After a prolonged duration of 18 years, IVD (In vitro Diagnostic) Medical Devices finally fall under the purview of Health Canada’s much awaited finalized labeling guidance. The first draft of this guidance was issued in the year 1998. This guidance emphasizes mainly on:
- New contemplations for electronic labeling and blood glucose monitors
- Following the Official Language Act of Canada in labeling
- New labeling specifications for IVD’s in small containers
As mentioned above, the new labeling rule needs to adhere to the Official Language Act, which demands the companies to use both English and French in their labels for IVDs.
What should the Label Include?
There are certain aspects that are necessary to include in the labeling of IVD devices such as manufacturer’s name and address, the diagnostic name of the device, storage conditions, dosage, and expiry date. Apart from the common information, manufacturers must also include the following details on the label with respect to the IVD devices:
- If the manufacturer aims to sell the device in sterile form, it must indicate the word “Sterile” on the label.
- The label should have the control number in case the IVD device falls in Class III or IV.
- Unique Device Identifier (UDI) is a mandatory element to be present on the label. This should entail the UDI number of the device, the test kit and the medical device family or the group it belongs.
The detailed specifications for mentioning these details on the label are clearly specified in the Health Canada’s Medical Device Guidelines.
The devices that have restricted space for updating detailed information on the label due to small packaging containers can include “internationally recognized symbols” to display the information. However, the package leaflets and inserts should include the essential glossary terms to understand the information on the label.
The new regulation also comprises the detailed stipulations for blood glucose monitoring systems labels that entail labeling regulations for a lancing device, test strips, and glucose meter. Find out the details here. The systems used by multiple patients should include the directions to “clean and disinfect the meter between patients, to change gloves between patients and to only use auto-disabling single use lancing devices.”
Implementation of Electronic Label
The electronic label can be utilized to represent the device information for directors for use. This label will not be implemented to the devices to be sold in public. However, the agency expects that both the electronic and the physical labels should be alike.
In this regard, the agency says. “This information may be provided as downloadable from the internet and/or on electronic data storage devices (e.g., compact disc, digital video disc, or USB flash drive). The electronic label or internet web address must accompany the device at the time of sale and/or delivery and be displayed in a manner that alerts the user to its purpose.”
With the huge scope for IVD Device Manufacturing in Canada, the upcoming labeling guidelines are expected to make or break the success rates for manufacturers. Last minute preparations may attract unanticipated results. Instead, plan ahead for successful compliance. To win the race, look out for experts that can provide end-to-end labeling services and help you align with new guidelines, in time.