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.