Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic: 
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Respectfully, I have to disagree here. Australia does require either an MDSAP approach for ISO 13485 certificate, or a TGA audit of the QMS.

TGA changed to this requirement in 2018.  

A simple ISO 13485:2016 certificate will not cut it.

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

Original Message:
Sent: 09-Jun-2022 06:12
From: Richard Vincins
Subject: MDSAP required? Australia only

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Hi Ginger,

Well, I would say it is still not required because https://www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds here shows the Table 1 where Initial Audits and Surveillance Audits can use MDD/IVDD or MDR/IVDR or MDSAP audit reports of a Full Quality Assurance audit.  I do agree just having ISO 13485 certification may not be enough.  And on this page https://www.tga.gov.au/medical-device-single-audit-program-mdsap: 'Manufacturers who have been audited under MDSAP may, under some circumstances, avoid routine TGA inspections, however our regulatory model still allows for the TGA to audit manufacturing premises regardless of the availability of MDSAP evidence.'  From information I read, MDSAP is indeed not a requirement but it can help alleviate higher scrutiny or could be used as a pathway in conformity assessment for quality system and product reviews.​

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Jun-2022 08:26
From: Ginger Cantor
Subject: MDSAP required? Australia only

Respectfully, I have to disagree here. Australia does require either an MDSAP approach for ISO 13485 certificate, or a TGA audit of the QMS.

TGA changed to this requirement in 2018.

A simple ISO 13485:2016 certificate will not cut it.

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

Original Message:
Sent: 09-Jun-2022 06:12
From: Richard Vincins
Subject: MDSAP required? Australia only

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Original Message:
Sent: 6/10/2022 9:35:00 AM
From: Richard Vincins
Subject: RE: MDSAP required? Australia only

Hi Ginger,

Well, I would say it is still not required because https://www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds here shows the Table 1 where Initial Audits and Surveillance Audits can use MDD/IVDD or MDR/IVDR or MDSAP audit reports of a Full Quality Assurance audit.  I do agree just having ISO 13485 certification may not be enough.  And on this page https://www.tga.gov.au/medical-device-single-audit-program-mdsap: 'Manufacturers who have been audited under MDSAP may, under some circumstances, avoid routine TGA inspections, however our regulatory model still allows for the TGA to audit manufacturing premises regardless of the availability of MDSAP evidence.'  From information I read, MDSAP is indeed not a requirement but it can help alleviate higher scrutiny or could be used as a pathway in conformity assessment for quality system and product reviews.​

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Jun-2022 08:26
From: Ginger Cantor
Subject: MDSAP required? Australia only

Respectfully, I have to disagree here. Australia does require either an MDSAP approach for ISO 13485 certificate, or a TGA audit of the QMS.

TGA changed to this requirement in 2018.

A simple ISO 13485:2016 certificate will not cut it.

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

Original Message:
Sent: 09-Jun-2022 06:12
From: Richard Vincins
Subject: MDSAP required? Australia only

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Hi Ginger,

Oh I do not want to consider arguing the point, sorry.  I definitely respect the posts you make and I guess my information was not consistent with that as it was still considered maybe an "optional" pathway.  As typically expected the regulations, statements on websites, and even information from individuals is not always consistent.  If a requirement ... yep! ok :)

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Jun-2022 12:14
From: Ginger Cantor
Subject: MDSAP required? Australia only

Hi Richard

A client had TGA state it is a requirement, actually.  Yes, TGA can always audit, of course, much as FDA can.  I thought Arthur Brandwood confirmed that a while ago too in one of these chats. 

Have a good weekend everyone,

Ginger

Original Message:
Sent: 6/10/2022 9:35:00 AM
From: Richard Vincins
Subject: RE: MDSAP required? Australia only

Hi Ginger,

Well, I would say it is still not required because https://www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds here shows the Table 1 where Initial Audits and Surveillance Audits can use MDD/IVDD or MDR/IVDR or MDSAP audit reports of a Full Quality Assurance audit.  I do agree just having ISO 13485 certification may not be enough.  And on this page https://www.tga.gov.au/medical-device-single-audit-program-mdsap: 'Manufacturers who have been audited under MDSAP may, under some circumstances, avoid routine TGA inspections, however our regulatory model still allows for the TGA to audit manufacturing premises regardless of the availability of MDSAP evidence.'  From information I read, MDSAP is indeed not a requirement but it can help alleviate higher scrutiny or could be used as a pathway in conformity assessment for quality system and product reviews.​

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-Jun-2022 08:26
From: Ginger Cantor
Subject: MDSAP required? Australia only

Respectfully, I have to disagree here. Australia does require either an MDSAP approach for ISO 13485 certificate, or a TGA audit of the QMS.

TGA changed to this requirement in 2018.

A simple ISO 13485:2016 certificate will not cut it.

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

Original Message:
Sent: 09-Jun-2022 06:12
From: Richard Vincins
Subject: MDSAP required? Australia only

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!

Hi Ginger,

It is my understanding that within the scope of the original poster's question, MDSAP would not be necessary since they are pursuing registration with EU evidence. I found a conversation between you and Arthur from late 2019 that appears to be what you are referencing, and it seems as though the same conclusion was drawn there (https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=177eeec2-6414-4e03-8dc4-23fbd5eac6e2&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer).

Just to clarify, was your client using EU evidence to register when they were informed that MDSAP was required?

Thanks!

------------------------------
Ian Boland
Regulatory Affairs Specialist
NJ
United States
------------------------------

Original Message:
Sent: 10-Jun-2022 12:14
From: Ginger Cantor
Subject: MDSAP required? Australia only

Hi Richard

A client had TGA state it is a requirement, actually.  Yes, TGA can always audit, of course, much as FDA can.  I thought Arthur Brandwood confirmed that a while ago too in one of these chats. 

Have a good weekend everyone,

Ginger

Original Message:
Sent: 6/10/2022 9:35:00 AM
From: Richard Vincins
Subject: RE: MDSAP required? Australia only

Hi Ginger,

Well, I would say it is still not required because https://www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds here shows the Table 1 where Initial Audits and Surveillance Audits can use MDD/IVDD or MDR/IVDR or MDSAP audit reports of a Full Quality Assurance audit.  I do agree just having ISO 13485 certification may not be enough.  And on this page https://www.tga.gov.au/medical-device-single-audit-program-mdsap: 'Manufacturers who have been audited under MDSAP may, under some circumstances, avoid routine TGA inspections, however our regulatory model still allows for the TGA to audit manufacturing premises regardless of the availability of MDSAP evidence.'  From information I read, MDSAP is indeed not a requirement but it can help alleviate higher scrutiny or could be used as a pathway in conformity assessment for quality system and product reviews.​

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-Jun-2022 08:26
From: Ginger Cantor
Subject: MDSAP required? Australia only

Respectfully, I have to disagree here. Australia does require either an MDSAP approach for ISO 13485 certificate, or a TGA audit of the QMS.

TGA changed to this requirement in 2018.

A simple ISO 13485:2016 certificate will not cut it.

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

Original Message:
Sent: 09-Jun-2022 06:12
From: Richard Vincins
Subject: MDSAP required? Australia only

Hello Anon,

Currently for countries like Australia, USA, Brazil, and Japan there is not per se a requirement, just gives benefits having the Medical Device Single Audit Program (MDSAP) certification.  So you are correct, there is not a specific MDSAP need/requirement for Australia.  Such as in USA this supports not having FDA conduct an inspection (at least not routine QSIT inspections), in Brazil this can be used in lieu of facility inspections as part of registration, etc.  In fact, the only requirement today is Canada needing MDSAP Certificate as part of the Medical Device License (MDL) application process.  I am not a proponent of MDSAP that I have already posted publicly (still waiting for significant positive posts to adjust my position).  There was good intent, but it was implemented badly and still not meeting original intention.  And with the lack of competencies in many areas which these Auditing Organisations (AO) who are also Notified Bodies and also Certification Bodies, are missing there would have to be a significant reason to obtain a MDSAP certificate.  For Australia only, the cost, hassle, struggles, and challenges do not outweigh the benefits - again the reason for obtaining is because MDSAP is an "all or nothing" approach so if you are planning to market in Canada, then you would need at some point.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-Jun-2022 02:05
From: Anonymous Member
Subject: MDSAP required? Australia only

This message was posted by a user wishing to remain anonymous

Dear all,

could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?

It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).

I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)

From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).

Thank you very much for your answers in advance!