How to sell Veterinary Devices to Canada

[luloo117117]

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

 

[Coury Ferguson]

Can anybody help here?

 

[Jim Wynne]

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

Although this link to Health Canada is concerned with veterinary drugs and not devices, per se, it might provide a good starting point for your inquiry.

 

[luloo117117]

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

Thanks

Leon

 

[MIREGMGR]

How did the people at [email protected] respond to your questions?

 

[luloo117117]

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.

 

[ANASTASIYA]

Hello, everyone!

Can you please tell me if it is possible to sell a medical product in America as a veterinary product if it is 510k FDA approved.

 

[akp060]

Hello, everyone!

Can you please tell me if it is possible to sell a medical product in America as a veterinary product if it is 510k FDA approved.

(I understand if my response is not comprehensive here, but..) The basics of the FDA clearance (since 510k is a "cleared" pathway) is that you cannot go against the intended use of the product. You may have to alter the design to some extent and consider labeling it only for veterinary use. There cannot be any cross-over between medical devices for human use and animal use in labelling as long as it is not supported by design.