MDEL

Health Canada Proposing Major Fee Increases for Medical Device License Applications

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada wants to implement Medical Device License application fee increases for Class II, III and IV medical device registrants.
  • MDL fees have not been significantly adjusted since 2011, according to Health Canada.
  • If implemented, these major MDL fee increases could complicate Canadian market entry for many medical device companies.

Health Canada Extends Compliance Deadline for Commercially Reprocessed Medical Devices

Health Canada, the Canadian medical device market regulator, plans to extend its deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses and meet market authorization requirements, according to the agency.

3 Ways Health Canada Could Simplify Compliance for Medical Device Companies

I have prepared hundreds of medical device submissions for Health Canada over the years. Low risk devices, high risk devices and everything in between.  While Health Canada offers a well-documented path to compliance and is generally very competent, there are some keys areas that continue to confound device companies and that could be improved.

Latest Information on Health Canada Review and Approval Times for MDEL Applications

Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted Health Canada under Canada’s Access to Information Act asking for the following information:

Health Canada Inspection Report: High CMDR Compliance Rates for Medical Device Establishment License Holders

A new Health Canada report on regulatory inspections of domestic and foreign medical device companies active in the Canadian market has shown a 98% overall compliance rate among importers, manufacturers and distributors.

Health Canada inspected a total of 2057 Medical Device Establishment License (MDEL) holders over the course of the regulator’s 2012-2013 fiscal year, citing 3251 observations of noncompliance with various sections of the Canadian Medical Device Regulations.

Most common observations cited involved documentation issues (section 45(g) of the CMDR); recall procedures (section 58(b)); and investigation procedures (section 58(a)).

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: Export Equals Sale of Medical Devices

Health Canada official has informed Emergo Group that Canadian medical device manufacturers should consider exports of their products as sales when calculating revenues and determining Medical Device Establishment License (MDEL) fees.

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:

HC Amends Procedure for Mandatory Problem Reports

Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Progra

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