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MDL

Health Canada gibt Medizinprodukte-Lizenzen bald elektronisch aus

Die kanadische Medizinprodukte-Behörde Health Canada plant, neue und geänderte Betriebsbewilligungen für Medizinprodukte (Medical Device Establishment License, MDEL) und Medizinprodukte-Lizenzen (Medical Device Licenses, MDL) ab 1. November 2013 nur mehr auf elektronischem Weg auszustellen. 

Laut einer E-Mail von Health Canadas Medizinprodukte-Abteilung werden neue oder geänderte Lizenzen nicht mehr in Papierform an Medizinprodukte-Hersteller versandt, um die Arbeitsabläufe bei der Behörde zu verbessern. 

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.

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.

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:

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.)