May 6, 2011

Health Canada has announced several changes to its licensing processes over the past several weeks, some of which have been reported previously by Emergo Group.

The following points summarize some of the major changes the regulator has implemented for the Canadian market.

First, Health Canada has repealed expiry dates for establishment licenses as of April 1, 2011. Licenses will no longer expire December 31 of each year—provided that manufacturers apply for annual reviews by April 1. Establishment licenses of firms failing to meet that deadline will become invalid.

Licenses for first-time applicants will have no expiration dates, but expiration dates will remain in place for annexes including Foreign Site, Alternate Sample Retention Site and Terms and Conditions. First-time license holders will also have to meet the April 1 deadline for annual review application submissions.

According to Health Canada, the 2012 annual review process begins this year; all establishment license holders will be sent notices to this effect. Firms receiving these notices should respond within 30 to 60 days so that Health Canada can issue all 2012 licenses by April of next year.

Manufacturers should note that Health Canada regulatory processes currently in place for Cells, Tissue, Organ registration as well as Manufacturers Certificate of Export for Medical Devices have not been changed.

Second, Health Canada has established performance standards for issuance of establishment licenses. For medical device licenses, tracking of these standards begins on the date of acceptance of a license application and lasts for 120 days.

Third, the regulator has launched initiatives to boost “cost recovery” and operating revenues. Revised and new user fees for medical device and drug establishment licenses, fee adjustments, payment deadlines and fee mitigation measures went into effect April 1.

In addition, applicant firms that have conducted activities under establishment licenses for one year must submit payment, fee forms, completed calculation charts and certified statements along with their applications in order to qualify for fee remission consideration. For applicants whose conducting activities have not lasted an entire year under license, payments will be deferred for one year.

Additional information is available here and here.


  • Stewart Eisenhart