the surveillance audit for their transition will need to submit documents to Health Canada including an MDSAP Surveillance Audit Confirmation Notification showing that a MDSAP surveillance audit has taken place in 2018.

The MDSAP Consortium have updated the procedures for calculating the duration of an MDSAP audit. As a result, there could be reductions in audit duration if the manufacturer has 100 or fewer employees, and:

• makes only low risk devices using simple design and manufacturing process, commonly available materials and established technologies, and
• has a history of conformity to ISO 13485 and regulatory requirements.

There is additional material on the BSI website that can help you implement your transition to MDSAP.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.