ISO 13485 and Class 1 Medical Device - FDA thinking

gramaley said:

TGA has agreed to accept ISO 13485 certificates for regulatory submissions of IVDs, so long as the 13485 cert is issued under the IAF Multilateral Recognition Arrangment.

Google Search TGA and ISO 13485 IAF MLA and you'll see it.

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Thanks for that. I should have been clearer - I meant more than QMS / ISO 13485 certification; I meant the whole conformity assessment of Australia-based manufacturers. The benchmark would be EC NBs and FDA Accredited Persons.

According to the TGA's website their acceptance of ISO 13485 certificates from a certification body that is accredited by a signatory member of the IAF MRA to ISO 13485 (for IVD) is pretty old news.

Cheers,
Ronen.

Its funny that you point this out as "old news", because your right. They were accepting ISO 13485 certs from the IAF MLA for quite awhile, but there was just one problem, the IAF MLA didn't exist for ISO 13485 until October 2013, when the IAF added it as a subscope, but then, none of the IAF would sign up!

So the real news is, NOW, finally, the 35 member Accreditation Bodies of the European accreditation Cooperation did agree to add this to their scope of the IAF MLA.

I am aware that TGA did get an IAF MLA marked ISO 13485 certificate two years ago, but that was impossible, so it was immediately suspected as a fake, and so TGA contacted the IAF and IAF confirmed it was a fake. This is why the ISO database will be so handy. They will have all these certs in the database so even the fake certs can be easily discovered.

gramaley said:

IMDRF isn't open to all countries, so it cannot meet that criteria as being truly international. Ironically, the Asian Harmonization Working Party" appears to far more "international", since AHWP is willing to include any regulatory authority that wants to join, and gives them an equal opportunity to participate. Latin American and Middle Eastern regulators have applied and joined AHWP!

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Of course.

The lower the common denominator, the larger the coverage. IMDRF membership covers top notch regulatory systems. I'm sure that as soon as developing regulatory systems from Asia, the Middle East and Latin America catch up with the IMDRF benchmark, they will be welcome to join (Brazil got on board when the GHTF transformed into IMDRF).

Developing economies would always advocate more open markets and removal of trade barriers, this is no surprise. They have less to lose than the developed, well-established economies / regulatory systems / trade systems of regions like the EC and North America. For instance, there is a long standing MRA between Australia and the EC, covering medical devices; The TGA has an EC NB status, and in turn the TGA accepts EC NBs certificates. The issues begin where the standards are NOT equal or at least close.

Your Swedish example is not a very insightful one. Certificate traceability within the EC system is mostly easy, quick and reliable anyway. I wonder if you can come up with a parallel example for a Chinese manufacturer, certified by a Chinese-based CAB (I don't mean a Chinese branch of a European CAB etc.), accredited by a Chinese (or some other Asian, non-Japanese) AB. This is the real challenge, because countless Chinese suppliers are turned down in places like Australia simply because their certificates can't be trusted!...

Cheers,
Ronen.

gramaley said:

Its funny that you point this out as "old news", because your right. They were accepting ISO 13485 certs from the IAF MLA for quite awhile, but there was just one problem, the IAF MLA didn't exist for ISO 13485 until October 2013, when the IAF added it as a subscope, but then, none of the IAF would sign up!

So the real news is, NOW, finally, the 35 member Accreditation Bodies of the European accreditation Cooperation did agree to add this to their scope of the IAF MLA.

I am aware that TGA did get an IAF MLA marked ISO 13485 certificate two years ago, but that was impossible, so it was immediately suspected as a fake, and so TGA contacted the IAF and IAF confirmed it was a fake. This is why the ISO database will be so handy. They will have all these certs in the database so even the fake certs can be easily discovered.

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Thanks.

I'm not an expert on all this accreditation stuff (and don't even deal with it on a regular basis), so this might be nothing, but I noticed that you keep mentioning "IAF MLA" while the TGA's website calls out "IAF MRA". Is this the same thing? Why would the TGA state in 2011 that they accept certificates based on IAF MRA, when (according to you) it was non-existent before 2013?...

http :// www .tga.gov.au/industry/ivd-ca-sponsor.htm - ACCESS DENIED - BROKEN LINK UNLINKED

It is technically referred to by IAF as MLA Multilateral Recognition Arrangement. I think it looks like MRA, but its not really called that. Its more than an "agreement" its an arrangement of high level surveillance, from the very top of the IAF, by a special assessment team that is managed by the IAF MLA Management Committee. They manage all IAF MLA signatory member surveillance, on behalf of all IAF MLA signatories. The IAF MLA MC report to the IAF MLA Group on how its members are operating, after each assessment is completed. The EA will now subject themselve to regular reviews under this "Arrangement". It is quite an impressive assessment, taking weeks, with a 40 page report that comes out of it covering a huge number of areas that are quite important to assuring credibility of all our QMS certs.


China or Japan are part of this, since both the Chinese National Accreditation Service (CNAS) and Japanese Accreditation Board (JAB) are very active in the IAF MLA. JAB provided me with a co-convener for the ISO 13485 WG.

I work with AHWP members, and they are moving toward ISO 13485 in their new guidance, and they have very little stomach for another "Western scheme" they didn't have a part in. At ISO and IAF, they were stakeholders. CNAS and JAB were both in my working group for the ISO 13485 accreditation development, along with European members, of the NB and Regulatory community (ZLG in Germany).

IMDRF is not an international organization, as defined under WTO terms, which would mean they are open to all, and treat all as equal voices, like ISO, IEC, IAF and ILAC, even AHWP, is far more "International" as they accept regulators from Middle East and Asia.

MDSAP is too early to tell, but if it remains voluntary in the US, as I'm told it will, and voluntary in the Europe as well, why would we sign up? For Brazil? Are you joking. Tarrifs are 30%, that alone keeps our products out of Brazil, so what then, Canada? OK, maybe Canada, we sit on the border with Canada. If your a small company in any other part of the world, your not going to sell into Canada. Canada has only 10% of the registered firms that US FDA has, so that is a warning to what happens when you mandate an expensive program that foreign manufacturers don't care about.

Consider that smaller countries like Brazil and Canada make up less than 1% of sales. How much would you pay to get a piece of pie that is 1/100th the size of the pie. Consequently, these same countries import 90% of their medical devices, so when they isolate themselves by adopting expensive and instrusive programs, they do horrific damage to their healthcare system, such as happened in Canada, which still hasn't recovered from CMDCAS.

Australia was smart, they went right after EFTA and accept CE certs. So industry includes Australia in their big junk of European Pie. MDSAP is not going to be required in Europe or the United States, it will be voluntary, so I'm told, especially in the USA. So they really better take their time and do this right, or they Brazil and Canada are going to get stuck with as being the only two countries mandating MDSAP, and they will only further isolate themselves.

Canada did sign an MRA with Europe, so maybe their is hope for them, if they recognize the CE mark. I don't believe they will abandone their annual licensing fees, so this might be a problem for some manufacturers in Europe. Time will tell.

I am a consultant in a start up company and I would like to clarify if mobility aids or mobile scooter requires ISO 13485 certification in Canada, please? Are there other testing required in Canada before you can sell the product? Thanks!