... Please send your comments, cost estimates and intentions to Health Canada (and forward this message to your colleagues who are in the same situation).
Second this.
However, realistically I don't know what we expect Health Canada to do at this point. I can think of the following (but all have their problems...):
a) further audit-time reductions
- I doubt if they could do this anymore than they have already. Depending on product line & manufacturing processes, small companies apparently are eligible for up to 35% audit-time reduction. It's still a lot more time than ISO/CMDCAS, but even so, this is no longer the bulk of the cost (see point b below).
b) reducing required administrative costs or barriers-to-entry for auditing organizations
- This is where the most gains could be made if possible. Our AO admitted that 1/2 to 2/3 of the quoted cost is just their administrative fees (so audit-time reductions don't affect). Ideally, it'd be easier for AOs to have MDSAP recognition to encourage competition, and lower prices (as AOs don't have huge costs to compensate for).
c) subsidies for small businesses
- Doubtful. But even if, it would only be for Canadian manufacturers.
d) extension of the deadline
- Possible. As the deadline grows nearer, and if there are still many companies not compliant or exiting the market, this may be their only option. Unfortunately, this would effectively punish those companies that diligently arranged to be compliant by the deadline.
e) revoke the mandate altogether
- This would be my ideal outcome....but realistically I don't see it happening.
In anycase, regardless of whether they can do anything at this point or not,
DO take Edward Reesor's advice, and contact Health Canada to express your concerns. At the very least, it is good to make them aware of how their policies are challenging/hurting the healthcare market in Canada.