A look at what’s new with the Medical Devices Regulations and Canada Consumer Product Safety Act.

E-Labelling of Specified Medical Devices

The Therapeutics Product Directorate has issued a new interpretation of the Medical Devices Regulations with respect to electronic labelling of certain medical devices.

The affected devices, the directions for use that are required pursuant to the labelling requirements in the Regulations may be provided to users via an internet download or an electronic data storage device (e.g., disk, USB drive, etc.). Paper copies of the label information must be available and provided to users, upon request, without additional cost.

Manufacturers relying on such electronic labels must ensure that they are identical to any paper label submitted with the device licence application.

Please note that this interpretation applies only to devices that are not sold to the general public.

Health Canada’s full Notice and a sample Letter of Attestation can be found here.

Cosmetic Contact Lenses to Be Held To Medical Device Safety Standards

New regulations have been announced, which will make non-corrective contact lenses subject to the Medical Devices Regulations as of July 16, 2016.

Cosmetic contact lenses have been regulated as consumer products, but the amendments to the Regulations will be regulated as Class II medical devices. However, because cosmetic contact lenses do not have any therapeutic function, they will not be subject to the effectiveness requirements that apply to other types of medical devices.

Read the Regulations and Regulatory Impact Statement here.

New Draft Cribs, Cradles and Bassinets Regulations

Health Canada has issued proposed regulations under the Canada Consumer Product Safety Act that would repeal and replace the existing Cribs, Cradles and Bassinets Regulations with a stated purpose of strengthening product standards and better aligning Canadian requirements with those in the US.

These include:

  • A prohibition on drop side cribs
  • Including performance requirements for accessories such as sleep or change table accessories that attach to cribs, cradles or bassinets
  • Changing performance requirements for a stability, crib slat strength, etc.
  • Prohibiting the use of occupant restraints on cribs, cradles, bassinets and sleep accessories

Read the proposed Regulation and Regulatory Impact Statement here.