Regulatory Open Forum

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Hello,
I think every country has the whole set of regulations these days.
For Russia some can be found on https://roszdravnadzor.gov.ru/en, but this is really about 5-10% of necessary information. There is also site of Eurasian Economic COmmsision - information on upcoming common legislation for Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan can be found there.
http://eec.eaeunion.org/, but it is quite inconvenient  & has information on all products, not only medical ones (so you really have to know the document you are looking for).
There is big number of documents that are not published on those sites, and market players normally get them via local professional associations, otherwise you are very unlikely to know about their existence (before your company will be fined for not following them.)). Those "smaller" documents will be in Russian only - market's participants may translate them at their own expence.

------------------------------
Oksana Kolosova
F. Hoffman-LaRoche
Moscow
------------------------------

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thank you Oksana Kolosova!  Looking forward to hearing from others to help if anyone has a master list of global regs to consider worldwide... Seems like we could write a book on this (if anyone is interested in that type of academic pursuit...)
Dr. Frestedt

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 12-May-2021 10:03
From: Oksana Kolosova
Subject: ROW regulations list

Hello,
I think every country has the whole set of regulations these days.
For Russia some can be found on https://roszdravnadzor.gov.ru/en, but this is really about 5-10% of necessary information. There is also site of Eurasian Economic COmmsision - information on upcoming common legislation for Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan can be found there.
http://eec.eaeunion.org/, but it is quite inconvenient  & has information on all products, not only medical ones (so you really have to know the document you are looking for).
There is big number of documents that are not published on those sites, and market players normally get them via local professional associations, otherwise you are very unlikely to know about their existence (before your company will be fined for not following them.)). Those "smaller" documents will be in Russian only - market's participants may translate them at their own expence.

------------------------------
Oksana Kolosova
F. Hoffman-LaRoche
Moscow

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Hello Joy,
The master list will be so helpful instead of swimming through different websites and links.. it will have to be updated frequently though...
I can support this..
Thanks,
Meena

------------------------------
Meena Garg
Regulatory and QA Consultant, Vaccines
Sanofi Pasteur
Brampton ON
Canada
------------------------------

Original Message:
Sent: 12-May-2021 10:09
From: Joy Frestedt
Subject: ROW regulations list

Thank you Oksana Kolosova!  Looking forward to hearing from others to help if anyone has a master list of global regs to consider worldwide... Seems like we could write a book on this (if anyone is interested in that type of academic pursuit...)
Dr. Frestedt

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 12-May-2021 10:03
From: Oksana Kolosova
Subject: ROW regulations list

Hello,
I think every country has the whole set of regulations these days.
For Russia some can be found on https://roszdravnadzor.gov.ru/en, but this is really about 5-10% of necessary information. There is also site of Eurasian Economic COmmsision - information on upcoming common legislation for Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan can be found there.
http://eec.eaeunion.org/, but it is quite inconvenient  & has information on all products, not only medical ones (so you really have to know the document you are looking for).
There is big number of documents that are not published on those sites, and market players normally get them via local professional associations, otherwise you are very unlikely to know about their existence (before your company will be fined for not following them.)). Those "smaller" documents will be in Russian only - market's participants may translate them at their own expence.

------------------------------
Oksana Kolosova
F. Hoffman-LaRoche
Moscow

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

I could gladly help with LATAM reg

------------------------------
Cristina Viruega
Regional Regulatory Affairs Manager
Mexico City
Mexico
------------------------------

Original Message:
Sent: 13-May-2021 07:00
From: Meena Garg
Subject: ROW regulations list

Hello Joy,
The master list will be so helpful instead of swimming through different websites and links.. it will have to be updated frequently though...
I can support this..
Thanks,
Meena

------------------------------
Meena Garg
Regulatory and QA Consultant, Vaccines
Sanofi Pasteur
Brampton ON
Canada

Original Message:
Sent: 12-May-2021 10:09
From: Joy Frestedt
Subject: ROW regulations list

Thank you Oksana Kolosova!  Looking forward to hearing from others to help if anyone has a master list of global regs to consider worldwide... Seems like we could write a book on this (if anyone is interested in that type of academic pursuit...)
Dr. Frestedt

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 12-May-2021 10:03
From: Oksana Kolosova
Subject: ROW regulations list

Hello,
I think every country has the whole set of regulations these days.
For Russia some can be found on https://roszdravnadzor.gov.ru/en, but this is really about 5-10% of necessary information. There is also site of Eurasian Economic COmmsision - information on upcoming common legislation for Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan can be found there.
http://eec.eaeunion.org/, but it is quite inconvenient  & has information on all products, not only medical ones (so you really have to know the document you are looking for).
There is big number of documents that are not published on those sites, and market players normally get them via local professional associations, otherwise you are very unlikely to know about their existence (before your company will be fined for not following them.)). Those "smaller" documents will be in Russian only - market's participants may translate them at their own expence.

------------------------------
Oksana Kolosova
F. Hoffman-LaRoche
Moscow

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

There are several services that offer very comprehensive libraries of such documents from all around the world.  They include Tarius and Cortellis for Regulatory Intelligence. Most pharmaceutical companies subscribe to one or another (or both).  They are typically enterprise-wide and I am not sure if they are available for an individual subscription.

------------------------------
Lawrence Liberti RAC
Adjunct Research Professor
Temple University QARA Fort Washington
Holland PA
United States
------------------------------

Original Message:
Sent: 12-May-2021 10:09
From: Joy Frestedt
Subject: ROW regulations list

Thank you Oksana Kolosova!  Looking forward to hearing from others to help if anyone has a master list of global regs to consider worldwide... Seems like we could write a book on this (if anyone is interested in that type of academic pursuit...)
Dr. Frestedt

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 12-May-2021 10:03
From: Oksana Kolosova
Subject: ROW regulations list

Hello,
I think every country has the whole set of regulations these days.
For Russia some can be found on https://roszdravnadzor.gov.ru/en, but this is really about 5-10% of necessary information. There is also site of Eurasian Economic COmmsision - information on upcoming common legislation for Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan can be found there.
http://eec.eaeunion.org/, but it is quite inconvenient  & has information on all products, not only medical ones (so you really have to know the document you are looking for).
There is big number of documents that are not published on those sites, and market players normally get them via local professional associations, otherwise you are very unlikely to know about their existence (before your company will be fined for not following them.)). Those "smaller" documents will be in Russian only - market's participants may translate them at their own expence.

------------------------------
Oksana Kolosova
F. Hoffman-LaRoche
Moscow

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

I'm not sure this is exactly what you're looking for, but I refer to this often

https://clinregs.niaid.nih.gov/

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Angion Biomedica Corporation
Carmel IN
United States
------------------------------

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thank you Beth Weinberg!

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 13-May-2021 09:35
From: Beth Weinberg
Subject: ROW regulations list

I'm not sure this is exactly what you're looking for, but I refer to this often

https://clinregs.niaid.nih.gov/

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Angion Biomedica Corporation
Carmel IN
United States

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

A great source that I often refer to is the "Regulatory Process Charts" provided by RAMS (Emergo).  The process charts provide a high-level overview illustrating device approval processes for specific markets. Maybe not specifically what you are looking for, but can definitely lead you in the right direction as you input the country and applicable regulatory information is available.  

https://rams.emergobyul.com/layout/regulatoryprocesscharts


------------------------------
Vashone Thomas
Senior Director of QA/RA
Nephros, Inc.
South Orange NJ
United States
------------------------------

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thank you Vashone Thomas. Unfortunately this Emergo website is restricted to Emergo customers... I can't see the process charts you are referring to in your suggestion below... are these publicly available somewhere?

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 13-May-2021 12:05
From: Vashone Thomas
Subject: ROW regulations list

A great source that I often refer to is the "Regulatory Process Charts" provided by RAMS (Emergo).  The process charts provide a high-level overview illustrating device approval processes for specific markets. Maybe not specifically what you are looking for, but can definitely lead you in the right direction as you input the country and applicable regulatory information is available.

https://rams.emergobyul.com/layout/regulatoryprocesscharts


------------------------------
Vashone Thomas
Senior Director of QA/RA
Nephros, Inc.
South Orange NJ
United States

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

You can sign up for some level of free access to some of Emergo documents for free.  I did a couple years ago and still have access.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 13-May-2021 14:57
From: Joy Frestedt
Subject: ROW regulations list

Thank you Vashone Thomas. Unfortunately this Emergo website is restricted to Emergo customers... I can't see the process charts you are referring to in your suggestion below... are these publicly available somewhere?

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 13-May-2021 12:05
From: Vashone Thomas
Subject: ROW regulations list

A great source that I often refer to is the "Regulatory Process Charts" provided by RAMS (Emergo).  The process charts provide a high-level overview illustrating device approval processes for specific markets. Maybe not specifically what you are looking for, but can definitely lead you in the right direction as you input the country and applicable regulatory information is available.

https://rams.emergobyul.com/layout/regulatoryprocesscharts


------------------------------
Vashone Thomas
Senior Director of QA/RA
Nephros, Inc.
South Orange NJ
United States

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thanks Leonard Eisher. Just two concerns from me: 1) if Emergo requires sign in for "free" access, this does not feel the same as "publicly available" to me and 2) I'm pretty sure Emergo has an agreement the user may need to accept during sign-in to protect the Emergo IP (intellectual property) from commercial use. I am really cautious about these ethical boundaries and would not want to use Emergo IP for commercial interests like the ones contemplated in this question for a list of global regulations.  Cheers, Dr. Frestedt

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 15-May-2021 02:07
From: Leonard Eisner
Subject: ROW regulations list

You can sign up for some level of free access to some of Emergo documents for free.  I did a couple years ago and still have access.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 13-May-2021 14:57
From: Joy Frestedt
Subject: ROW regulations list

Thank you Vashone Thomas. Unfortunately this Emergo website is restricted to Emergo customers... I can't see the process charts you are referring to in your suggestion below... are these publicly available somewhere?

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 13-May-2021 12:05
From: Vashone Thomas
Subject: ROW regulations list

A great source that I often refer to is the "Regulatory Process Charts" provided by RAMS (Emergo).  The process charts provide a high-level overview illustrating device approval processes for specific markets. Maybe not specifically what you are looking for, but can definitely lead you in the right direction as you input the country and applicable regulatory information is available.

https://rams.emergobyul.com/layout/regulatoryprocesscharts


------------------------------
Vashone Thomas
Senior Director of QA/RA
Nephros, Inc.
South Orange NJ
United States

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

HI Joy

I am not aware of any single link and even if it existed it would rapidly become out of date.  however you can consolidate the contact information for the individual agencies into a small number of sources, all of them harmonization bodies:

www.imdrf.org for US, Europe, Australia, Japan, Canada, Russia, China, Singapore, S Korea
http://www.ahwp.info/index.php/node/32  for most of Asia, mid east, and some S America and Africa.
www.pahwp.org   for Africa
There's also useful info at the APEC medical devices page https://www.apec.org/RHSC/RHSC-Priority-Work-Areas/Medical-Devices 

Arthur

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

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thank you Arthur. The IMDRF seems to be more about harmonized standards and not regulations per se. I find this conversation interesting because the regulations are so hard to find and often the regulatory authorities websites do not have English translations (e.g., China, etc). Seems like FDA website is not available to other countries in their native languages either. I believe we might benefit from some globalized regulatory support even if only a list of links and reliable language translators. Seems like something the WHO or other organizations could support.  Maybe even RAPS?
thanks again,
Joy

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 14-May-2021 01:39
From: Arthur Brandwood
Subject: ROW regulations list

HI Joy

I am not aware of any single link and even if it existed it would rapidly become out of date.  however you can consolidate the contact information for the individual agencies into a small number of sources, all of them harmonization bodies:

www.imdrf.org for US, Europe, Australia, Japan, Canada, Russia, China, Singapore, S Korea
http://www.ahwp.info/index.php/node/32  for most of Asia, mid east, and some S America and Africa.
www.pahwp.org   for Africa
There's also useful info at the APEC medical devices page https://www.apec.org/RHSC/RHSC-Priority-Work-Areas/Medical-Devices

Arthur

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

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

The FRPath Project (www.FRPath.org) maintains an up to date listing of links to almost 135 agencies worldwide.  The service is available to academics or to authorized users whose organizations support the project via educational grants. See the Portals section of the web site.

------------------------------
Lawrence Liberti RAC
Adjunct Research Professor, Temple University
Holland PA
United States
------------------------------

Original Message:
Sent: 14-May-2021 01:39
From: Arthur Brandwood
Subject: ROW regulations list

HI Joy

I am not aware of any single link and even if it existed it would rapidly become out of date.  however you can consolidate the contact information for the individual agencies into a small number of sources, all of them harmonization bodies:

www.imdrf.org for US, Europe, Australia, Japan, Canada, Russia, China, Singapore, S Korea
http://www.ahwp.info/index.php/node/32  for most of Asia, mid east, and some S America and Africa.
www.pahwp.org   for Africa
There's also useful info at the APEC medical devices page https://www.apec.org/RHSC/RHSC-Priority-Work-Areas/Medical-Devices

Arthur

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

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Excellent activity and resource. Thank you, Lawrence! I see they have 155 "agencies" when I looked in today... As Arthur mentioned the lists might need to get updated regularly and I hope this project continues for that purpose and to make our jobs easier!
Joy

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 24-Jun-2022 10:14
From: Lawrence Liberti
Subject: ROW regulations list

The FRPath Project (www.FRPath.org) maintains an up to date listing of links to almost 135 agencies worldwide.  The service is available to academics or to authorized users whose organizations support the project via educational grants. See the Portals section of the web site.

------------------------------
Lawrence Liberti RAC
Adjunct Research Professor, Temple University
Holland PA
United States

Original Message:
Sent: 14-May-2021 01:39
From: Arthur Brandwood
Subject: ROW regulations list

HI Joy

I am not aware of any single link and even if it existed it would rapidly become out of date.  however you can consolidate the contact information for the individual agencies into a small number of sources, all of them harmonization bodies:

www.imdrf.org for US, Europe, Australia, Japan, Canada, Russia, China, Singapore, S Korea
http://www.ahwp.info/index.php/node/32  for most of Asia, mid east, and some S America and Africa.
www.pahwp.org   for Africa
There's also useful info at the APEC medical devices page https://www.apec.org/RHSC/RHSC-Priority-Work-Areas/Medical-Devices

Arthur

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

Original Message:
Sent: 09-May-2021 10:01
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Probably not regularly updated and not sure of its overall accuracy, but for casual hobbyists this WHO site is at least amusing.

https://www.who.int/medical_devices/countries/en/

---------------------------------
Sam Lazzara
Medical Device Quality Consultant
San Francisco Bay Area, California USA
https://mdqc.blog
---------------------------------



Original Message:
Sent: 09-May-2021
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Thank you Sam!  That's the one I remember… great to have more resources to tie together global regulations!

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 14-May-2021 20:55
From: Sam Lazzara
Subject: ROW regulations list

Probably not regularly updated and not sure of its overall accuracy, but for casual hobbyists this WHO site is at least amusing.

https://www.who.int/medical_devices/countries/en/

---------------------------------
Sam Lazzara
Medical Device Quality Consultant
San Francisco Bay Area, California USA
https://mdqc.blog

Original Message:
Sent: 09-May-2021
From: Joy Frestedt
Subject: ROW regulations list

^{Does anyone have a list of worldwide regulations for medical products they are willing to share? I used to have a link to a good resource on this but can't seem to find it any more.  Thanks!}

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------