Medical Devices Single Audit Program (MDSAP)
Many customers of SGS will have seen in the medical device press the launch of MDSAP: a pilot scheme for joint audits covering the regulations of Australia, Brazil, Canada and USA, with the Japanese MHLW and PMDA as official observers. Links to press releases related to this scheme are shown at the end of this article. This scheme is only a pilot programme for the four regulatory authorities involved but will also be considered as a pilot for joint regulatory audits by the International Medical Device Regulators Forum (IMDRF) and all its members.
Pilot Programme Evaluation
The pilot programme will last three years after which it will be evaluated, changed accordingly and then probably launched as a full-scale scheme for those regulatory authorities that wish to participate. The scheme does not cover the assessment of technical documentation.
In essence, participation by manufacturers in this pilot scheme will fully cover CMDCAS auditing requirements, be considered by TGA as meeting the QMS requirements, and be used by the FDA to replace routine inspections. ANVISA from Brazil have promised to consider the reports but currently there is no legislative framework to formally accept such reports in lieu of an ANVISA inspection.
MDSAP Now Accepting Applications
In 2014, the scheme got underway by accepting applications from current CMDCAS registrars to be approved as MDSAP Auditing Organisations, who can then offer clients MDSAP audits under this pilot. It is the policy of SGS to make such an application.
Pilot Phase Is Voluntary For Manufacturers
The pilot phase is voluntary for manufacturers and it is expected that only those manufacturers already certified under the CMDCAS scheme will consider extending to MDSAP. Manufacturers who apply must submit themselves to be audited against all of the four regulations (Note: exemption is made from regulations in markets where devices are not sold) and should expect the reports to be made available to all four regulatory authorities.
Audits are likely to be 35% to 100% longer than for existing CMDCAS audits. Manufacturers should also be aware that the GHTF five-category system of non-conformities is used, with the close out of the most serious category by unannounced audit.
However, participation in MDSAP may reduce the number of audits, and in particular postpone routine FDA inspections as well as replace a planned CMDCAS audit.
Possibility Of Replacement For 2015 CMDCAS With MDSAP
It is unlikely that SGS will offer MDSAP audits before the end of 2014. If manufacturers wish to replace a scheduled 2015 CMDCAS audit by a MDSAP audit they should contact their local SGS office and register an interest, as this will help us plan our implementation of MDSAP to better reflect our customers’ preferences.
Further Information, Links and References
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