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MDSAP

  • 1.  MDSAP

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jun-2020 08:32
    This message was posted by a user wishing to remain anonymous

    I work for a medium size medical device company with 3 manufacturing sites in Europe and 1 in the USA. We are looking at the MDSAP process but I need some help in understanding  how it would work for us.

    I have four questions.
    1. We have a global electronic QM system which we all use but I am not sure what happens if we decide to get an MDSAP audit. Do they need to look at the 4 sites or can they just look at 1 and go into the global system for the others. We are thinking that this way we can have all 4 audited to all of the MDSAP countries. Is this possible?

    2. We hear both good and bad comments about MDSAP and it is difficult to decide if the bad comments are real or theoretical. If one site fails in the above situation, do they all fail?
    3. What happens when one countries requirements are not met?
    4. Is MDSAP cost effective.

    Thanks.


  • 2.  RE: MDSAP

    Posted 03-Jun-2020 12:27
    Hello,
    1. In my experience each of our manufacturing sites were audited to MDSAP.
    2. It's hard to fail the MDSAP audit given what I've seen from different auditors - one company I know of definitely should have failed, but were issued their MDSAP and given two years to fix their issues.
    3. The problem with MDSAP is that if you want that certificate then your QMS needs to show compliance to all 5 members' QMS -- this can be a huge burden for companies especially if they aren't in those markets. In theory you should not be issued the MDSAP certificate if you don't meet one of the countries requirements, but it depends on the auditor.
    4. I don't know if it is cost effective as I never saw the bill; however, each country still reserves the right to audit you in addition to the MDSAP audit. The biggest problem with MDSAP is that if you do poorly then ALL 5 of the member states will know just how badly you did and may decide to do their own audit.

    The big question your company should ask itself is "do we want to sell in Canada?" because if you want to sell in Canada then you need the MDSAP certificate.

    ------------------------------
    George Tiller
    Los Angeles CA
    United States
    ------------------------------

    Original Message


  • 3.  RE: MDSAP

    Posted 04-Jun-2020 08:18

    George,

    You made one statement in your response that is not correct. You as the manufacturer decide which of the five countries requirements you want to be audited to. The basis, of course is 13485, and all those applicable requirements forms the basis for the audit. But the additional regulatory requirements for the countries you select are then audited. You could select just one country, but that may not be cost effective. 

    Also, South Korea and Argentina can now view the audit reports, but any additional requirements for those countries are not added to the audit. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 4.  RE: MDSAP

    Posted 04-Jun-2020 08:49
    Hello George-

    We sent one of our RA professionals to training on MDSAP and the trainer indicated like you have that you get to select which countries are in scope of the MDSAP audit. When it came time to schedule the audit, our CB informed us that we do not get to select, it's based on what countries we are distributing product into at the time. We could not choose to exclude any country in which we distributed in-scope devices. Have you had a different experience?

    To the OP-

    The only thing that really makes it more difficult is the repeat finding escalation. Findings are written against the 2nd or 3rd (?) level clause (X.X or X.X.X) which makes it easier to get repeat findings in subsequent audits, increasing the MDSAP grade of the finding.

    It's only cost effective if the regulatory agencies accept the audit in lieu of their own inspections. If the FDA/HC/etc choose to perform routine inspection of your facilities in addition to MDSAP then it is not cost effective. The audit cycle is very expensive.

    ------------------------------
    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
    ------------------------------

    Original Message


  • 5.  RE: MDSAP

    Posted 04-Jun-2020 14:57
    Thank you for the clarification Edwin!
    I was unaware that you could specify which countries that you want to be audited against (based on the training I had). I've only worked for a company that was audited to all 5. 

    I definitely did not know that SK and Argentina can view the audit reports, that is interesting. Can they view them without your consent or do they ask to see it and you must provide it?

    Joshua,
    Like I mentioned to Edwin, we were audited to all 5, but that is because the company was actively distributing all of the MDSAP countries.

    ------------------------------
    George Tiller
    Los Angeles CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: MDSAP

    Posted 08-Jun-2020 09:08
    Hi George, I was a little alarmed when Edwin explained that the affiliate members Argentina and South Korea can view the audit reports. That is not entirely true. In the  MDSAP Affiliate Members Roles and Responsibilities Policy is is described under article 4.4. that 'MDSAP Affiliate Members can obtain MDSAP audit reports and/or MDSAP certificates by contacting participating manufacturers. MDSAP Affiliate Members will not have access to the MDSAP database on the Regulatory Exchange Platform – (REPs) secure IT web portal'.
    They can ask to see it and you can provide it.

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 7.  RE: MDSAP

    Posted 04-Jun-2020 11:23
    Hi, 

    1- You need ISO 13485:2016 Certificate.
    2- Decide which countries out of 5 you want to place your products in. You will have to comply with regulations of countries you selected. You can't distribute in a country that is part of MDSAP but for which you have not been audited.
    3- All manufacturing facilities are audited for MDSAP.
    4- It usually takes 2 to 3 extra audit days for MDSAP (merged with ISO 13485:2016). Also depends on if you chose a new NB for MDSAP or stay with your current NB.
    5- We have MDSAP with UL for 3 years and had no issues.

    Regards,

    ------------------------------
    Saqib Tanweer
    Manager QA/RA
    Toronto ON
    Canada
    ------------------------------

    Original Message


  • 8.  RE: MDSAP

    Posted 05-Jun-2020 07:24
    Hello Saqib

    You can certainly distribute in the US without  ISO 13485: 2016 AND without MDSAP.  At this time the legal requirement doesn't mandate an ISO 13485 based quality system or MDSAP.  While FDA wants to move to ISO 13485,  it will need legislative  changes to FD&C Act and underlying  sections to do so (i.e. remove or modify 21 CFR 820).

    FDA  was going to try  to implement  ISO 13485 requirements  last year, then pushed the target back to April 1st this year, and then blew by that deadline  because of COVID-19.  They hope to get legislation  enacted  by this fall,  but it is an election year, they are under Congressional fire for relaxation  of regulations and non-enforcement of drug inspection  regulations and swamped with COVID EUA applications.

    I am betting Congress and FDA  do not get the mandate changed this year; though FDA will accept MDSAP in lieu of regular inspections now, it is not mandated.

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 9.  RE: MDSAP

    Posted 05-Jun-2020 12:02
    Hi Ginger,

    Agreed. Thanks for correcting me,

    I took FDA as granted I guess being using MDSAP for 3 years.

    Yes, I don't think switch to ISO 13485 will be happening soon in current situation.

    Best Regards,

    ------------------------------
    Saqib Tanweer
    Manager QA/RA
    Toronto ON
    Canada
    ------------------------------

    Original Message


  • 10.  RE: MDSAP

    Posted 09-Jun-2020 03:03
    Edited by Arthur Brandwood 09-Jun-2020 03:03
    MDSAP is effectively an increment of ISO 13485 to add specific regulatory content of the QMS for the markets supplied.  We have found our clients manage it well when seen in that light, including those starting with no QMS at all, and it's been effective for those addressing multiple markets.

    I do want to clarify the country selection issue.

    The rules have changed from time to time.  Currently, you can select which countries you are audited against but at a minimum you must include all those coutries in which you currently supply, and if you wish to then later supply ina country you are not MDSAP certified for - you must extend the scope to cover the new market.

    Essentially - if you elect to have MDSAP, you must include in the scope all markets currently supplied.  You can chose to be certified for markets not supplied as well - in anticipation of going there in the future..

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------

    Original Message


  • 11.  RE: MDSAP

    Posted 09-Jun-2020 04:18
    Hello,

    I would also like to clarify the statement Edwin made in regard to selecting which countries you are audited.  Arthur said it correctly if you sell or distribute in any one of the five countries, it must be included in your MDSAP audit scope.  It is an all or nothing approach.  Just because you need MDSAP for Health Canada, and you also sell in the United States, you can not "choose" to not include U.S. in the audit scope.  If you also sell in the U.S. it must be included in scope of your MDSAP certification.  You can select to not choose a country in your MDSAP audit scope, but this is only precluded by the fact your organisation does not sell or distribute any product in that country.  (Personally I view as the fallacy of the MDSAP program because you should be able to select which countries you want in the audit scope and not be an all of nothing approach; if I wanted to include U.S. to help with inspections being done, I should be able to do that.  Now, if I sell in U.S. the FDA will get a copy of my MDSAP audit report, which might not beneficial for my company.)

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


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