The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Click the graphic above.
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
canada, cfg (certificate of foreign government), exports and exporting, india
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 27th April 2012, 07:31 AM
SQ2012 SQ2012 is offline
Involved in Discussions

 
Registration Date: Mar 2012
 
Posts: 11
Thanks Given to Others: 1
Thanked 1 Time in 1 Post
Karma Power: 11
Karma: 15
SQ2012 has less than 100 Karma points so far.
Please Help! CFG Certificate for Medical Device Registration in India

Hi,

We are trying to register a medical device from Canada in India which is FDA approved. Now the Indian regulatory authorities have requested for CFG certificate. Is it possible to obtain and submit a CFG certificate for a product that will be manufactured and exported from Canada and not USA???

Last edited by harry; 28th April 2012 at 06:19 AM. Reason: There's a world of difference between CGF and CFG - thread title edited

Sponsored Links
  #2  
Old 28th April 2012, 05:19 AM
Stijloor's Avatar
Stijloor Stijloor is offline
Cross Forum Moderator

 
Registration Date: May 2003
Location: Charlotte, North Carolina.
 
Posts: 14,455
Thanks Given to Others: 3,184
Thanked 4,508 Times in 3,193 Posts
Karma Power: 1541
Karma: 25153
Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.
Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.
Re: CGF Certificate for Medical Device Registration in India

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
Sponsored Links

  #3  
Old 1st May 2012, 10:56 AM
Michael Malis's Avatar
Michael Malis Michael Malis is offline
Appreciated Member

 
Registration Date: Mar 2006
Location: Northeast
 
Posts: 282
Thanks Given to Others: 56
Thanked 138 Times in 101 Posts
Karma Power: 67
Karma: 2372
Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.
Re: CGF Certificate for Medical Device Registration in India

In short No!
Product need to be manufactured and/or distributed from US.

Regards,
Mike

__________________

The cure for anything is salt water: sweat, tears or the sea. - Isak Dinesen
  #4  
Old 13th May 2012, 08:03 AM
Gachon Gachon is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Sep 2009
Location: Tokyo, JAPAN
 
Posts: 4
Thanks Given to Others: 0
Thanked 6 Times in 2 Posts
Karma Power: 20
Karma: 40
Gachon has less than 100 Karma points so far.
Re: CFG Certificate for Medical Device Registration in India

Mike, I would appreciate it if you could give us the rationale.

Thanks and best regards,
  #5  
Old 13th May 2012, 09:57 AM
Michael Malis's Avatar
Michael Malis Michael Malis is offline
Appreciated Member

 
Registration Date: Mar 2006
Location: Northeast
 
Posts: 282
Thanks Given to Others: 56
Thanked 138 Times in 101 Posts
Karma Power: 67
Karma: 2372
Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.Michael Malis is appreciated, and has over 1700 Karma points.
Re: CFG Certificate for Medical Device Registration in India

No rationale! Only fact:

FDA will only issue CFG if product is manufactured and/or distributed from US.

__________________

The cure for anything is salt water: sweat, tears or the sea. - Isak Dinesen
Thanks to Michael Malis for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide

Do you find this discussion thread helpful and informational?


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
Smilies 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
Schedule D II Format for Medical Device Registration India SQ2012 Other Medical Device Regulations World-Wide 3 2nd May 2012 04:21 PM
Class III Medical Device with CE Mark Approval - India Registration Process jampot ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 10 30th April 2012 03:02 AM
Medical Device Registration(India) and Power of Attorney attestation clarification! Dr.lee Other Medical Device Regulations World-Wide 9 27th September 2010 03:12 PM
AIAG PPAP Manual Forms: CFG-1003, CFG-1004, CFG-1005 dbulak APQP and PPAP 3 6th February 2010 11:44 PM
CFG - Certificate for Foreign Government - Medical Device Company based in CA, USA mukesh sabarad US Food and Drug Administration (FDA) 4 14th October 2009 08:52 AM



The time now is 04:34 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272