Ottawa, October, 2017. With just over one year remaining for all CMDCAS certified medical device companies to get MDSAP registration in order to maintain their Health Canada device licenses, Health Canada has announced an early gift for some smaller companies, and a future gift for all MDSAP companies: a reduction in audit duration and therefore cost.
According to the announcement, medical device companies with the following headcounts should see the following reductions in audit duration:
- 10% reduction in audit time for manufacturers with 45 or fewer employees
- 20% reduction in audit time for manufacturers with 15 or fewer employees
- 20% reduction in MDSAP surveillance and re-certification audits for all manufacturers
So, if the AOs (Auditing Organisations) follow this HC announced streamlining, it likely will mean eventual savings for all MDSAP certified manufacturers, and up to 20% savings over the next 12 months for small manufacturers going through the certification process. Now that you know this, what’s the best way of finding out if you are getting the discount? CRO Group suggests calling your CMDCAS / MDSAP registrar now. What to do if you meet the headcounts but had the full duration MDSAP audit already? That hasn’t been addressed as of yet. Perhaps you can ask your AO for a credit toward your first surveillance – then again, all companies are supposed to get a reduction in MDSAP surveillance, so you may need to negotiate. After all, the AO did give you your money’s worth. It’s just that Health Canada is finally recognising the 2 auditor 4+ day model is not always necessary. Then again, the squeakiest wheel generally gets more lubricant if you know what we mean.
You can review Health Canada’s announcement here or, if you are currently CMDCAS certified, or have a HC Class II-IV device license submission under review, are planning to submit a license application soon or, just to stay in the “MDSAP Loop” and impress your boss, and possibly