While e-labeling will not happen anytime soon in Europe, Health Canada has recently given its go-ahead to alternative labeling.
The two-month-old notice provides a new interpretation of Canada's Medical Devices Regulations and allows for electronic labeling of those medical devices that are sold exclusively to medical professionals.
According to Emergo Group, the usual rules apply:
The usual rules apply: All medical devices must be labeled in order to be sold or imported, and all labels — including electronic ones — must be legibly and prominently displayed. Manufacturers now have the option of providing only e-labeling via CD or DVD for devices not sold to the general public. For Class IV medical devices and IVDs that do not fall under the "near patient IVDD" definition, label information may be provided in downloadable format from an "easily navigable" website.For further details, take a look at Health Canada's Notice.
Manufacturers using e-labeling are obliged to provide paper copies of that information upon request to device users. Furthermore, manufacturers must provide attestations that e-label details match word-for-word those included on the paper labels of their devices.
Before you leave, take a look at the following related articles:
- When will e-labeling become reality for devices?
- Mind your language! Bilingual packaging, branding in Canada
- Once seen as Holy Grail, elabeling provides new challenges
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