Sample or Prototype Devices Sent to Customer which are not licenced

M

MJW66

#1
Does anyone know if there is a provision in the CMDR's that allow sample devices to be imported into Canada without going through the licencing process? We have a customer that would like to try one of our devices and I thought that we might be able to label it as "Not for Patient Use" or "Prototype" to see if they liked the device prior to placing subsequent orders. I am reluctant to add it to our licence for someone that actually might not buy it after an initial review.
 
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M

MIREGMGR

#2
Canada's medical device definition, from http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/risk5_risque5_main_principal-eng.php:

For the purpose of these regulations a "medical device" is defined as it appears in the Food and Drugs Act with, however, the exclusion of veterinary products.
......an article, instrument, apparatus or contrivance, including a component, part or accessory of one, that is manufactured, sold or represented for use in:
  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being;
  2. the restoration, correction or modification of a body function or the body structure of a human being;
  3. the diagnosis of pregnancy in a human being; or
  4. the care of a human being during pregnancy and at and after the birth of a child, including the care of the child.
It also includes a contraceptive device but does not include a drug.
As the device maker and labeler, you have control over this. Labeling of course is an integral part of medical device manufacturing. If you label a particular unit of your device as a sample, not to be used as a medical device as defined by the Food and Drugs Act, then that unit of product is not "manufactured, sold or represented" for a medical device purpose and is not a medical device. Thus it is not subject to medical device regulation, per above.
 
N

njhoost

#3
Ditto Above,

However make sure when exporting to Canada you do not use the Harmonized Tariff code that you normally use for your product.

While you may label it with all of these exclusions, if the Canadian Customs see a product tariff code in your customs documents and you (or the device) is not licensed in Canada they may refuse it entry or detain it.

Best to talk to your customs broker about this aspect.
 
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