Regulatory Open Forum

I hope everyone had a great Halloween and recovered from the sugar bolus :)

Curious how you all handle updates to existing labeling - particularly IFUs - to add languages, registration numbers, local representative info, etc. but don't modify any existing content.  Do you re-open Phase 1/Inputs to add these as formal design requirements?  Or do you handle these through the normal change control process and/or a commercialization process for new markets?

Although I've been in the business of getting regulatory approvals for a long time, I've not actually been involved in this part of the process.  I've always just told people we got approval, then the product started shipping to that country.  What is the magic that makes that happen?  I'm interested in really simple, streamlined, but yet compliant, best practices that won't make our R&D team flip out.  

Thanks in advance!

Tina

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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
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Hi Tina,

I am seeing you are probably most thinking about introducing the product into a new market, i.e. new languages but not updating any of the content.  First, make sure you have a process for "turning on" new markets such as a market authorisation process where you do not need to go back into the design control process.  This can be managed through the change control system and then say in your electronic inventory system there is a mechanism to allow shipping to a new country.  Usually when I am auditing, I do query how a company can or can not sell to countries assuring they have the market approval.  The main controlling document is a "Regulatory Strategy" or "Regulatory Status" type of document either by Product Family (which I prefer keeps it consistent with other regulatory documents) or even just a tabular listing of the products and regulatory status.  When say you want to introduce to a new country, the Regulatory Strategy/Status document is updated through change control.  Part of this change control function is showing the device is approved or registered in the country, meaning going back to the Strategy/Status document supporting this approval.  Then as part of the change control process, the market introduction procedure kicks in where the "flag" or ability to now ship to country 'X' is allowed.  Unfortunately it is not a simple process because there are many process that interact with each other, i.e. registration, regulatory authority notification, change control, shipping, distribution, labeling, PMS, etc.  But I would not think you have to go all the way back into design controls to introduce to a new country as you can use existing documents in the QMS to manage this process.  It is not common that companies would go back to original Product Requirements Document to update when there are more subtle changes that could be handled through change control.  What I explained it just one way I have seen, there are most likely other ways this could be addressed as well.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-Oct-2019 23:23
From: Tina O'Brien
Subject: IFU changes

I hope everyone had a great Halloween and recovered from the sugar bolus :)

Curious how you all handle updates to existing labeling - particularly IFUs - to add languages, registration numbers, local representative info, etc. but don't modify any existing content.  Do you re-open Phase 1/Inputs to add these as formal design requirements?  Or do you handle these through the normal change control process and/or a commercialization process for new markets?

Although I've been in the business of getting regulatory approvals for a long time, I've not actually been involved in this part of the process.  I've always just told people we got approval, then the product started shipping to that country.  What is the magic that makes that happen?  I'm interested in really simple, streamlined, but yet compliant, best practices that won't make our R&D team flip out.

Thanks in advance!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

I do not fully understand your question and scenarios. To answer your question here I present an example: You need to update IFU to add languages, registration numbers, local representative info, etc. for a new market. Your product code will be different for that market.

A simple process will look like this

1. QA function creates a change control record for this change. Make sure product code for the impacted market is on hold for distribution until the change record is closed.
2. RA involves in getting the IFU revised (review and approve internally), implement the approved version in production if you want but the finished product will be on hold until this change record is closed.
3. RA gets the IFU approved in the new market.
4. QA will update and close the change control record.
5. QA release product for that market and Distribution take care of the rest.


------------------------------
Tu Nguyen
RA Analyst
Arlington TX
United States
------------------------------

Original Message:
Sent: 31-Oct-2019 23:23
From: Tina O'Brien
Subject: IFU changes

I hope everyone had a great Halloween and recovered from the sugar bolus :)

Curious how you all handle updates to existing labeling - particularly IFUs - to add languages, registration numbers, local representative info, etc. but don't modify any existing content.  Do you re-open Phase 1/Inputs to add these as formal design requirements?  Or do you handle these through the normal change control process and/or a commercialization process for new markets?

Although I've been in the business of getting regulatory approvals for a long time, I've not actually been involved in this part of the process.  I've always just told people we got approval, then the product started shipping to that country.  What is the magic that makes that happen?  I'm interested in really simple, streamlined, but yet compliant, best practices that won't make our R&D team flip out.

Thanks in advance!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Thanks for your response!  We don't have separate product codes by country.  We're also a very small (100 staff) company still working with a paper-based QMS.

So when we enter a new market, I have to update the existing labeling to add languages, registration number, etc. We don't have the bandwidth to change this structure at the present. 

My question is not about control of product, but how you manage label content.  Do you have labeling requirements as design inputs or do you have a separate/parallel process to ensure that all content (regulatory, marketing, etc) is defined and verified? We're currently doing this within design controls and I find it overly burdensome.

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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 01-Nov-2019 11:10
From: Tu Nguyen
Subject: IFU changes

I do not fully understand your question and scenarios. To answer your question here I present an example: You need to update IFU to add languages, registration numbers, local representative info, etc. for a new market. Your product code will be different for that market.

A simple process will look like this

1. QA function creates a change control record for this change. Make sure product code for the impacted market is on hold for distribution until the change record is closed.
2. RA involves in getting the IFU revised (review and approve internally), implement the approved version in production if you want but the finished product will be on hold until this change record is closed.
3. RA gets the IFU approved in the new market.
4. QA will update and close the change control record.
5. QA release product for that market and Distribution take care of the rest.


------------------------------
Tu Nguyen
RA Analyst
Arlington TX
United States

Original Message:
Sent: 31-Oct-2019 23:23
From: Tina O'Brien
Subject: IFU changes

I hope everyone had a great Halloween and recovered from the sugar bolus :)

Curious how you all handle updates to existing labeling - particularly IFUs - to add languages, registration numbers, local representative info, etc. but don't modify any existing content.  Do you re-open Phase 1/Inputs to add these as formal design requirements?  Or do you handle these through the normal change control process and/or a commercialization process for new markets?

Although I've been in the business of getting regulatory approvals for a long time, I've not actually been involved in this part of the process.  I've always just told people we got approval, then the product started shipping to that country.  What is the magic that makes that happen?  I'm interested in really simple, streamlined, but yet compliant, best practices that won't make our R&D team flip out.

Thanks in advance!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------