Australia’s TGA recently announced that it is taking up to 150 working days for mandatory application audits of Class III and Active Implant devices. (Application audits are desktop reviews of devices audited by a Notified Body). Notified Bodies are all taking longer and longer to review files, with several of the larger Notified Bodies with backlogs of up to 6 months for accepting a new application for Conformity Assessment review for CE marking. Similarly long delays are reported in Brazil for ANVISA audit and product registration.
The Medical Device Single Audit Program (MDSAP), an initiative of the International Medical Device Regulators Forum (IMDRF) is intended to achieve two primary objectives:
- to reduce the workload of both auditors and manufacturers by reducing the number of audits (that alone is of value to international suppliers who often have to maintain permanent teams to support multiple regulator audit visits.).
- To aid in the cross-border acceptance of audit reports.
In these days of extensive backlogs – the second objective is taking on a new value. MDSAP certification is intended to allow acceptance of an MDSAP audit certificate in lieu of local regulatory audits by all MDSAP program members. Of all the IMDRF regulators, Health Canada has adopted MDSAP most enthusiastically – announcing a transition from the CMDCAS scheme to make MDSAP the primary audit program for Canada. Australia’s TGA, Japan PMDA and Brazil’s ANVISA are also moving to recognise MDSAP certificates for the purpose of local registrations. The US FDA also is piloting acceptance of MDSAP audits in place of routine FDA quality audits.
The idea is that an MDSAP audit is carried out by a local regulator – Japanese manufacturers to be audited by PMDA, Australian by TGA etc. and then the certificate recognised by all MDSAP parties. This means that a local MDSAP audit could be done at lower cost (less or no need for international auditor travel) and the certificate then is good for all MDSAP members – bypassing those pesky evaluation queues.
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