Regulatory Open Forum

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

You are probably getting conflicting answers because neither choice you gave is the right answer.

 You cannot limit the scope to some countries and, thereby, exclude countries in which you market a device. For example, if you don't market a device in Australia or Brazil, the scope of the MDSAP audit will include the requirements from Canada, Japan, and the USA only. Regulators in those three countries would get the audit report. However, there is no uniformity on how the regulators handle the report. For example, in Canada a successful audit with an MDSAP certificate will support your license. In the US the report counts as an Establishment Inspection Report, and the company will come off the worklist. As an EIR, FDA intends to classify the result as NAI, VAI, or OAI. However, Congress recently changed the law (FDARA) for inspection frequency from a calendar basis to risk factor evaluation. I don't know how much weight a successful EIR would receive in the risk based algorithm. In fact, I don't even know what the algorithm is; I don't think it is public. On the other hand, MDSAP means you would enjoy the equivalent of a routine FDA Inspection once a year.

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

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

One clarification on what Dan has put out there. This is not a change in scope and the MDSAP audit does NOT add anything to your requirements. This simply makes it more uniform and standardizes the audit model. You already have to meet the regulatory requirements for any country or region where you place product on the market. This is the phrase in the ISO 13485 standard, "applicable regulatory requirements". Some audits have been good about picking these up and some have not been so diligent.

This is an audit to ensure your organization meets the quality management system requirements for the countries or region where you place product on a market. Therefore, the scope of the audit is the applicable regulatory requirements where you place that product on the market. Hopefully that is clear.


------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States
------------------------------

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Unfortunately it is an "all or nothing" approach (which I personally do not necessarily agree with this approach).  If you market in those countries, they must be included in the scope of MDSAP whether you want it or prepared for it.  Dan gave a good example, if you do not market your product in 2 countries and market in 3 countries, those 3 countries must all be included in scope.

Therefore, to comply with Health Canada requirement by the end of 2018, MDSAP audit is required.  If you also sell in U.S., Brazil, and Australia - you will get your MDSAP certificate for Health Canada, but then the AO audit report will also be sent to FDA, ANVISA, and TGA.  There are pros and cons, because as example you may not get a routine inspection from FDA or can leverage the AO audit report to preclude an ANVISA GMP inspection for Class III and IV device.  However, if you have a bad audit (poor auditor) then all of these regulatory entities will get that audit report ... which may instigate a "for cause" inspection.

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

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Hi all;
Check out  https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf  section 95.

"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. "

This should solve the conflicting information. If you supply to Canada and Brazil and you must go for MDSAP for CDN you must include Brazil because you supply to Brazil.

Best
Michael

------------------------------
Michael Maier
Partner
Medidee Services SA
Epalinges
Switzerland
------------------------------

Original Message:
Sent: 03-Dec-2017 02:39
From: Richard Vincins
Subject: MDSAP Scope Clarification

Unfortunately it is an "all or nothing" approach (which I personally do not necessarily agree with this approach).  If you market in those countries, they must be included in the scope of MDSAP whether you want it or prepared for it.  Dan gave a good example, if you do not market your product in 2 countries and market in 3 countries, those 3 countries must all be included in scope.

Therefore, to comply with Health Canada requirement by the end of 2018, MDSAP audit is required.  If you also sell in U.S., Brazil, and Australia - you will get your MDSAP certificate for Health Canada, but then the AO audit report will also be sent to FDA, ANVISA, and TGA.  There are pros and cons, because as example you may not get a routine inspection from FDA or can leverage the AO audit report to preclude an ANVISA GMP inspection for Class III and IV device.  However, if you have a bad audit (poor auditor) then all of these regulatory entities will get that audit report ... which may instigate a "for cause" inspection.

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

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Thank you all for your input but I would still like specific clarification.  Our company sells into Canada, Australia, and US, but not Brazil and Japan.  Under these conditions does an MDSAP auditor review our procedures to ensure they conform to Brazil and Japan regulations, even though we do not sell there?  As part of a gap analysis, would we need to make sure our procedures conform to Brazil and Japan regulations, even though we do not sell there? Or can we request that the MDSAP auditor only audit us to Canada, Australia, and US regulations?

Thank you,
Joy


------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Original Message:
Sent: 03-Dec-2017 07:02
From: Michael Maier
Subject: MDSAP Scope Clarification

Hi all;
Check out  https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf  section 95.

"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. "

This should solve the conflicting information. If you supply to Canada and Brazil and you must go for MDSAP for CDN you must include Brazil because you supply to Brazil.

Best
Michael

------------------------------
Michael Maier
Partner
Medidee Services SA
Epalinges
Switzerland

Original Message:
Sent: 03-Dec-2017 02:39
From: Richard Vincins
Subject: MDSAP Scope Clarification

Unfortunately it is an "all or nothing" approach (which I personally do not necessarily agree with this approach).  If you market in those countries, they must be included in the scope of MDSAP whether you want it or prepared for it.  Dan gave a good example, if you do not market your product in 2 countries and market in 3 countries, those 3 countries must all be included in scope.

Therefore, to comply with Health Canada requirement by the end of 2018, MDSAP audit is required.  If you also sell in U.S., Brazil, and Australia - you will get your MDSAP certificate for Health Canada, but then the AO audit report will also be sent to FDA, ANVISA, and TGA.  There are pros and cons, because as example you may not get a routine inspection from FDA or can leverage the AO audit report to preclude an ANVISA GMP inspection for Class III and IV device.  However, if you have a bad audit (poor auditor) then all of these regulatory entities will get that audit report ... which may instigate a "for cause" inspection.

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

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Joy: If you do not sell into Brazil or Japan, then these would not be included in the scope of MDSAP.  So the answer to both of your questions is no.  Your final question is that your MDSAP application would not include this, so it would not even be asked or reviewed by an AO auditor.

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

Original Message:
Sent: 04-Dec-2017 14:57
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Thank you all for your input but I would still like specific clarification.  Our company sells into Canada, Australia, and US, but not Brazil and Japan.  Under these conditions does an MDSAP auditor review our procedures to ensure they conform to Brazil and Japan regulations, even though we do not sell there?  As part of a gap analysis, would we need to make sure our procedures conform to Brazil and Japan regulations, even though we do not sell there? Or can we request that the MDSAP auditor only audit us to Canada, Australia, and US regulations?

Thank you,
Joy


------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States

Original Message:
Sent: 03-Dec-2017 07:02
From: Michael Maier
Subject: MDSAP Scope Clarification

Hi all;
Check out  https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf  section 95.

"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. "

This should solve the conflicting information. If you supply to Canada and Brazil and you must go for MDSAP for CDN you must include Brazil because you supply to Brazil.

Best
Michael

------------------------------
Michael Maier
Partner
Medidee Services SA
Epalinges
Switzerland

Original Message:
Sent: 03-Dec-2017 02:39
From: Richard Vincins
Subject: MDSAP Scope Clarification

Unfortunately it is an "all or nothing" approach (which I personally do not necessarily agree with this approach).  If you market in those countries, they must be included in the scope of MDSAP whether you want it or prepared for it.  Dan gave a good example, if you do not market your product in 2 countries and market in 3 countries, those 3 countries must all be included in scope.

Therefore, to comply with Health Canada requirement by the end of 2018, MDSAP audit is required.  If you also sell in U.S., Brazil, and Australia - you will get your MDSAP certificate for Health Canada, but then the AO audit report will also be sent to FDA, ANVISA, and TGA.  There are pros and cons, because as example you may not get a routine inspection from FDA or can leverage the AO audit report to preclude an ANVISA GMP inspection for Class III and IV device.  However, if you have a bad audit (poor auditor) then all of these regulatory entities will get that audit report ... which may instigate a "for cause" inspection.

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

Original Message:
Sent: 01-Dec-2017 16:41
From: Joy Pelfrey
Subject: MDSAP Scope Clarification

Hello All,

I have had conflicting answers to a question regarding the scope of an MDSAP audit.  If you have an MDSAP audit, can the manufacturer define and limit the scope to just one country (i.e.Canada) or is an MDSAP auditor required to audit to all 5 countries' regulations and report results to all 5 countries?

Thanks for your insight!

Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------