Gary,

TGA accepts CE certificates or CMDCAS certs, or just about anything else.

Europe cannot require MDSAP, as they rely on multiple approaches to CE marking, not only QMS, and need all of the 67 Notified Bodies they are using to sustain their healthcare system.  Sustaining the healthcare infrastructure must not be overlooked.

This is not a truly "single audit program" (one set of audit criteria). The IMDRF statement "Trade is not in our Terms of Reference", accurately reflects their regulators insistence on creating different, NATIONAL audit criteria, which is as follows:

Brazil GMP RDC 16/2013

USA FDA 21 CFR Part 820

Canada SOR 98/282

Japan MO 169

Australia - not really an issue, as they accept CE certs, ISO 13485 certs, if issued by CMDCAS or under the International Accreditation Forums, Multilaral Recognition Arrangement (currently only for IVDs).

Note that Brazil's new RDC 16/2013 was modeled after the FDA QSR structure. So it is very much out of alignment with MO 169 and ISO 13485:2003, CMDCAS and EN ISO 13485 used for CE marking.

All of them have their own national variations as well, so this is why the cost have been reported to be at least 25% higher than CE/CMDCAS ISO 13485 audits.

Why not a "single audit" (single set of criteria).

IMDRF could go further and write their own QMS. After all, isn't that what they all seem to be doing back at their offices? They have the expertise. I appreciate that regulators feel the need to be so involved with assuring that the auditors are qualified, but unless the MDSAP program is wrapped around a single set of audit criteria, it is more costly and burdensome than it should be.

In fact, it likely less to avoid it, except if your a large class III medical device maker selling to Brazil, and here's why...

The CE audit is accepted in Australia. Industry uses ISO 13485 as it is recognized in Australia and as its European cousin (EN ISO 13485:2012). ISO 13485 is also the main focus of the CMDCAS audit, which is what MO 169 is nearly identical to. So with the CE audit, you get Australia straight away, and Canada isn't a big leap in cost, and Japan's reg is also nearly identical.

Furthermore, the FDA QSR is free, and since it only occurs rarely, especially overseas, (where there is only 1 audit about every 20 years), MDSAP is particularly unnecessary for most manufacturers, especially low, to medium low device makers.

Brazil is probably the most troubling country to deal with, on many levels. Tariffs are really high to begin with, so many manufacturers are turned off by that. RDC 16/2013 is only enforced strictly on class 3 devices, and only about 7% of devices fall into that category, so 93% of devices would never be audit against it, so there is no cost issue there either. As RDC 16/2013 is aligned with the FDA QSR, so unless your making class III devices and selling into Brazil, the cost to benefit really aren't going to result in an advantage over sticking to the status quo.

Supporting something that is NOT designed to work right, from the get-go? This makes no sense. And then there is that sticky issue of having all the IMDRF members looking over the audit reports to see if they want to act on their own against the manufacturer. Do manufacturers want to risk getting an warning letter, if the MDSAP audit finds the manufacturer doesn't follow the FDA Quality System requirements well enough? This is also why FDA and Brazil should update their Quality System Regulations. They are out of alignment with ISO 13485 and the other regulated Quality Management Systems

As ISO 13485 is nearly ready to be released in its newest glory, perhaps IMDRF members can make a knock off copy of the QMS, and start making a single set of audit criteria that is aligned with ISO 13485:2014. They are already knocking off some of the Accreditation standards requirement from the ISO 17021, so why not just go the rest of the way, and create their own IMDRF QMS? That is after all, what "Single Audit" was intended to mean.