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Home | MDSAP – Medical Device Single Audit Program
January 22, 2018

MDSAP – Medical Device Single Audit Program Reduced audit effort for medical device companies

The stated aim of the Medical Device Single Audit Program (MDSAP), which officially took effect in June 2017, is to reduce audit effort for quality management systems (QMS) for authorities as well as for medical device companies. The pharmaceutical industry is also taking similar steps towards more efficient auditing processes with the Mutual Recognition Agreement (MRA) between the USA and the EU.

Thanks to MDSAP, only one QMS audit will be necessary in future instead of many individual ones. These audits are carried out by recognized third party organizations of the International Medical Device Regulators Forum (IMDRF), so-called auditing organizations (AOs). In addition to ISO 13485:2016 (and version :2003 during the transition phase lasting until 2019), the specific requirements of the respective export country will also be considered. The AOs send an audit report to the responsible authorities and also handle non-conformities.

In the event of a positive audit, the AOs issue a certificate valid for one year in all participating countries, which can be extended with a surveillance audit over the next two years. After the two surveillance audits and a re-certification audit will be conducted in the third year.

As a result, additional audits by further authorities which are part of IMDRF will only be necessary in exceptional cases. For medical device manufacturers, this means fewer audits, less audit preparation effort required, and reduced staff expenses. But MDSAP also brings new challenges: not only requirements placed on QMS by ISO 13485, but also compliance with the requirements of multiple MDSAP authorities. Standards for combination products are especially strict. The timeline for processing non-conformities (NC) is also tight. With an NC degree of 4 or higher, medical device manufacturers have 15 days to set up and hand over a migration plan to the corresponding AO. This plan has to be implemented and proof provided for all measures that were carried out within 30 days after the audit ended.

MDSAP – Medical Device Single Audit Program
Currently, the following authorities are involved:
  • USA (FDA)
  • Canada (HC)
  • Brazil (ANVISA)
  • Australia (TGA)
  • Japan (MHLW/PDMA)

Plans have been made to incorporate additional authorities into MDSAP by the end of 2018. The “Prequalification of In Vitro Diagnostics (IVDs)” programs, part of the WHO, and the EU are also official observers of the project. They are available for consultation, but also free to recognize or reject MDSAP decisions.

Mandatory in Canada starting in 2019

While MDSAP is still voluntary in most participating states, MDSAP certification will become mandatory in Canada effective January 1, 2019. For European medical device manufacturers that export to Canada, this means that they have to prepare their QMS for the new requirements right away.

Do you need an expert on your side? With experience in over 550 compliance projects, we would be happy to provide you with consultation and support in optimizing your QMS in line with MDSAP requirements. Get in touch with us… 

… or subscribe to our newsletter. In our summer issue of UPDATE (no. 2 | 2018) we will provide a detailed report on challenges and opportunities presented by MDSAP, and give some practical insight into current projects.

Your Contact:

Stewart Spears

Global Head of Business Development

+41 61 717 82 00