How to sell Veterinary Devices to Canada

L

luloo117117

#1
Hello,

How can we sell veterinary devices to Canada? What is the regulation requirement?

As I know, ISO 13485 under CMDCAS is needed for medical device, but how about veterinary devices?

thanks

Leon
 
Elsmar Forum Sponsor
L

luloo117117

#4
Does anybody can give more detailed explaination about what we should do to sell veterinary therapy laser to Canada?

Thanks

Leon
 
L

luloo117117

#6
Yes, called Health Canada. I was told that there is no specific regulation should comply with except sec. 3, 19~21 of Food & Drug Act of Canada. A statement "This is a veterinary device for animal use ONLY, do not use for human under any circumstances." is suggested to be put into user manual or instruction.
 
Thread starter Similar threads Forum Replies Date
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
K Can I sell IVDs to Chiropractors? US Food and Drug Administration (FDA) 1
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
M Honeywell CMM's - Why Honeywell will no longer sell their manuals Federal Aviation Administration (FAA) Standards and Requirements 2
M Can a PLD Registered in only one state sell prescription drugs to one in another state Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 17
I Incoming insepction needs repair - sell as "new", "brand new", or something else Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
Marc Buy-Sell Forum Cleaned Up - 20181029 Buy, Sell or Trade - NO Commercial Advertisements 0
S We are planning to sell a Medical Device Group Canada Medical Device Regulations 1
R Clinical Trial to sell in the EU - Necessary or Not? ISO 13485:2016 - Medical Device Quality Management Systems 5
O 510(k) Exempt OTC - Can we sell this device on Amazon? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Can we sell units that were chosen for process validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Can a foreign manufacturer sell directly to US customers? Other US Medical Device Regulations 4
S Sell a Non-RoHS device, manufactured before RoHs regulations became effective? EU Medical Device Regulations 2
B WEEE requirements if I sell devices outside the EU RoHS, REACH, ELV, IMDS and Restricted Substances 3
J What are the regulatory requirements to sell a Class II Medical Device in USA? Other US Medical Device Regulations 7
P Requirements to sell Medical Devices in India Other Medical Device Regulations World-Wide 4
A Medical Device Licensing - We are planning to sell another product Canada Medical Device Regulations 2
Marc Definition Sell By, Use By and Best Before - Food Label Content Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
A CE Certificate is valid until 3.12.2013 - Can I still sell the products in Europe? EU Medical Device Regulations 10
G Can a Distributer in USA sell a medical device (CE marked) to Europe? CE Marking (Conformité Européene) / CB Scheme 2
E FDA and ISO 13485 - Once we get our 510K are we free to sell product? US Food and Drug Administration (FDA) 2
W PQ Validation Parts: Retain or Sell? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T One Man Medical Devices Company implementing 21 CFR Part 820 in order to sell to US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Mil Spec Parts: Who can make and sell them? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
I What are the Government of India requirements to sell OEM Medical Devices in India? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Do I need to have UL or TUV or other mark to sell device in USA IEC 60601 - Medical Electrical Equipment Safety Standards Series 49
K What is required to sell a medical product in the US? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
apestate How do you sell a DCMA Inspector on replacements for obsolete items? Various Other Specifications, Standards, and related Requirements 9
A Export - We would like to sell our products to various United States installations US Food and Drug Administration (FDA) 5
Marc Tearing Apart a McAfee Hard-Sell Anti-Virus Ad After Work and Weekend Discussion Topics 6
M Free Trade Certificate - Planning to sell our products to some foreign countries Other Medical Device and Orthopedic Related Topics 30
J What certification is Required to Sell medical devices in the UK EU Medical Device Regulations 3
S Who can we sell Aerospace parts to? Federal Aviation Administration (FAA) Standards and Requirements 11
D Does a Company have to appoint a US Agent to sell product in Canada or vise versa? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Sell Class III medical devices to Canada prior to Health Canada Approval ISO 13485:2016 - Medical Device Quality Management Systems 11
J Healthcare Canada vs. FDA - Differences in obtaining approval to sell product Canada Medical Device Regulations 2
Q How to sell an idea to the upper management when... Quality Manager and Management Related Issues 12
S Only the FDA can sell in USA - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirements to market/sell existing medical device in EU, Canada ISO 13485:2016 - Medical Device Quality Management Systems 3
G Companies that sell Promo Items For Quality Misc. Quality Assurance and Business Systems Related Topics 11
Marc Delphi to close, sell most plants under deal World News 0
Marc DaimlerChrysler set to sell Chrysler to Cerberus World News 11
chris1price What Class 1 Medical Device Registration is required to sell in Poland EU Medical Device Regulations 3
Q Canadian Licensing to sell Class I and Class II Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 2
D How do I sell 5s to middle management? Lean in Manufacturing and Service Industries 9
Marc Fiat and GM on road to court battle - Fiat wants to sell World News 1
C Don't Sell, Make Them Buy Coffee Break and Water Cooler Discussions 2
F Regulatory requirements to sell and market medical devices in Australia? ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom