Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

I agree with John Beasley.

The scope of the audit must include the national requirements of each regulatory authority jurisdiction where you are placing devices that require quality management oversight. I think that if you are only placing class I devices in Canada then the class I devices do not require a quality management system audit in Canada in which case Canada could be excluded, but, if any devices placed in Canada require a quality management system audit then Canada must be included in the audit scope. I think it is the same for each of the jurisdictions that recognize MDSAP. I think that only Canada currently is scheduled to mandate MDSAP as a requirement from Jan 2019 and MDSAP is not the national requirement in each country, but, as soon as you commit to MDSAP all jurisdictions where you place eligible devices must be included in the MDSAP audit.

Currently the participating regulatory authorities are Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan and FDA US. 



------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States
------------------------------

Original Message:
Sent: 01-Nov-2017 10:11
From: John Beasley
Subject: MDSAP Audit Scope

You may only omit those MDSAP countries where you do not sell product.  If you sell both in the USA and Canada, you must include both USA and Canada.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

​See the MDSAP FAQ document.  Questions related to the audit scope are: 16, 49, 93 and 95.  

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

------------------------------
Gary Minks
Head of Quality & Regulatory Affairs
Siemens / Dedicated2imaging
Portsmouth NH
United States
------------------------------

Original Message:
Sent: 02-Nov-2017 08:00
From: Paul Brooks
Subject: MDSAP Audit Scope

I agree with John Beasley.

The scope of the audit must include the national requirements of each regulatory authority jurisdiction where you are placing devices that require quality management oversight. I think that if you are only placing class I devices in Canada then the class I devices do not require a quality management system audit in Canada in which case Canada could be excluded, but, if any devices placed in Canada require a quality management system audit then Canada must be included in the audit scope. I think it is the same for each of the jurisdictions that recognize MDSAP. I think that only Canada currently is scheduled to mandate MDSAP as a requirement from Jan 2019 and MDSAP is not the national requirement in each country, but, as soon as you commit to MDSAP all jurisdictions where you place eligible devices must be included in the MDSAP audit.

Currently the participating regulatory authorities are Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan and FDA US.



------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States

Original Message:
Sent: 01-Nov-2017 10:11
From: John Beasley
Subject: MDSAP Audit Scope

You may only omit those MDSAP countries where you do not sell product.  If you sell both in the USA and Canada, you must include both USA and Canada.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

This brings up an question on which I would appreciate group insight.  The only MDSAP countries in which we manufacture and register products in our name are the US and Canada.  However, we are also a contract manufacturer and the products we manufacture are sold through our customer worldwide with their labeling, including Brazil, Australia, and Japan.  The customer is responsible for regulatory registration in those countries, and we ship only to the customer's distribution centers in the US, Europe, and Singapore, not directly to Japan, Australia, or Brazil.

I have prepared our MDSAP Audit application to specify only Canada and the US as relevant jurisdictions for the scope of our audit.  I noted in the MDSAP FAQ that countries which should be included are those in which the subject company registers products.  Is my interpretation of the relevant countries correct?

Thanks

------------------------------
James Bonds
Director Regulatory Affairs
Woodstock GA
United States
------------------------------

Original Message:
Sent: 03-Nov-2017 08:16
From: Gary Minks
Subject: MDSAP Audit Scope

​See the MDSAP FAQ document.  Questions related to the audit scope are: 16, 49, 93 and 95.

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

------------------------------
Gary Minks
Head of Quality & Regulatory Affairs
Siemens / Dedicated2imaging
Portsmouth NH
United States

Original Message:
Sent: 02-Nov-2017 08:00
From: Paul Brooks
Subject: MDSAP Audit Scope

I agree with John Beasley.

The scope of the audit must include the national requirements of each regulatory authority jurisdiction where you are placing devices that require quality management oversight. I think that if you are only placing class I devices in Canada then the class I devices do not require a quality management system audit in Canada in which case Canada could be excluded, but, if any devices placed in Canada require a quality management system audit then Canada must be included in the audit scope. I think it is the same for each of the jurisdictions that recognize MDSAP. I think that only Canada currently is scheduled to mandate MDSAP as a requirement from Jan 2019 and MDSAP is not the national requirement in each country, but, as soon as you commit to MDSAP all jurisdictions where you place eligible devices must be included in the MDSAP audit.

Currently the participating regulatory authorities are Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan and FDA US.



------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States

Original Message:
Sent: 01-Nov-2017 10:11
From: John Beasley
Subject: MDSAP Audit Scope

You may only omit those MDSAP countries where you do not sell product.  If you sell both in the USA and Canada, you must include both USA and Canada.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

I believe the correct phrase is, "countries your organization places product on that market". This goes to your role. If your role for that product is manufacturer, importer or distributor in that country/region, you are placing product on the market. If you are a contract manufacturer for the product, you are simply part of the product realization and not placing product on the market. I would recommend you clearly outline your role for those products within documentation in your QMS. In addition, you should verify with the Auditing Organization so they define your scope correctly as well.

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

Original Message:
Sent: 04-Nov-2017 09:29
From: James Bonds
Subject: MDSAP Audit Scope

This brings up an question on which I would appreciate group insight.  The only MDSAP countries in which we manufacture and register products in our name are the US and Canada.  However, we are also a contract manufacturer and the products we manufacture are sold through our customer worldwide with their labeling, including Brazil, Australia, and Japan.  The customer is responsible for regulatory registration in those countries, and we ship only to the customer's distribution centers in the US, Europe, and Singapore, not directly to Japan, Australia, or Brazil.

I have prepared our MDSAP Audit application to specify only Canada and the US as relevant jurisdictions for the scope of our audit.  I noted in the MDSAP FAQ that countries which should be included are those in which the subject company registers products.  Is my interpretation of the relevant countries correct?

Thanks

------------------------------
James Bonds
Director Regulatory Affairs
Woodstock GA
United States

Original Message:
Sent: 03-Nov-2017 08:16
From: Gary Minks
Subject: MDSAP Audit Scope

​See the MDSAP FAQ document.  Questions related to the audit scope are: 16, 49, 93 and 95.

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

------------------------------
Gary Minks
Head of Quality & Regulatory Affairs
Siemens / Dedicated2imaging
Portsmouth NH
United States

Original Message:
Sent: 02-Nov-2017 08:00
From: Paul Brooks
Subject: MDSAP Audit Scope

I agree with John Beasley.

The scope of the audit must include the national requirements of each regulatory authority jurisdiction where you are placing devices that require quality management oversight. I think that if you are only placing class I devices in Canada then the class I devices do not require a quality management system audit in Canada in which case Canada could be excluded, but, if any devices placed in Canada require a quality management system audit then Canada must be included in the audit scope. I think it is the same for each of the jurisdictions that recognize MDSAP. I think that only Canada currently is scheduled to mandate MDSAP as a requirement from Jan 2019 and MDSAP is not the national requirement in each country, but, as soon as you commit to MDSAP all jurisdictions where you place eligible devices must be included in the MDSAP audit.

Currently the participating regulatory authorities are Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan and FDA US.



------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States

Original Message:
Sent: 01-Nov-2017 10:11
From: John Beasley
Subject: MDSAP Audit Scope

You may only omit those MDSAP countries where you do not sell product.  If you sell both in the USA and Canada, you must include both USA and Canada.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?

This is clearly stated in the MDSAP application as well. Keep in mind that the MDSAP is NOT adding anything to requirements, it just simply is bringing them all together in a single audit. 

Do not fear the audit.

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

Original Message:
Sent: 01-Nov-2017 09:03
From: Anonymous Member
Subject: MDSAP Audit Scope

This message was posted by a user wishing to remain anonymous

Hi all,

We currently sell in the US, Canada, Japan, and Australia.  We will be transitioning to MDSAP this year to maintain our Canadian licenses, but were hoping to limit the scope of our first audit to Canada to ease the transition.  Does MDSAP require that the audit be performed against every participating country you sell in regardless if that country requires MDSAP yet, or can we choose to omit the US portion of MDSAP and maintain our current FDA inspection schedule until the FDA requires MDSAP?