The Cove Business Standards Discussion Forums
Is TGA approval required for a ARTG listed IVD for a sample type addition?
UL - Underwriters Laboratories - Health Sciences
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Is TGA approval required for a ARTG listed IVD for a sample type addition? - Page 2


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
artg (australian register of therapeutic goods), ivd (in vitro diagnostic) devices and reagens, sted (summary technical documents), tga (therapeutic goods administration)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 19th October 2014, 05:12 AM
Ronen E

 
 
Total Posts: 3,736
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Quote:
In Reply to Parent Post by romit singh View Post

Hi Sreenu,

Impact to intended use can be determined by GMDN. If the intended use update necessitates consideration of new GMDN term then a new application will be required. Alternatively, if the scope of the intended use has changed but can still be covered by the same GMDN term then a change application can be made.

Kind regards
Romit
Hi,

Has this been stated to you by the TGA or have you seen it in a written guidance? IMO the statement above might be a little far-reaching. Sometimes 2 significantly different intended uses might fall under the same GMDN code and at the same time these would be considered two different kinds of devices (even when the manufacturer and sponsor are the same).

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!

Sponsored Links
  Post Number #10  
Old 20th October 2014, 12:53 AM
medwise

 
 
Total Posts: 102
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Please refer to page 175 and 176 of ARGMD (current version). See attached.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Kind of Medical Devices_ARGMD.pdf (143.4 KB, 15 views)
  Post Number #11  
Old 20th October 2014, 07:22 PM
Ronen E

 
 
Total Posts: 3,736
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Quote:
In Reply to Parent Post by medwise View Post

Please refer to page 175 and 176 of ARGMD (current version). See attached.
I know the ARGMD.

There are several escape clauses in that page which I could elaborate about how they leave the TGA the liberty to require separate ARTG entries for devices seemingly falling under the same Kind, based on that short & sweet definition. If you are from Australia you probably know that seldom written words mean exactly what their face value shows. There's always a subtext, and the vague parts are there for a reason. I wouldn't go into that because it seems pointless, I'll just mention that I was involved in real cases where according to that page a single ARTG entry was required but in practice it didn't work that way.

Cheers,
Ronen.
  Post Number #12  
Old 20th October 2014, 08:03 PM
medwise

 
 
Total Posts: 102
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Couple of months ago I was submitted a change request where intended use was expanded (i.e. could be used in various procedures rather than the specific one which it was registered to in first place 5 years ago) even though it was a kind of medical device. Note change request in this case would have been avoided if the intended purpose was kept generic when new application was made back in the days.

I do not disagree with you however most of the sponsor from my experience tend to ignore/aloof of the concept of "kind of medical device".
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Can I view listed drug products on FDA website similar to listed medical devices? SGquality Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and other related Regulations) 4 16th May 2016 01:34 PM
Addition of French Language (translation) - New 510(k) required? endlesslovehv Other US Medical Device Regulations 1 29th September 2010 09:34 AM
Sample Approval by Customer - Customer doesn't send/return their approval geamami IATF 16949 - Automotive Quality Systems Standard 10 22nd March 2008 12:56 PM
ISO 9001 and Type Approval certification johnnybegood Other ISO and International Standards and European Regulations 1 24th November 2003 12:00 PM
ILC/PT for 25% of the testing listed in their lab scope for Type A Tests Ken K General Measurement Device and Calibration Topics 4 13th March 2003 01:05 AM



The time now is 11:05 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"