On November 9, Health Canada’s Therapeutic Products Directorate (TPD) issued a permissive notice immediately authorizing device manufacturers of certain categories of devices to provide, in electronic format instead of paper format, the information ordinarily found in the directions for use pursuant to Section 21(1)(i) of the Canadian Medical Devices Regulations.
The permissive notice applies only to medical devices NOT SOLD TO THE GENERAL PUBLIC. This means devices only sold to, and intended for use by, a healthcare professional; and devices that are in vitro diagnostic devices (IVDD’s) that are NOT “near patient” IVDD’s.
The permitted e-labeling formats are Compact Disk (CD) or Digital Video Disk (DVD). The CD/DVD should be easily navigable, must be clearly labeled as to its purpose, and is to accompany the device at the time of sale or delivery.
TPD has also provided an additional e-labeling alternative for two subcategories of devices not sold to the general public: Class IV devices and IVDD’s that are NOT “near patient” IVDD’s. For these subcategories, the directions for use may alternatively be provided in downloadable format from the internet assuming certain conditions are met.
The Letter of Attestation modeled in the TPD Notice is to be completed and filed in the Manufacturer’s Quality Management System, and made available for review upon request by Health Canada, a CMDCAS Registrar, or a customer.
Directions for use submitted with Medical Device License Applications must still be submitted in paper format.
Click here for a link to the permissive Notice.