Status Report: Health Canada, CMDCAS, US FDA and the MDSAP
On December 4, 2015, Health Canada (HC) confirmed their transition plan for the Medical Device Single Audit Program (MDSAP).
The intentions of the MDSAP are that a single audit, performed by an authorized Auditing Organization (AO), will meet the quality management system (QMS) requirements of multiple regulatory agencies, derived from ISO 13485:2003, and that employing a single audit program will allow the participating countries’ (i.e. Australia, Brazil, Canada, Japan and US) regulatory agencies to “efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements," among other benefits
The MDSAP Pilot program will conclude December 31, 2016, when HC then intends to implement MDSAP as the only vehicle for manufacturers to comply with the QMS requirements of the Canadian Medical Devices Regulations (CMDR). MDSAP will thus replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. This implementation will begin on January 1, 2017, and will span two years, during which HC will accept both CMDCAS and MDSAP certificates, but as of January 1, 2019, only MDSAP certificates will be accepted, and HC has indicated that further details will be released as the transition plan is finalized. Note that HC’s transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485, which is anticipated to be published in early 2016.
HC also noted that all CMDCAS-recognized registrars have been given the opportunity to apply to be authorized MDSAP AOs during the Pilot and have stated their intentions to do so. Manufacturers who have a contract with registrars not yet authorized under MDSAP should contact their registrar and inquire about their expected timeline for approval. To facilitate transition, MDSAP audits may take the place of CMDCAS surveillance audits but certification documents will only be issued once all certification requirements have been met. Manufacturers who plan to market their devices only in Canada are required to comply with the regulatory requirements set out in the CMDR, but compliance with foreign regulatory requirements will not be enforced. However, the CDMCAS QMS certificate will need to be replaced with an MDSAP certificate, which may require the services of another registrar or AO.
On December 21, 2016, the US Food and Drug Administration (FDA) announced that they were terminating the Medical Device ISO Voluntary Audit Report Pilot Program (effective March 31, 2016) in order to participate in the operational phase of the MDSAP. After review of the MDSAP Mid-Pilot Report, FDA announced that it would participate with the other MDSAP regulators in the implementation of the operational phase of the program starting January 1, 2017. According to the FDA, the MDSAP program provides them “better assurances than the ISO 13485:2003 Voluntary Audit Report Submission Pilot because FDA's requirements under 21 CFR 820 or other FDA regulations typically covered during FDA inspections are encompassed within the MDSAP audit model.” As a result of the implementation of the MDSAP program, FDA will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP.
Ken Pilgrim is Director, RA & QA at Emergo's Canadian office.