{{ phone }} {{ location }}

Emergo by UL logo



Santé Canada établit un cadre règlementaire pour les logiciels à titre d'instruments médicaux (LIM)

Par Stewart Eisenhart


  • Santé Canada propose un cadre règlementaire pour les logiciels à titre de dispositifs médicaux (LIM).
  • Les règles proposées par Santé Canada pour les LIM sont établies d'après les lignes directrices du Forum international des instances de règlementation des DM (l'IMDRF).
  • La réglementation de Santé Canada sur les LIM exclurait les produits tels que les dossiers de santé électroniques et les applications de bien-être.

Health Canada Switching to Electronic Delivery of Medical Device Licenses

Canadian medical device market regulator Health Canada plans to issue only electronic versions of new and amended Medical Device Establishment Licenses (MDEL) and Medical Device Licenses (MDL) starting November 1, 2013. 

According to an email from Health Canada's Medical Devices Bureau, no more hard copies of new or amended licenses will be sent out to medical device manufacturers in order to boost process efficiencies at the regulator. 

Applicants for medical device licensing in Canada should be sure to include appropriate email addresses in their submissions in order to properly receive registration documents. Questions regarding this new policy can be sent to mdb_enquiries@hc-sc.gc.ca.

Final Guidance on Class III, IV Device Licensing from Health Canada

Health Canada has released final guidance on supporting evidence requirements for Class III and Class IVC medical device license applications. The guidance specifies scientific information requirements for manufacturers submitting Class III and Class IV device license applications, excluding makers of Class III and IV IVD products. (Health Canada plans separate updated guidance on higher-risk IVDs in the future.)

New Health Canada Fees Set for April 1, 2012

Canadian medical device regulator Health Canada plans to increase its fees to manufacturers starting April 1, Emergo Group’s Canada office has learned.

For Class II medical device license application reviews, fees will increase from $350 to $357.

For Class III medical device license application reviews, HC plans the following increases:

Health Canada Proposes Risk-Based Inspection Model

Health Canada is seeking comment from industry on a proposed risk-based inspection model for medical device manufacturers active in the Canadian market.

The regulator has requested comment specifically on how to assess individual medical device establishments’ risk, and on appropriate inspection cycles for varying levels of risk.