For a long time GHTF and its successor IMDRF have focused on providing guidance and harmonization. But recently they have moved to the next level of harmonization in practice. The first project is the so-called MDSAP program, the Medical Device Single Audit Program. Manufacturers that sell globally are currently confronted with a growing number of external regulators visiting them more frequently than before, including the different regulatory audits or certificates with respect to the MDSAP markets Australia, Brazil, Canada, Japan and the US. The new program aims to reduce the audit burden on industry, and secondly, tries to reduce the extra efforts needed by each legislator by smartly combining efforts and resources.
Although you might currently well be scheduling your ISO 13485:2016 transition and will certainly be puzzling how to meet the new EU regulations, it is considered best practice to also timely prepare for the MDSAP audit application. Combining the efforts on revisiting your QMS for the above-mentioned purposes with the MDSAP preparation will turn out to be optimal, as most requirements are overlapping. In this blog, I would like to shortly highlight the necessity and the advantages of the MDSAP.
The MDSAP program currently is in a pilot phase, set up by the International Medical Device Regulatory Forum (IMDRF), with the aim to satisfy multiple regulatory authorities with one single audit program. Various well known Notified/Certification Body are at this stage recognized Audit Organizations and are already fully operational in conducting MDSAP audits with fast increasing demand. The core reason for the current boost in applications is the fact that Canada has now announced a definite transition.
Currently, manufacturers need to arrange or be subject to different regulatory audits or certificates with respect to the MDSAP markets Australia, Brazil, Canada, Japan and the US. And the alternative MDSAP audits have not been mandated yet. And so far, only Canada has announced a definite transition. For organizations that sell medical devices in Canada and currently hold an ISO 13485 CMDCAS certificate, Health Canada requires these certificates to be replaced by MDSAP prior to January 1, 2019.
But even when Canada is not one of your key sales markets, there are further advantages of the MDSAP program that should persuade you to start to with these alternative regulatory assessments.
One of the key issues seen currently as downside of the necessary quality system audits from authorities can be their long lead times and hence delays to the subsequent market access. Also hosting multiple regulatory audits, sometimes even at the same time can be daunting. And there might be difficulties in audit preparation, as each legislator takes its own planning and approach. These common issues are certain to change with MDSAP audits performed by your Auditing Organization, as it basically brings you to be in charge and in control of the entire audit scheduling and preparation.
Hence, next to benefits for the regulators, MDSAP has substantial benefits for you as manufacturer, in terms of efficiency, transparency, and harmonization. Enrollment into this program can speed up your market access for the participating jurisdictions. For instance, Brazil requires a quality system inspection before product approval, which might take up to several years to arrange.
Some people have voiced concerns over the burden in the program whilst not selling in all jurisdictions. But it is clearly defined that you do not need to implement all specific regulations for all five markets into your quality system; only country requirements will be included into the audit scope from the jurisdictions where you actively sell your devices.
From a manufacturer’s view, the program allows for aimed preparations that can be taken prior to certification, consistent with the program’s transparency and available information. Such preparations will enhance the compliance of the organization’s quality management system and minimize the risk of negative audit results. The benefit of preparing for the MDSAP audit in parallel to the EU MDR readiness is that it will bring you much closer to regulatory compliance also for Europe, as some of the clear guidance and instructions in MDSAP are consistent with the vaguer requirements as worded in the MDR.
Obviously, transparency has its pitfalls as well, which one should realize when one engages in the program. The MDSAP audits are conducted on behalf of the regulators, and all audit outcome can be reviewed by all five regulators. Consequently, in case of significant concerns reported, a negative audit might be followed up by one or more regulatory responses from the various country regulators. That means that choosing for MDSAP is a positive signature for long term strict regulatory compliance.
Another aspect of recognizing before signing up is that although the overall audit frequency decreases, the costs might somewhat increase, as MDSAP audits are not for free. But that is the price to pay for regaining control over your future.
Looking at the current MDSAP status, it seems to have kicked off quite successfully, and therefore my advice is to sign up on time, rather than running into unexpected problems later.
So, if you have not started already, it might be more than time to consider and plan your transition to MDSAP to ensure the applicable regulatory compliance is seamlessly integrated in your quality management system and audited to safeguard your future business.
Should you wish to discuss our support in planning, preparation, mock audit and/or hosting the audit, you may contact our quality team.