MDSAP is being deployed for
five countries, i.e. Canada, the United States, Brazil, Japan and Australia, with Canada really being on the forefront. However, in the rapidly changing regulatory environment, it is hard for manufacturers to remain properly informed. In this interview, René Schings, Quality & Auditing expert, discusses the basics of MDSAP and shares his knowledge and thoughts on this subject matter.
What is the Medical Device Single Audit Program (MDSAP)?
The MDSAP is an audit program which is intended to cover the Quality Management System (QMS) requirements of 5 countries: Canada, US, Brazil, Japan and Australia. Instead of having individual audits or inspections for each of the participating countries, one would just have to have one audit. By doing one audit, one would satisfy all QMS requirements of these countries.
Why was this program started?
This program was started because some of the countries encountered difficulties in performing the audits, e.g. due to resources limitations. Each country has limited number of auditors. The thought of the participating authorities was to share resources with other participating countries by using one audit program against harmonized audit criteria. This would be easier to manage and would save time.
Who should use this program?
For multiple reasons, it might be interesting to sign up for MDSAP. This is because manufacturers will make a switch:
From 5 different auditing organizations to just one.
from multiple individual audits to just 1.
to predictable audit timing.
In some circumstances, this might also save effort, time and cost, but I will come to that later. Furthermore, a Medical Device company selling or wanting to sell products in Canada, are “forced” to use this program because Canada makes it mandatory from the end of 2018 onward. Also for customers active in Brazil, this might be interesting. Historically, it could take up to 2 years for an Anvisa audit to be conducted and, depending on product classification, for a medical devices company to be able to sell its product(s) in Brazil.
What’s the current status of the 5 participating countries?
Canada is the forerunner of all the participating countries, who has been most active and the fastest to embrace the concept of MDSAP. Starting of 2019, Canada will only accept MDSAP audits. Companies who want such an audit or want to sell in Canada, will need to have the MDSAP audit done before that time and get certified before the deadline: 01-01-2019.
The United States, Brazil, Japan and Australia are all “following” Canada in the MDSAP implementation.
How do Notified Bodies prepare themselves for MDSAP?
For European manufacturers, it is very likely that they would want to build on their existing relationship with a Notified Body for MDSAP.
The major Notified Bodies in Europe have obviously anticipated that, joined the MDSAP program and have been actively communicating that the MDSAP is coming. Everybody has brought the information out. I am not sure whether all manufacturers truly grasp the consequences of MDSAP. Some manufacturers do, but others are passively waiting for the others to take the plunge (NOT dissimilar from what we are also seeing with the MDR/IVDR transition).
Notified Bodies have a limited number of auditors who are trained and accredited to do a MDSAP audit. TÜV SÜD was the first to do so, starting October 1, 2017. The starting point for the other Notified Bodies is a little bit different, however, they are all in anticipation for the fact that Canada, at a certain moment, only accepts certificates issued under MDSAP. The other countries have not yet come to that step.
The prediction of the Canadian regulators is that 20% of the Medical Device companies would fall off and 80% will survive.
What are the benefits and who benefits from it?
Manufacturers, which are exposed to multiple individual audits, see the MDSAP as an advantage from effort and financial perspective.
Those in favor of the MDSAP claim that better and/or more predictable inspection will be done (which is true).
Another benefit is that it will be much more transparent. If a company already passed the audit for the US, then the chance is big that the same company will also pass the audit for Brazil if they decide to market their product in this country at some later moment.
The result of an MDSAP will be visible to the authorities of all participating countries. So, make sure that you pass your MDSAP audit! ;-)
Will there be additional requirements and what are the consequences for the manufacturers?
Theoretically, there are no additional requirements because the criteria (against which you audited) have not really changed. They are rather consolidated into one program. E.g. a manufacturer located in Europe, would already be audited against ISO 13485 (and MDD) and any regulatory requirements of the countries he markets its products in. The MDSAP program is also based on ISO 13485 with specific additions from the 5 participating countries. So that’s more or less the same.
However, the way that the audit is being structured and conducted, has consequences. As it is a sum of all 5 country requirements, with more audit time, rigor and detail, the chance for discovering shortcomings could be higher. Then again, because the audit criteria are known (being documented in the so-called MDSAP companion document), this audit is also much easier to prepare for by the manufacturer.
For some small-medium size companies, this is quite a change from the past. Historically, in Europe, the Canadian certificate cost maybe 2 hours extra on-top of the local ISO13485 & MDD certification audit. So, rather limited effort and cost to add such an important market. Rather than these 2 hours, manufacturers would now be looking at something like 6 days with 2 auditors for an MDSAP audit. Just do the math with the hourly rates the Notified Bodies are charging.
What development do you expect to see in the next few years?
Recently, based on feedback from the market, Canada has communicated that it lowers the required audit effort for small and medium-size companies and that more changes are coming.
Similarly, Brazil seems to be changing its regulations to also accept “foreign” ISO13485 certifications instead of Anvisa, albeit under some conditions.
A big challenge is the un-anticipated side-effects (what is really going to happen with such a “disrupted” change?). Like the MDR, it’s a huge change for companies. Manufacturers need to start preparing and the best way is to hire experts who know in detail all those new requirements. At Qserve, it’s our job to be the expert, to be on top on MDSAP, MDR and other regulations. We have a large team with different kinds of expertise areas. We challenge each other, discuss and have internal debates. Together, we have more than 800 years of medical device experience.
I believe that companies, with a small QA team, can hardly keep up with all those changes.
On the other hand, we have people in our team, that have gone through all the trainings and official certifications and we have our auditing background. We do a lot more audits and have seen a lot more companies and can put things into perspective. It does make sense to organize a kick-off with our experts. We can help you to navigate you in the right direction, from where you can take off.
Should you want to read more, this blog might also be an interesting read:
Five reasons to start your MDSAP readiness now!
If you have a specific question, send a mail to firstname.lastname@example.org and we will try to get your question answered in one of the upcoming interviews.