One audit, five markets: Opportunities of the Medical Device Single Audit Program (MDSAP)
Successful participation in the Medical Device Single Audit Program, MDSAP for short, is desirable for many manufacturers of medical devices. And rightly so, because one of the advantages of the MDSAP is that the conformity of quality management systems (e.g. ISO 13485 or 21 CFR part 820) can be demonstrated for the countries participating in the MDSAP with only one audit. This means that manufacturers can also achieve accelerated market access.
But for manufacturers, there are other arguments in favour of participating in the MDSAP. What are these? We present them to you.
What is the purpose of the Medical Device Single Audit Program?
As the title of the text suggests, the audit programme can provide simplified access to five global target markets for medical devices with just one certificate. Australia, Brazil, Canada, Japan and the USA – all these countries are part of the MDSAP. The EU is currently limited to an observational role. Nevertheless, EU manufacturers can use the audit programme to their advantage.
The aim and purpose of the MDSAP is to reduce costs for manufacturers of medical devices and in vitro diagnostics by reducing the number of different audits and reviews of the quality management system (QMS). In addition, the standardisation of normative and regulatory requirements is to be created by the programme. The same applies to the auditors’ assessment specifications – because uniformity is the primary goal.
However, the MDSAP does not only bring advantages for manufacturers. The programme forces the different authorities to communicate more with each other. This also makes it possible to share audit results and expose fraudsters more easily.
Advantages at a glance
Good to know: Another advantage?
The following applies to the target countries of the MDSAP: Both the national regulatory peculiarities of the different countries and the requirements of ISO 13485 are covered by the MDSAP. However, manufacturers who wish to have a medical device approved on the European market must continue to strive for an MDR certificate.
How does the MDSAP audit work and what are the requirements?
The audits are carried out at four-year intervals by auditing organisations, but confirmed annually by surveillance audits. These are authorised by the authorities of the five participating countries.
In principle, the requirements of the programme are based on ISO 13485:2016, on which the efficiency and conformity of the QMS is checked. In addition, there are the requirements of the participating countries that are not covered by the standard. If a manufacturer does not aim for a target market, the requirements applicable here do not have to be met – naturally with the consequence of losing the certificate for this country.
By the way: We are MDSAP certified
Our joint project with Cimon Medical – the Neodoppler Ultrasound System – has been certified by TÜV Süd as an auditing organisation according to ISO 13485:2016 MDSAP. This means that the medical device for measuring cerebral blood flow in premature infants has achieved the QMS requirements in all MDSAP countries.
Are you also aiming for MDSAP certification with your project? Then simply contact us. We will be happy to advise you on your options.