Regulatory Open Forum

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
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I'm looking forward to it.  I think will be a really informative webinar.  Thx for RAPS Chicago and Twin Cities Chapters hosting it

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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
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Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

Dear Annie,

Is it possible to see the video of this event?
I could not find if the video is available or not in the registration form. 
It starts from AM4:00 in Japan and my company doesn't allow me to join it (at least officially).

Iida

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Soichiro Iida
Kyoto-Shi
Japan
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Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

I would also be interested in viewing a video of the event at a later time, if that is possible.

Thanks

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Travis Scott
Regulatory Affairs
Rifton NY
United States
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Original Message:
Sent: 17-Jan-2021 19:57
From: Soichiro Iida
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

Dear Annie,

Is it possible to see the video of this event?
I could not find if the video is available or not in the registration form.
It starts from AM4:00 in Japan and my company doesn't allow me to join it (at least officially).

Iida

------------------------------
Soichiro Iida
Kyoto-Shi
Japan

Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

RAPS learning portal has a very detailed review on China NMPA UDI regulations, implementations and differences with FDA etc. China has implemented the UDI requirements for the 1^st batch of products already and its online-data base is fully running. We did the training on China NMPA UDI topic last December. The first batch of medical devices including the high-risk implantable devices are mandated to submit their UDI data into the China UDI database. Below are some key highlight.  Here is the link to the talk. https://learningportal.raps.org/contentdetails?id=1646F6B136B142068CAC25D454537061

• What is the latest scope/requirements for China UDI submission?
• UDI implementation impact on public tendering and volume purchasing.
• Learn about the key policy, regulations, and standards for China UDI.
• Understand the key components of UDI regulations.
• Familiar with the NMPA UDI pilot and UDI database.
• Clarify the difference between FDA UDI & China UDI.
• Best practice and key takeaways for overseas manufacturers.

Just want to share this with all in case you need to take a deeper dive on China UDI after this global session. 
Grace

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
------------------------------

Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

Hi @Soichiro Iida and @Travis Scott, webinar recordings are shared in the Member Knowledge Center​. The best way to ensure access to the webcast, both the live and recorded versions, is to register for the event ahead of time. By doing so, you'll receive a link to the recording (whether you attend the live presentation or not) within approximately 48 hours of the activity. ​​​​

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------

Thank you so much for the explanation!
I will register the attracted event in future.

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Soichiro Iida
Kyoto-Shi
Japan
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Original Message:
Sent: 19-Jan-2021 19:33
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

Hi @Soichiro Iida and @Travis Scott, webinar recordings are shared in the Member Knowledge Center​. The best way to ensure access to the webcast, both the live and recorded versions, is to register for the event ahead of time. By doing so, you'll receive a link to the recording (whether you attend the live presentation or not) within approximately 48 hours of the activity. ​​​​

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org

Original Message:
Sent: 15-Jan-2021 08:56
From: Annie O'Brien
Subject: Upcoming webcast – How many countries UDI systems is your company ready for?

The RAPS Chicago and Twin Cities Chapters are hosting a webcast on 18 January, "How many countries UDI systems is your company ready for?" Is your company ready for the next country's UDI regulation system? Attend this chapter webcast to understand the similarities and differences in global UDI regulations.

------------------------------
Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
------------------------------