The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Legal Representation in Canada (Medical Devices)

Monitor the Elsmar Forum
Courtesy Quick Links

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

Jennifer Kirley's
Conway Business Services

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
canada, legal agent
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 12th July 2017, 10:24 AM
amjadrana's Avatar

Total Posts: 148
Question Legal Representation in Canada (Medical Devices)

I have been asked by a prospective customer, whether I can be a legal representative for them. Can some one tell me whether it is a requirement in Canada?
Thank you for your inputs.

Sponsored Links
  Post Number #2  
Old 1st August 2017, 10:39 AM
RA Guy

Total Posts: 70
Re: Legal Representation in Canada (Medical Devices)

amjadrana, there is nothing akin to a mandatory requirement such as "US Authorized Representative" or for CE Marked devices an EU "Authorized Representative" for non-domestic manufacturers, but the original manufacturer and any other businesses involved in importing and distributing in Canada MAY need to comply with Establishment Licensing requirements. The link below explains who needs to comply under different scenarios.

Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) -

If the device is class 2-4, there is an allowance to appoint a regulatory correspondent on the device licence application forms. This appointment is not mandatory, but is a convenience to manufacturers that may want to appoint an affiliate or 3rd party for a variety of reasons.

Medical Device Application Forms -
Thanks to RA Guy for your informative Post and/or Attachment!

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


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
Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? Jango EU Medical Device Regulations 6 4th June 2018 01:19 AM
Active Implantable Medical Devices - Legal Traceability Requirements Aphel ISO 13485:2016 - Medical Device Quality Management Systems 7 26th February 2015 05:43 AM
Legal Representation Insurance in the US for Travelers kgott Coffee Break and Water Cooler Discussions 37 2nd November 2012 10:42 AM
Sell Class III medical devices to Canada prior to Health Canada Approval luloo117117 ISO 13485:2016 - Medical Device Quality Management Systems 11 19th August 2009 06:53 AM
Classification of medical devices in Canada rogerisberg ISO 13485:2016 - Medical Device Quality Management Systems 1 7th July 2005 09:44 AM

The time now is 07:04 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"