Canadian Regulator Updates Advice on Establishment Fees

January 2, 2015

Health Canada has issued guidance addressing frequently asked questions about medical device establishment licensing and fees.

The FAQ, posted to the agency’s website on Dec. 29, discusses important dates for MDELs and fees for any new establishment issued its first license during 2013. The fee is deferred until the end of the first full calendar year of activities under the license.

For example, an establishment whose first MDEL was issued Feb. 1, 2013, would have had its first annual review before April 1, 2014, and the fee and fee remission request fee would have been deferred until Dec. 31, 2014.

The following year, the annual review would again be before April 1 while the fee would be due at time of application and the fee remission request fee would be due with the application, the FAQ explains.

Health Canada will get in touch with establishments that have completed their first calendar year of activities and remind them to pay their fee and submit a fee remission request, if applicable.

The fee for an application submitted during the fiscal year that ends March 31, 2015, is $7,641. This is a flat fee for MDEL application reviews and increases by 2 percent each year.

Companies are eligible for a fee remission if their fees are greater than 1 percent of actual gross revenues from activities performed at the licensed establishment during the previous calendar year. A certified statement of revenue, signed by the firm’s chief financial officer, must be submitted in support of such requests.

The FAQ is available at www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/faq-eng.php. — April Hollis