MDSAP cost per jurisdiction

[snoopy2017]

Hello everyone,

How much does an MDSAP audit cost approximately? How much more does it cost for each additional jurisdiction to be audited? Say, a company wants to market in Canada, US, Japan and Australia. How much more does it cost to audit the 4 jurisdictions compared to just doing Canada and US?

If you could clarify, thank you.

 

[yodon]

I've heard wildly varying costs. For a 10-person company, I've seen $30K and heard up to $50k. (I think the $30K was for all jurisdictions and don't know the details on the others). I think the only way to know is to get a quote from your registrar. They would be in the best position to tell you your expected cost.

 

[mihzago]

I don't think there isn't that much difference in cost for each jurisdiction. The audit time calculation spreadsheets don't have any adjustments based on included jurisdictions, and all jurisdiction specific requirements seem to be already incorporated into each task. For example, there is an audit task for Device Marketing Authorization and Facility Registration, or Adverse Events and Advisory Notices, so whether you have 1, 2 or 5 countries, it does not change the audit time all that much.

 

[nozzle]

Has anyone in the UK had a quote from their NB?

Our NB have quoted approx. £12500, we are a small company with 60 employees. The way the letter was written was similar to when a builder sends a quote when they clearly don't want the job :mg:

 

[RobertvanBoxtel]

Dear mihzago, you are incorrect in your statement. The calculation sheet on the FDA website requires you to include the amount of applicable regulations under MDA.
Guess what, the total amount of audit days increases.
And: the calculation is task based. Not head count based. Result: if you are to apply under MDSAP for only one regulation (for example Canada), you will be audited for about 6 days. If not more... Independent of whether you are 2 or 200 employees.
Heard several manufacturers indicate that they will drop their Canada licenses - result: Less medical devices available.

 

[mihzago]

so, in your calculation, assuming the same number of tasks (which are dependent on the QMS processes), and the size of the company (there is time reduction for companies under 45 and 15 of 10% and 20% respectively), what is the difference in audit time if you include various jurisdictions?

You said 6 days with Canada only. How much more if you include other countries? Is there a difference in days?

Please read my statement again. I didn't say there is no difference, and I was pretty clear stating that the audit is based on tasks. My claim was that addition/removal of a jurisdiction is insignificant compared to the entire audit duration.

Some manufacturers may be dropping Canada, because so far only Canada requires MDSAP.

 

[Dave-h]

When including all of the costs associated with the audit (auditor travelling time, preparation time, report writing, annual admin fee etc), to have MDSAP for just Canada would cost around £23,000 per year. That is without the Health Canada registration costs.

We'll probably be dropping Canada. Too costly and too burdensome.

 

[matinino]

Dear Nozzle,

Our NB quoted €30k on top of their several thousands for the ISO 13485:2016. And yearly 24k extra after that.
Which is your NB (BSI UK?)

Thanks, Maarten

 

[Edward Reesor]

Please note that Health Canada is interested in receiving information on the cost of MDSAP and how it will affect your business in Canada.

Please send your comments, cost estimates and intentions to Health Canada (and forward this message to your colleagues who are in the same situation).

 

[Mark Meer]

... 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.