The pilot phase of the MDSAP has been over for a good two years now and the program is running officially. Since January 1, 2019 market access for medical devices in Canada has only been possible after a successful MDSAP. What knowledge have the seleon RA team and its customers gained during the first two years? We would like to provide you some insight:
MDSAP, what’s that again?
The Medical Device Single Audit Program of the International Medical Device Regulators Forum (IMDRF) – short MDSAP – regulates joint audits in accordance with the QM requirements of (currently) the U.S., Canada, Brazil, Japan and Australia. They are not performed by the authorities of the respective countries, but by selected recognized notified bodies.
What are the parallels and differences to the regular EN ISO 13485 audit?
First, it is essential to note that the MDSAP cannot replace your regular QM-audit according to EN ISO 13485, as Europe does not participate in the MDSAP. However, the requirements of the MDSAP audit correspond in outline to those of the EN ISO 13485, added to the specific QM-requirements of the participating countries. In other words, if you already have a QM-system in accordance to the requirements of all the MDSAP participants, you have finished a great part of the actual work. Yet, if your QM-system only covers parts of the country’s requirements or does not cover them correctly, you will have to check the processes to achieve a successful MDSAP audit. It is important to know that the audit is basically process-oriented and does not work along the chapters of the standard. The more process-oriented your QM-system is, the more advantageous it is for you and your company.
Nevertheless, this is no guarantee for a successful audit. Your MDSAP audit will be performed along the established processes using one product as an example. But what if you have only older products from a period before the implementation of MDSAP? This is not relevant for the process-oriented approach. Worst-case scenario: your older medical devices will be double-checked with the older processes and the core principles of the MDSAP. Therefore, it is worth it to compile a gap analysis, to update the documentation to the current state of art and, once again, to become familiar with the old and new processes.
What knowledge have the seleon regulatory affairs team and its customers gained during the first two years of the pilot phase?
The auditing is performed on one medical device. The selection criteria seem to be the biggest overlap that exists between the participating countries, the risk class and conspicuous observations regarding feedback from the market. In other words, a new product developed according to the “new process” is not likely to be chosen, but rather a so-called potentially risky long-distance runner already available in all countries. In case you only have a small product portfolio, the criteria for the selection are different.
Process-oriented auditing may reveal non-conformities that have not been revealed in previous audits according to ISO 13485 or other QM requirements. In addition, time investment is higher, and the verification of the implementation is more profound. If there are deviations, they are mostly related to the basics of the ISO 13485 and not necessarily to the specific ones of the MDSAP.
Nevertheless, it is important to ensure that the requirements of all participating countries in which the medical devices are already on the market, are implemented and not solely those of a desired target country. In Canada, for example, an MDSAP audit is mandatory, the CMDCAS process has been stopped. Deviations from the MDSAP can quickly become reportable to the respective authorities. Meaning, even if a deviation concerns only one specific country, all five participating countries will be informed. This again can quickly become painful for the audited company, as no one would like to be in the focus of a licensing or supervisory authority.
To prevent this situation, it is recommendable to follow the MDSAP guide when adapting your QM-system and to check conformance with it. The requirements and regulations of the MDSAP participating countries must be implemented and reviewed at the time of the last in-house audit prior to the MDSAP audit. That way you can kill two birds with one stone!
Would you like to familiarize yourself with the MDSAP?
Take a look at the guidance documents and other relevant announcements:
- General information on the current status and further development of the MDSAP
- MDSAP Auditing Organisations
- MDSAP Guidance documents on the FDA home page
- MDSAP Information from Health Canada
Too much paperwork all at once?
Companies such as seleon GmbH have specialized in quality management and regulatory affairs for medical devices. You will receive consulting and support during the implementation of the MDSAP audit as well as with mock audits.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.