Regulatory Open Forum

Hello,

Our device has obtained approval in Canada, and we have received a few orders from there. Are there any language requirements for the Instructions for Use (IFU)? Do we need to translate the IFU into both English and French? Additionally, is an electronic version of the IFU acceptable (e-IFU)? Thank you for your assistance.

Linda

Hi Linda,

Here is the relevant text from the CMDR regarding IFU language requirements:

"...23 (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French. (2) Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser. (3) In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French..." [emphasis added]

Here's a blog post addressing Health Canada's medical device e-labeling approach.  Although the Health Canada guidance document linked there may no longer be available on Health Canada's website (thus I've given it here in this thread for reference purposes), I haven't seen information from Health Canada to the contrary.

Hello,

Our device has obtained approval in Canada, and we have received a few orders from there. Are there any language requirements for the Instructions for Use (IFU)? Do we need to translate the IFU into both English and French? Additionally, is an electronic version of the IFU acceptable (e-IFU)? Thank you for your assistance.

Linda

Hi Kevin

Health Canada's basic Guidance for the Labelling of Medical Devices now contains rules for e-labelling.

Hi Linda,

Here is the relevant text from the CMDR regarding IFU language requirements:

"...23 (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French. (2) Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser. (3) In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French..." [emphasis added]

Here's a blog post addressing Health Canada's medical device e-labeling approach.  Although the Health Canada guidance document linked there may no longer be available on Health Canada's website (thus I've given it here in this thread for reference purposes), I haven't seen information from Health Canada to the contrary.

Hello,

Our device has obtained approval in Canada, and we have received a few orders from there. Are there any language requirements for the Instructions for Use (IFU)? Do we need to translate the IFU into both English and French? Additionally, is an electronic version of the IFU acceptable (e-IFU)? Thank you for your assistance.

Linda

Thank you Anne for your help which is always great. Please confirm if this is the guidance to which you refer.

Hi Kevin

Health Canada's basic Guidance for the Labelling of Medical Devices now contains rules for e-labelling.

Hi Linda,

Here is the relevant text from the CMDR regarding IFU language requirements:

"...23 (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French. (2) Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser. (3) In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French..." [emphasis added]

Here's a blog post addressing Health Canada's medical device e-labeling approach.  Although the Health Canada guidance document linked there may no longer be available on Health Canada's website (thus I've given it here in this thread for reference purposes), I haven't seen information from Health Canada to the contrary.

Hello,

Our device has obtained approval in Canada, and we have received a few orders from there. Are there any language requirements for the Instructions for Use (IFU)? Do we need to translate the IFU into both English and French? Additionally, is an electronic version of the IFU acceptable (e-IFU)? Thank you for your assistance.

Linda