I thought I would help you challenge my own IAF program
You see, ISO 13485 is also a voluntary program. ISO 9001 is still the Quality system for most of the world, even for medical devices. You may not believe it, but 80% of Chinese industry doesn't have ISO 13485, and at best, they have ISO 9001 (as I was informed by a Taiwan CAB operating in the region).
So I cannot claim very broad acceptance of the IAF program for ISO 13485, and as it is voluntary, and arguably much more expensive than a free local Taiwan GMP, so it isn't going very far in Taiwan for the SMEs anyway.
MDSAP, like the IAF program, will remain voluntary worldwide, because they are expensive. Regulators that make them mandatory may find a terrible loss of access to medical devices, much the same way Canada has suffered under CMDCAS (as many smaller companies bailed on Canada). That is why they have 3000 firms registered compared to 32,000 US firms.
So smaller countries are not going to make any of these programs mandatory. Heck, not even the US is doing it, so why would, say...Singapore?
Europe could leverage the MDSAP to worldwide use, as they are a HUGE economy. The price of Canada's CMDCAS, but 30 times the value. So if Europe made MDSAP mandatory, it could help Canada enormously, but there is another problem. European Certification is a CE cert,
a product cert, and allows any one of thee different approaches for gaining the CE mark, some don't require any QMS at all. So MDSAP isn't a replacement for CE marking, since this is a actually a product certification "audit" hybrid. This is where IMDRF has to make something work with Europe. I am not opposed to MDSAP. I am opposed to things that don't work. MDSAP is not done, and maybe they can make it work. When I wrote the article, it had too many features of the failed programs of the past. So maybe that will steer them to make it work!
The IAF program was designed to be an "off the shelf" global system of accreditation, derived from the (state of regulatory audits, competency, GHTF SG-4 guidance, etc). It was designed to make the ISO 13485 audits fit for regulator use, worldwide, especially in developing nations that can use local AB resources to help them. Industry can opt in, or out of ISO 13485. If regulators choose to recognize MDSAP or IAF or both (like TGA Australia) fine, but will industry use either of them? Surely ISO 13485 is widely used in
the West, but we still have a long way to go in other regions of the world. The AHWP is now moving much more toward use of ISO 13485, especially with their new Guidance on Good Distribution Practices. In Asia, Distributors need more regulating than manufacturers in some countries.