My previous employer sells blood typing kits to many countries around the world and we were audited by several bodies. Before starting MDSAP, we were audited separately by the FDA, LRQA (for ISO certification), Brazil's FDA, CFIA, Korean FDA, and many more.
It was interesting to see that for the most part they wanted the same thing: safety and reliability of products and records - GDP. Switching to MDSAP was great for us because it meant that we did not have to be periodically audited by 5 different bodies which meant a much lower certification cost.
Each time you go through an audit, the company has to pay the auditing body. In addition to this cost, they have to have enough employees to cover the day-to-day operations while supporting the audit. Reducing this to 1 occurrence versus 5 means a significantly lower cost.
What are some pros and cons you can see in things like MDSAP?
Advantages:
- majority of interruptions for inspection activities no longer occur
-so regulatory staff are not constantly forced to prepare for numerous and varying inspections or audits resulting in a reduction of personnel supporting inspections being drawn away from their assigned tasks less, and impact to the organization’s activities and schedules.
Disadvantages:
-regulatory bodies still may conduct unannounced inspections based on issues they may have detected (recalls, vigilance issues, or significant complaints).
- AOs are required by MDSAP requirements to conduct unannounced manufacturer audits, or special audits when a manufacturer wants to expand its scope of certification.
-There have been situations where manufacturers maintain staff just to support inspections and audits, which is unproductive, but in some situations, may be necessary due to the product development activities taking place (PMA), number of markets, and the enforcement activities.
- Regulatory organizations like the EU require surprise audits, which only adds to the burden and stress of these activities on the organization.
Source:
Maier, R. K., Menon, D., & Stafinski, T. (2018). The Medical Devices Special Access Program in Canada: A Scoping Study. Healthcare Policy, 13(3), 40.
In addition to the poster above - there may be changes in regulations when transitioning to MDSAP. Because the program is now including at least 5 different regulatory organizations that all have different standards, the audit under MDSAP may be more stringent, or there can be changes made that the company is not aware of. These can cause complications during the audit process, even leading to a non-conformity which can be a headache to deal with (but valid). It can lead to companies having to change their processes in order to comply with an MDSAP audit. I feel that there are more pros than cons however, as mentioned before the cost of an audit comes down dramatically and the preparation for an MDSAP audit is much more manageable than before (having to only prepare for one big audit rather than 5 separate ones).
My previous employer sells blood typing kits to many countries around the world and we were audited by several bodies. Before starting MDSAP, we were audited separately by the FDA, LRQA (for ISO certification), Brazil's FDA, CFIA, Korean FDA, and many more.
It was interesting to see that for the most part they wanted the same thing: safety and reliability of products and records - GDP. Switching to MDSAP was great for us because it meant that we did not have to be periodically audited by 5 different bodies which meant a much lower certification cost.
Each time you go through an audit, the company has to pay the auditing body. In addition to this cost, they have to have enough employees to cover the day-to-day operations while supporting the audit. Reducing this to 1 occurrence versus 5 means a significantly lower cost.
What are some pros and cons you can see in things like MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a quality management system to satisfy the requirements of multiple jurisdictions. Some advantages are that the inspection process is a lot faster and easier. This not only makes it easier for the staff inspecting the audits but also for the organizations. Some disadvantages would be that regulatory bodies still have the power to conduct unannounced inspections, which can throw off the organizations and cause recalls and further investigations, hurting the scheduled timeline. Overall, regulatory audits are mandatory for organizations and are required for safety in general.
I think MDSAP is a great way to standardize the auditing process and prepare companies to sell their devices to a wider, worldwide market. Currently 5 countries are part of the program: The United States, Canada, Brazil, Japan, and Australia. A large chunk of the global population is covered by these 5 countries, which would highly incentivize a medical device manufacturer to undergo an MDSAP audit in order to gain access to these markets. However, this also means undergoing an MDSAP audit is high risk, high reward. A successful audit opens up the opportunity to sell the medical device in all of these countries. But if the auditing organization determines that the requirements of one country have not been met, it could jeopardize the ability to sell in the other 4 countries as well. Overall I don't think a more stringent auditing process is a bad thing though if it better guarantees the safety and efficacy of a medical device.
MDSAP stands for the Medical Device Single Audit Program and it is for the conduct of a single regulatory audit of a medical device manufacturer's QMS that satisfies the requirements of multiple regulatory jurisdictions. The dialogue in this post has been very informative and one great advantage (pro) that I saw was that a single audit means fewer interferences, however, MDSAP could come with unexpected inspections and some markets allow surprise audits which can be seen as disadvantages (cons).
MDSAP has its benefits and disadvantages that the other users described above. I won't be going into that since most of it will be a repeat of what they said. What I would like to address is a typical company's 'disdain' for complex or multiple auditing bodies. I generally believe that all companies have some sense of good-will or humanistic goal of leaving the world a better place. But in order to pursue that, there are sacrifices that have to be made, in this case being constant auditing and verification by these regulatory bodies. I understand that it is a costly procedure that can impact the bottom line, but what is more important is making sure that the company is legitimate by law, which in turn means the product would be too.
In my previous job, I worked at an international medical device company that would have North American and Eurasian auditing bodies come frequent to regulate and audit their records and details. Although it would take away workers from their assignments to make them availiable for the audit, it did provide them with experience in working with multiple regulating bodies, and also allowed them to appease multiple auditing bodies without having to delay production if one of said auditing bodies did not grant approval.
