Why You Need Class III Medical Devices

A medical device must be licensed for a particular purpose by Health Canada before it can be sold in Canada.

Depending on the risks associated with that device’s use, a device would be licensed by Health Canada as Class I, II, III, or IV following the Medical Devices Regulations under the Food and Drugs Act, with Class I having the lowest risk and Class IV having the highest.[1] A medical device that is used as an In-vitro Diagnostic Device (IVDD), like an on-site urine drug test, must have a Class III licence.

While the risks associated with providing a sample may seem limited, the results of that point-of-care test can have far-reaching consequences, like referring an employee to a Substance Abuse Professional or suspending that employee from safety-sensitive job functions.

 

The Risks of Buying and Using Unlicensed Medical Devices

Because the results of a drug test can have such an impact on the donor, it is essential that specimen collectors use Class III licensed devices. The puse of unlicensed devices can negatively affect not only the donor, but everyone involved in the specimen collection timeline:

  • For the donor:  Unlicensed devices have not been approved for on-site drug testing, and those devices are potentially unsafe.[2]
  • For the collector:  Using unlicensed devices may results in a questionable test outcome and a potentially legally indefensible testing process.[2]
  • For the seller:  Selling unlicensed devices can lead to prosecution by Health Canada with fines of up to $5,000 or imprisonment.[3]

 

How to Ensure Your Medical Devices Are Class III Licensed

Shopping online can be risky, and purchasing medical devices online is no exception. As Health Canada cautions, buying medical devices from the Internet carries a number of risks:

  • The device could be unlicensed.
  • The device could be subject to a recall that the purchaser may not be made aware of.
  • The device could be counterfeit.
  • The device could be used or second-hand.
  • The device could be damaged due to improper handling or storage.[4]

Verify Diagnostics provides Class III devices that are tested to the highest standard to ensure that the device is safe, reliable, and effective.

To find out more, contact us toll-free at 1 (866) 446-2953.


1. Medical Devices Regulations (SOR/98-282) (http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-7.html#h-19).

2. Purchase of Licensed Medical Devices for Use in Healthcare Facilities and Requests for Proposal / Information (RFP / RFI) Processes (http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/2013-purchase_md_achat_im-eng.php).

3. 2004 March Report of the Auditor General of Canada (http://www.oag-bvg.gc.ca/internet/english/parl_oag_200403_02_e_14894.html).

4. Buying Medical Devices from the Internet (http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/med_mat-eng.php).

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