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  • 1.  French language requirement in Quebec

    Posted 12-Apr-2021 00:50
    Dear All,

    In Canada, we know that English or French IFU is required for medical device and the version of the other language should be provided on request. 
    However, could you advise if French IFU is mandatory in Quebec or New Brunswick? 
    Also, is there difference between OTC product or professional use product?

    Thank you in advance for your great support!

    Regards,
    Iida

    ------------------------------
    Soichiro Iida
    Kyoto-Shi
    Japan
    ------------------------------


  • 2.  RE: French language requirement in Quebec

    Posted 13-Apr-2021 08:45
    Hi Iida,

    There is definitely a difference between OTC and professional use. For OTC you will absolutely need it in French to sell in Quebec (not sure about NEW Brunswick). I have previous experience where a company I worked for sold into Quebec for professional use and did not require the IFU in french however I think we got lucky.

    Keri

    ------------------------------
    Keri Froese RAC
    Manager Compliance & Regulatory Affairs
    Healthsign
    Ottawa
    Canada
    ------------------------------

    Original Message


  • 3.  RE: French language requirement in Quebec

    Posted 13-Apr-2021 08:54
    Hi Soichiro-san,
    Quebec and New Brunswick are governed by the same medical device regulations as the rest of Canada (despite the fact that the official language in Quebec is French, and the official languages in New Brunswick are both French & English).
    There are differences between OTC products (products sold to the general public) and professional use products (products not sold to general public).
    Labelling requirements are outlined in SOR-98-282 articles 21-23 (https://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf).

    For professional use products, the IFU needs to be provided in either English or French (at a minimum), and if provided in only one official language, it needs to be made available in the other official language as soon as possible upon request per Medical Devices Regulations (SOR-98-282) article 23 (1) and 23 (2).
    23 (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French.
    23 (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.

    For OTC products, the IFU needs to be provided in English and French (at a minimum) per Medical Devices Regulations (SOR-98-282) article 23 (3).
    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.

    Good luck!

    ------------------------------
    Nomi Steen
    Regulatory Affairs Associate
    Elkton MD
    United States
    ------------------------------

    Original Message


  • 4.  RE: French language requirement in Quebec

    Posted 13-Apr-2021 15:35

    Hi Lida,

     

    According to Section 23 of the Canadian Medical Devices Regulations, both English and French languages must be on the labels for devices sold to the general public (regardless of which province it is sold to).  For devices for "professional use", the labelling can be in one of the official languages (ie English or French), but if requested by the user to be provided in the other language, it should be provided within a reasonable time (which is considered a week).  Those are the federal regulatory requirements.

     

    Now, on the provincial level, I believe the French language laws are only applicable to Quebec (Bill 101), and these are not regulatory requirements, but rather language requirements.

     

    There are two labelling guidance documents for medical devices and in vitro diagnostic devices.

     

    Hope this helps,

     

    Shirley

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

     

    3470 Superior Court

    Oakville ON L6L0C4

    Canada

    www.innomar-strategies.com

     

    United in our responsibility

    to create healthier futures

     




    Original Message


  • 5.  RE: French language requirement in Quebec

    Posted 13-Apr-2021 19:32
    Dear Keri,
    Dear Nomi,
    Dear Shirley,

    Thank you so much for all the valuable advices! 

    It seems the regulation of Health Canada might takes precedence (sorry I don't know if it is the proper English word.) to Quebec state regulation if there is conflict between them.

    ------------------------------
    Soichiro Iida
    Kyoto-Shi
    Japan
    ------------------------------

    Original Message


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