When is a device considered "sold to the general public?"

[Chris Ford]

Hi All,

In reference to "SOR 98/282; 23(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," I'm looking for an interpretation of the labeling requirements.

Effective eyeglass lenses can't be purchased without a licensed doctor's examination, however a prescription is not required to purchase eyeglasses in Canada.

Does this imply that a manufacturer is selling eyeglasses directly to the general public?

In Canada the MDR requires that the directions for use of devices sold to the general public be written in both French and English. I take this to mean that any over the counter device sold in Canada bear labeling in both languages, but a device is not technically sold to the general public, if the only way for the person to know what to buy is by having an exam done first.

I would appreciate any insight on this interpretation.

 

[MIREGMGR]

My understanding of HC's intent was to distinguish devices for which the end use was to be controlled by a consumer, from those for which the end use was to be controlled by a medical-professional user. (Note: user, not dispenser or prescriber.) The IFU for the consumer device would have to be provided in either language because a significant number of consumers are monolingual.

So, eyeglasses would be consumer; surgical drapes would be medical-professional user.

That's the gist of the distinction similarly made by US FDA, using different wording, in their regulations that govern the different treatment of IFUs for consumer and medical-professional.

 

[Chris Ford]

Thanks! I should clarify that a prescription isn't necessary only in British Columbia - that doesn't apply to the rest of Canada.

I get where you're coming from, and I understand why these requirements would be placed on the IFU. But then there isn't an IFU for eyeglasses. Manufacturers typically include care and cleaning instructions, along with warranty information. That's really thrown me off here.

Thanks again for your input... it helps put it in perspective for me, even though I think it's a silly rule to apply to eyeglasses!!