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Cons of MDSAP

  • 1.  Cons of MDSAP

    Posted 27-Apr-2017 14:27
    Hello Everyone,

    As we know MDSAP (Medical Device Single Audit Program) is a single audit used in the lieu of the multiple audits by reducing the number of audits and optimizing the time and resources. Is anyone of opinion that MDSAP program can have disadvantages over time?

    Any relevant articles or websites will also do.

    Thank you.

    ------------------------------
    Harsh Raja,
    MSRA candidate,
    Northeastern University,
    Boston MA
    ------------------------------


  • 2.  RE: Cons of MDSAP

    Posted 28-Apr-2017 12:48
    Hi Harsh,

    DITTA offered an excellent seminar on MDSAP, in conjunction with the IMDRF meeting in Vancouver last month. They have posted their content here. My takeaway from the presentations was that it was a new way of auditing (tasks, instead of processes) but that companies who had gone through it, liked it. The tasks require a fixed time, so that can be a disadvantage for companies that previously had shorter audits based on lower headcount. Not very many auditing organizations have been accredited yet, so it can be hard to book an audit. And they strongly encouraged reviewing the audit model and companion documents until they are coffee-stained and dog-eared, in preparation. 

    If you do it, please let us know your experience.
    Best regards
    Karen

    ------------------------------
    Karen Long RAC
    Vancouver BC
    Canada
    ------------------------------



  • 3.  RE: Cons of MDSAP

    Posted 28-Apr-2017 17:51
    I must say, it's rare for me to come across something I can't find a downside too, but I've been thinking about this one, and so far, I'm stumped.  I just don't see a downside to MDSAP. 

    As Karen has noted, there are some challenges to its implementation, but that's true of pretty much anything you implement, and it's undoubtedly going to have some growing pains.  But the fundamental program itself, I just don't see any negatives here, now or in the future.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 4.  RE: Cons of MDSAP

    Posted 30-Apr-2017 13:55
    MDSAP CONS:
    1) Application Process much more detailed than ISO 13485 (including providing Product lists, registration and licence lists, flow charts and approved supplier and significant subcontractor lists)
    2) Audits will be longer, more complex and costly than  standard ISO 13485 audits. - You be having a simultaneous audit to ISO 13485, 21 CFR 820, MO 169 (Japan), ANVISA, Canadian SOR, and Australian Regulations.
    3) MDSAP audits can open the manufacturer's management Review and Internal Audit files to these Competent Authorities.
    4) A finding in product realization section carries 3 points.  If this product has shipped, that's another point. 5 points and all regulatory authorities get a copy of the audit report - and may come in with a "For Cause" audit themselves. 
    5) Internal Auditors need to be MDSAP qualified - that's learning 6 regulations.  These Internal Audits must occur at the locations prior to the external MDSAP audit.
    6) Cost and effort of MDSAP may force many small manufacturer's out of the Canadian Market

    ------------------------------
    Stacey Henning


    United States
    ------------------------------



  • 5.  RE: Cons of MDSAP

    Posted 30-Apr-2017 15:04
    Hello Stacey,

    Those are some great and noteworthy points about the drawbacks of MDSAP. Thank you for sharing them as they cleared most of my doubts I had for the program.

    Thank you.

    ------------------------------
    Harsh Raja
    Boston MA
    United States
    ------------------------------



  • 6.  RE: Cons of MDSAP

    Posted 01-May-2017 09:30
    Hello Stacy,

    You have brought out some very good thoughts in addressing the original question of MDSAP's cons.

    I agree that because of how audit duration is determined that this might not be the right voluntary solution for everyone.  I do believe that some of your points should be more closely examined:
    • To your item 2, this may only be true for smaller manufacturers where their audit duration would be shorter due to their employee count.  Additionally, this would not be the case for any ISO 13485:2016 (due to the increased clarity on including regulatory requirements, and arguably could go for ISO 13485:2003) audit since any of the applicable regulatory requirements in the geographies that would be part of an MDSAP audit should also already be included.  MDSAP has actually made this a little easier and more explicit in its documentation.
    • To your item 4, although this situation sounds punitive, one could argue that making the rating and disposition of nonconformities more explicit beforehand results in less susceptibility to the variability of how the competent authorities could handle each situation differently.  I find that this is less about the audit process than how each manufacturer should be driven to be compliant, hence not so much of a con about MDSAP rather than actually making for a more straightforward knowledge of the responsibilities (and risks) that could be associated with being a medical device manufacturer in those geographies.
    • To your item 5, I'm not sure how would this be different than for any ISO 13495 audit where the internal auditor should be knowledgeable about the applicable regulatory requirements -- of course, they don't need to be competent in any into which that the manufacturer does not sell.  As in my thoughts about your point 2 above, I'd think having this be more explicit in MDSAP actually makes this more straightforward and single source.
    As mentioned earlier, there are still some changes that each manufacturer should consider as to whether it is the right move for them (I'm still unsure of how all of the competent authorities ultimately want to address your point 3), but one point that should be made very clearly now is that with the deadline for Canada coming up, each manufacturer needs to decide and act quickly if they will want to continue to sell there after December 2018.  Avoid the crush by moving forward earlier; I'm not sure MDSAP will be as onerous as one might imagine if the manufacturer is already fairly compliant.  It is mostly a new way of going after what already has been the case, but that's wandering away from the original question.

    Thanks for providing fodder for an interesting dialogue and expanded understanding.

    ------------------------------
    Rem Siekmann
    Principal Engineer
    Mentor OH
    United States
    ------------------------------



  • 7.  RE: Cons of MDSAP

    Posted 01-May-2017 13:34
    I have a couple of other concerns on MDSAP as well. Currently, my small company does business only in the US and Canada. We have our routine NB audits, and, as long as there are no recalls or other signals, FDA shows up every 3 years or so. So now, Health Canada has forced us into this "MDSAP" model, which adds paperwork and complexity, but little to no benefit that I can see. In fact, it adds risk if auditors like some I have seen in the past, who like to nit-pick minutia, now send all that to FDA. We reside in a pretty good FDA district where they seem to focus on the "big things" not little minutia so this will actually be detrimental.

    Second, at least twice in the past I have called my NB and told them not to send back a particular auditor because they added little to no value, just "going through the motions" of the audit. Given that I am paying for these audits, I like to use them to drive improvement in our QS - thus I have had a desire to have auditors who do a diligent job and provide real value. However, with this FDA impact in the picture, I probably will just let the "non-value added" folks alone, which will minimize compliance risks, even though probably hurting the ongoing improvement of our QS. This is because my job is to manage risks for the business, and like it or not, the business risk with respect to FDA (our largest market and that of all my previous companies) is larger than that of any other part of the world - thus minimizing risks there would have to come before "getting the most feedback on our QS" regardless of what the pure quality person in me might like.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
    ------------------------------



  • 8.  RE: Cons of MDSAP

    Posted 01-May-2017 13:45
    Ginger, I'm under the impression that everything about MDSAP is optional.  I understand HC has chosen to make ISO 13485 its QSR-equivalent, but I don't know anything about it forcing anyone into MDSAP.  Could you clarify?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 9.  RE: Cons of MDSAP

    Posted 01-May-2017 15:04
    Please refer to the FAQ published by Health Canada (http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/notice-avis-mdsap-trans-plan-faq-eng.php), where the first FAQ addresses Julie's question about Health Canada mandating MDSAP.

    Q: I received a medical device licence using a CMDCAS certificate. Will my licence be suspended if I don't have a MDSAP certificate on January 1, 2019?
    A: Yes. Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active (meaning a current) medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer's CMDCAS certificate will not be accepted. Additionally, auditing organizations (AOs) will soon begin issuing MDSAP certificates after recertification or special upgrade audits and these are to be submitted to Health Canada using the Form F202 notification process.





  • 10.  RE: Cons of MDSAP

    Posted 01-May-2017 17:13
    John, thanks.  In Vancouver, more than one person with HC told me that HC had adopted ISO 13485 as its QSR-equivalent.  One of them didn't just tell me, but, as you probably know, they told everybody in the room in response to my question.  Is this not true?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 11.  RE: Cons of MDSAP

    Posted 01-May-2017 15:05
    Health Canada will be replacing CMDCAS with MDSAP in January 1, 2017, hence, if a manufacturer wants to sell into Canada after that date, MDSAP won't be optional.

    ------------------------------
    Rem Siekmann
    Principal Engineer
    Mentor OH
    United States
    ------------------------------



  • 12.  RE: Cons of MDSAP

    Posted 01-May-2017 17:09
    OK, but...more than one person with HC told me that HC has adopted ISO 13485 as its QSR-equivalent.  Is this not true?

    Regardless, I'm not clear on the difference in actual practice, except that the auditors will be contracted by the manufacturer, rather than employed by HC (if they ever were).  If HC's requirements are the ISO 13485 requirements, and the only audit you want is for Health Canada, then you request the one audit and pay for the one audit, just as you would have if you requested and paid for one audit for ISO 13485 certification.  (Seems to me, but I'm happy to be informed otherwise.)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 13.  RE: Cons of MDSAP

    Posted 02-May-2017 08:12
    Hi Julie,

    What you were told in Vancouver was accurate.  Actually HC had effectively adopted ISO 13485 as its QSR-equivalent under CMDCAS where a third party auditor (or "registrar") would audit a manufacturer's quality system to ISO 13485 but then add HC requirements along with the audit.  Certificates were issued as "ISO 13485 under CMDCAS", so you are also correct in that the situation under MDSAP is very similar.

    The main differences are those comparing the previous process to the new MDSAP system, including (to name a few):
    • determining audit duration is now based on the number of MDSAP-related tasks audited (vs. employee count),
    • the way non-conformities are rated and handled (now done using GHTF/SG3/N19 vs. "major/minor", etc.),
    • how the audit reports are created, to whom they are sent and potential Regulatory Authority responses.
    These set up the questions that each manufacturer needs to answer, ideally using guidance provided within MDSAP or other knowledgeable resources.  The other challenge is that there are currently a very limited number of Auditing Organizations currently doing MDSAP audits (FDA has a link at: Medical Device Single Audit Program (MDSAP)) and they are also handling the transition to ISO 13485:2016 (also becoming mandatory in 2019) and the EU MDR (becoming mandatory in 2020) which will make access to their resources ever more challenging.  Message there: address this issue in the next several months or face the increasing risk of getting caught without a MDSAP certificate before January 2019.

    Although I am an advocate of what has been done by the IMDRF with MDSAP, answering these questions under each situation will be very individual as to the eventual "pros" and "cons", but for anyone wanting to sell medical devices into Canada after December 2018, the option of using a ISO 13485 under CMDCAS certificate will be removed.

    ------------------------------
    Rem Siekmann
    Principal Engineer
    Mentor OH
    United States
    ------------------------------



  • 14.  RE: Cons of MDSAP

    Posted 02-May-2017 10:17
    Thanks, Rem.  This is very helpful. I think now I'm starting to sort out what I'm confused about.  And what others are confused about that has confused me, lol.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 15.  RE: Cons of MDSAP

    Posted 02-May-2017 22:30
    Among the companies represented at Vancouver, there seemed to be a strong consensus that the program would move forward faster if the exiting AOs increased there qualified auditing staff, rather than by qualifying more AOs.  That's probably true, but that's limited by the resources available to the AOs,* and the IMDRF can't do anything about that.  So IMDRF's priority is still to qualify more AOs, which it can do.


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 16.  RE: Cons of MDSAP

    Posted 02-May-2017 09:53
    I'm pretty sure you meant to type 2019 here, as you did in your more detailed response, rather than 2017.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 17.  RE: Cons of MDSAP

    Posted 02-May-2017 12:56
    Agreed.  Silly fat finger.  Thanks for the catch -- always want to be as accurate as possible.

    ------------------------------
    Rem Siekmann
    Principal Engineer
    Mentor OH
    United States
    ------------------------------



  • 18.  RE: Cons of MDSAP

    Posted 02-May-2017 14:19
    Mostly it's that this thread is getting so long, I was thinking someone might not find their way to your other response.  Perhaps because, upon seeing the 7, they promptly fainted and read no further... ;)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 19.  RE: Cons of MDSAP

    Posted 02-May-2017 14:26
    Julie,

    He may have meant the following:

    Health Canada (HC) will implement the replacement starting from Jan 1, 2017 for two years. During a two year period, HC will accept certificates issued under both CMDCAS and MDSAP. 

    As of January 1, 2019, HC will only accept MDSAP certificates. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.







  • 20.  RE: Cons of MDSAP

    Posted 02-May-2017 14:27
    David, yes, given the context of the statement, that seems right.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 21.  RE: Cons of MDSAP

    Posted 02-May-2017 22:07
    Indeed. A quality guru at Elsmar Cove once sagely observed that "compliance hijacked quality years ago." I think there may even be a case to be made, that the perhaps well-intentioned QSR did quality more harm than good, by giving companies something to comply with.  I'm afraid the Case for Quality will ultimately prove to be just another brick in that wall.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 22.  RE: Cons of MDSAP

    Posted 01-May-2017 09:41

    Stacey, all of your observations are correct, but, based on my understanding of the MDSAP program, I don't see them as drawbacks of the MDSAP, but as drawbacks of pursuing more than ISO 13485 certification, MDSAP or no MDSAP.

    If you only need ISO 13485 certification to sell in your markets, then I can't see any reason to use MDSAP.   It is designed for companies that want multiple regulatory audits because they want to sell in markets that require multiple regulatory audits, not just ISO 13485 certification.

    1)  The application process is much more detailed than ISO 13485 because the ISO 13485 application is only for an ISO 13485 audit, while the application process for MDSAP is for multiple audits.  The question is whether it is more time and cost effective to arrange for a single MDSAP audit than for these multiple audits, not whether it is more time and cost effective to arrange for any given single audit.

    2)  The audits will be longer, more complex, and costly than ISO 13485 audits, but not more so than the combination of audits you select.  Under MDAPS, you can choose to be simultaneously audited to, for example, FDA, ANVISA, and MO 169 requirements, you can choose to forego MDSAP, and do each audit separately.

    3-4) Yes, I think the multijurisdictional transparency question is the most interesting one. I asked about it in Vancouver.  Actually, I limited my question to the fact that FDA practices more transparency than any other jurisdiction in the world, and that FDA has said it will treat MDSAP reports like is own EIRs (along with, presumably, any resulting warning letters, consent decrees, etc). If so, this may come as shock to companies who are used to having their regulatory dirty laundry safely hidden from public scrutiny.  Based on the responses, I concluded that no one has it thus far, nor is anyone eager to do so. That said, I don't see it as a drawback/con that is likely to increase over time, which was the focus of Harsh's question. If it is a drawback/con of the MDSAP today, it will probably be the same drawback/con in 20 years, too.

    5) If you need to be audited for compliance in 6 jurisdictions, then the auditor(s) will have to be trained in the requirements of all 6 jurisdictions, whether there is a MDSAP program or not. There should be no requirement for a MDSAP auditor who conducting an MDSAP audit covering only 3 jurisdictions to be trained in anything but the requirements for those 3 jurisdictions. If that is a requirement, that is a problem, especially during this early adoption phase, when trained auditors are at a premium.  (I count only 5 jurisdictions participating in the MDSAP program?)

    6) This comment puzzles me. I just learned that Canada recently adopted ISO 13485 as its QSR-equivalent. I can't imagine any company that is so globally oriented that it would choose to use MDSAP wouldn't also have ISO 13485 certification.  I think this means that, for these companies, instead of having to do their ISO audit as a separate audit, they can now include it in their MDSAP audit, but I'm not sure about that.  I also think that, until Health Canada adopted ISO 13485 as its QSR-equivalent, you couldn't include ISO 13485 in your MDSAP audit, so perhaps Health Canada's goal was to let ISO 13485 in the back door, so to speak.

    You seem to be looking at MDSAP as an alternative to ISO 13485 certification, which I don't think it is, nor that it was ever intended to be.  But, again, this is MDSAP as I understand it, and I'm just following it as a point of interest, not because I'm involved in these kinds of audits. Perhaps others here can clarify some misunderstanding I have, and which would shed a different light.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 23.  RE: Cons of MDSAP

    Posted 01-May-2017 11:29

    Stacey,

     

    You said, "5) Internal Auditors need to be MDSAP qualified - that's learning 6 regulations. These Internal Audits must occur at the locations prior to the external MDSAP audit."

     

    I apparently missed the requirement for MDSAP qualified internal auditors. Can you point me to a document and a citation? Are there any special requirements to show the auditor qualification such as a certificate from an accredited external training course? Would internal objective evidence of auditor competency following ISO 13485:2016 Clause 6.2 be sufficient?



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------



  • 24.  RE: Cons of MDSAP

    Posted 01-May-2017 15:45
    We have a blog on our website that may answer some of your questions...
    http://www.orielstat.com/blog/2016/11/30/mdsap/

    ------------------------------
    Arno Pantalone MS
    Oriel STAT A MATRIX
    Wyomissing PA
    United States
    ------------------------------



  • 25.  RE: Cons of MDSAP

    Posted 01-May-2017 17:14
    Harsh, thanks for asking this question.  So far the responses have been very educational for me!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 26.  RE: Cons of MDSAP

    Posted 01-May-2017 20:24
    I must add that I don't see any cons associated with Health Canada's decision to require all manufacturers to have a MDSAP certificate as cons associated with Health Canada's decision to require all manufacturers to have a MDSAP certificate.  I don't see them as cons associated with the MDSAP program, which does not, as far as I know, require any jurisdiction to do this.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 27.  RE: Cons of MDSAP

    Posted 02-May-2017 08:28
    Julie,

    If I interpret your comment correctly, I agree. I actually am generally in favor of MDSAP as a concept, so long as it remained voluntary. However, I think a big downside is the Canadian decision to make it mandatory. For really small companies like mine, that adds a lot of overhead with little to no discernible benefit.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
    ------------------------------



  • 28.  RE: Cons of MDSAP

    Posted 02-May-2017 10:35
    I agree that voluntary is the key.  I don't know HC's reasons, but I'm going to be pondering the possibilities.

    I think MDSAP is a good start, but it increases efficiency, not harmonization.  I understand that goal is next up, but I think it will take them at least 5 years to get MDSAP comfortably implemented. Then they can focus on harmonizing, and maybe in another 10 we will start to see some real progress toward that goal. 

    The potentially nice thing about MDSAP is that it puts all the different requirements of all the jurisdictions in front of everyone, the better to appreciate the similarities and differences. 

    As a result, I anticipate that some harmonization will be realized relatively easily, almost naturally, from a simple realization that some of the differences aren't meaningful, the kind of thing you get when 5 (or 6) different people all draw perfectly good maps to get from here to there, and all of them are a little different in the details.  And because some of the jurisdictions will see specific things others are requiring, and decide they like those requirements better than their own.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 29.  RE: Cons of MDSAP

    Posted 02-May-2017 14:31
    ONE MORE THING....

    Can anyone explain how you can replace ISO 13485 with MDSAP, given that MDSAP isn't a QSM/GMP standard?   It's just an audit program, not an audit standard, right?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 30.  RE: Cons of MDSAP

    Posted 02-May-2017 15:45
    From my understanding you aren't replacing ISO 13485 with MDSAP, to sell in Canada you still need to have your ISO certification MDSAP is replacing CMDCAS (which is the subsections of the CMDR that are considered different from what ISO requires). If that makes sense.

    I also thought that MDSAP was not required by anyone other than HC. As in although you will need to be audited to it to sell in Canada you don't have to to sell in the US. So you will have your ISO audit and choose the box that says MDSAP Canada (like you do now for CMDCAS) but not for anyone else (FDA) unless you want to. Am I wrong?

    ------------------------------
    Keri Froese RAC
    Quality Assurance Manager
    Spartan Bioscience
    Dunrobin ON
    Canada
    ------------------------------



  • 31.  RE: Cons of MDSAP

    Posted 02-May-2017 16:27
    MDSAP certificates represent the application of an audit methodology to determine compliance with the requirements of ISO 13485 and relevant regulatory requirements for QMS through a single audit for multiple regulators.

    There will be NO NEED to have an ISO 13485 certificate, and I really encourage everyone to contact their current CMDCAS Registrar about your transition to MDSAP.  Better yet, may I recommend you to take a course to develop competence to ensure accurate information is being presented and discussed at your management reviews?  If you do not have an MDSAP contact, I suggest you get in touch with either Gary Minks @ TUV-Süd or Tony Rizzo @ BSI.  I know both men and they are very knowledgeable and have helped me greatly.

    Regarding the certificate, please know the Auditing Organizations will issue an "MDSAP Certificate" and it is this certificate that is used when making application with Health Canada for a Medical Device Licence, (mandatory as of 01 January 2019). The Auditing Organizations must ensure specific requirements are stated on a MDSAP certificate, and these requirements are found in the document MDSAP AU P0026.002 Certification Document Requirements 2015-09-22 (available on the Internet for download and review). 

    Anyone choosing not to download and read the document about certificates, I have provided an excerpt from Section 9, Audit Criteria, for you:

    The certification document shall state the criteria that were used in the audit of the manufacturer. This shall include (both):

    -  ISO 13485:2003: Only the international version will be accepted. National or regional adoptions of the standard may not appear on MDSAP certification documents; and

    -  the following regulatory requirements as audited and applicable to the manufacturer:

    Australia:
    -  Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure [if design controls are part of the certification]; OR
    -  Therapeutic Goods (Medical Devices) Regulations,2002, Schedule 3 Part 4 – Production Quality Assurance Procedure [if design controls are excluded from the certification]

    Brazil:
    -  RDC ANVISA n. 16/2013
    -  RDC ANVISA n. 23/2012
    -  RDC ANVISA n. 67/2009

    Canada:
    - Medical Devices Regulations – Part 1- SOR 98/282

    Japan:
    -  MHLW Ministerial Ordinance 169, Article 4 to Article 68
    -  PMD Act (,as applicable)

    United States:
    -  21 CFR 820*
    -  21 CFR 803
    -  21 CFR 806
    -  21 CFR 807 – Subparts A to D
    -  21 CFR 821 (where applicable) 

    * When United States requirements are audited, 21 CFR 820 should appear on the certification document unless the Auditing Organization has confirmed the audited organization is exempt (by FDA regulation) from all Quality System Regulation requirements other than 21 CFR 820.180 and 198. 

    Note:  Auditing Organizations can issue MDSAP certificates referencing jurisdictions where the manufacturer does not yet have market authorization.






  • 32.  RE: Cons of MDSAP

    Posted 02-May-2017 19:10
    Hey everyone, I just noticed the MDSAP AU P0026.002 Certification Document Requirements 2015-09-22  is published before the release of ISO 13485:2016 (2016-03-01), so the content in section 9 most like will change from "ISO 13485:2003" to "ISO 13485:2016".  

    Either way, only the international version of the standard will be accepted, meaning the MDSAP certificates cannot read "CAN/CSA-ISO 13485:16", "AAMI/ANSI/ISO 13485:2003/(R)2009", or "JIS Q 13485:2005", etc. for the Canadian, American, or Japanese, etc. national versions.





  • 33.  RE: Cons of MDSAP

    Posted 02-May-2017 21:39

    Well, I'm not familiar with CMDCAS, but if the subsections of the CMDR that are different from what ISO requires, this suggests these subsections are requirements, and I still don't get it.  It still sounds like trying to replace requirements with non-requirements.  But I'll let that go because I don't need to understand this to that level of detail.

    As for your second paragraph, that's how I understand it as well, which makes me wonder about Ginger's concern that all of the nit-picky MDSAP HC audit findings will be sent to FDA.  I wouldn't expect this to happen unless you included the QSR in your MSDAP audit, and maybe not even then, I don't know.  I did get the idea that all the MDSAP reports will be going to everyone who is part of the IMDRF group that is working on MDSAP, but as feedback on the program, not for a compliance review.   And I assume that at some point this practice will cease, as the program stabilizes and the volume is such they can't read all the reports anyway.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 34.  RE: Cons of MDSAP

    Posted 09-May-2017 12:08

    Due to the MDSAP RAC's "opt-out" prohibition, Health Canada's MDSAP mandate essentially makes MDSAP mandatory in the other MDSAP jurisdictions too (thus involving automatic disclosure of audit results to the RAs in each MDSAP jurisdiction). But some companies doing business in multiple MDSAP jurisdictions have never been inspected by RAs after 3, 4, 5, even 10 years.

    So my concern is in regards to the legality of disclosing the MDSAP audit results to the RAs in this way when the RAs such as FDA and ANVISA have not enacted corresponding laws/legislation.                                                  



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 35.  RE: Cons of MDSAP

    Posted 09-May-2017 15:20

    By the way, to clarify the aforementioned MDSAP RAC "opt-out" prohibition:

     

    If the manufacturer's devices are

    1. marketed in Canada (thereby making MDSAP mandatory as of 1 January 2019 for such a manufacturer); and
    2. also marketed in another MDSAP jurisdiction(s) (i.e., Australia, Brazil, Japan, or the United States),


    then the manufacturer is not allowed to exclude the requirements of the other jurisdictions from its MDSAP audit, and the audit results will automatically be provided to the RAs in those jurisdictions.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 36.  RE: Cons of MDSAP

    Posted 10-May-2017 09:59
    An updated MDSAP FAQ was published after the Vancouver meeting:

    https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf

    95.Can the manufacturer exclude a jurisdiction from the scope of an MDSAP audit?

    A manufacturer may exclude the requirements of a jurisdiction where the organization does not intend to supply medical devices. In other words, audit criteria under the MDSAP include at a minimum ISO 13485 and the medical device regulations that are applicable in any of the participating regulatory authority's jurisdiction where the organization supplies medical devices.

    I would say that this dooms the MDSAP program to failure, but I can't, because success and failure is predicate on objectives, and I'm not sure what those might be.  If MDSAP is intended to meet the needs of large device companies that sell in all of the MDSAP jurisdictions, to increase auditing business for AOs, to add burden to the smaller and mid-sized device companies, and/or to make industry pay for audits that taxpayers once paid for, then maybe it will be very successful.

    I also wonder about the IMDRF's objectives with respect to MDSAP, given that it closed this work item in 2012, long before the pilot had even gotten underway.  I'm inclined to take this as an indicator that IMDRF itself is not especially interested in it, maybe never really was.  It would also seem to leave MDSAP as a global program without a global home.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------