HC Makes Some Allowances for Paperless Medical Device Labeling

Health Canada has issued a new interpretation of Canada’s Medical Devices Regulations allowing electronic labeling for medical devices sold exclusively to medical professionals.

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.

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.

The e-labeling interpretation went into effect immediately upon its issuance on November 9, 2010.

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