September 20, 2017
With the clock ticking on Health Canada's January 2019 deadline for medical device manufacturers to move from the Canadian Medical Device Conformity Assessment System (CMDCAS) to the Medical Device Single Audit Program (MDSAP) there is still a lot to learn about the program. Here are a few of the top questions UL's MDSAP certification experts and auditors are hearing:
- Will the Heath Canada deadline be extended? At the 2017 RAPS Annual Conference, Health Canada was forthright in committing to keeping its deadline. This means companies selling medical devices in Canada need to start planning their transition and get their audits scheduled as soon as possible (ASAP) to be ready by January 1, 2019.
- Can the AO conduct a Mock Audit? Unlike some other certification schemes, under the MDSAP, the Auditing Organization is able to conduct mock audits for its clients. One major thing to note is that the 2016 version of N3 - " Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition" states in clause 9.4.3: Findings from any audit, ("mock audits," "gap audits," or "pre-assessment audits" outside of the scope of Stage 1/Stage 2 audits), shall be documented and taken into consideration when grading nonconformities identified at a subsequent regulatory audit. Audits of manufacturers used as a training audit for Regulatory Authorities, which do not issue any reports or list of findings, are not considered a "mock audit" for purposes of this clause.Therefore your company has to weigh the value of the insights gained from doing a mock audit against the potential additional work of having the mock audits findings followed up on and closed during the actual Stage 1 and Stage 2 audits. If you choose a mock audit, the management team must be fully prepared to address any findings, within their CAPA process, prior to the Stage 1 audit.
- Why did my number of audit days increase under MDSAP? UL MDSAP Lead Auditor addressed this question in our webinar. In the webinar, she also provides links to training and explains the MDSAP AU P0008 document for "Audit Time Calculations." While MDSAP is based on ISO 13485:2016, it also adds in the country specific requirements for all participating countries you are selling the product into. So if you are selling in both Canada and the U.S. then each country specific requirement also needs to be audited. And ISO 13485:2016 is still pretty new to most companies, so it's an upgrade/transition unto itself. Keep in mind that the overall time and resources required to support a single MDSAP audit is still probably less than hosting separate FDA inspection, Brazil ANVISA audit, ISO 13485/CMDCAS, Japan GMP and Australia audits.
UL is a Recognized Auditing Organization under MDSAP. Click here to visit our dedicated MDSAP webpage to learn more and access links to FDA training, white papers and other helpful resources.