By Stewart Eisenhart, Emergo Group
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:
- License application: from $5,050 to $5151
- License application for near patient IVD device: from $8,600 to $8,772
- License amendment application for significant manufacturing change: from $1,270 to $1,296
- License amendment application for significant change affecting device classification: from $4,730 to $4,825
Fees for Class IV medical device license application reviews have also increased as follows:
- License application: from $11,750 to $11,985
- License application for device containing human/animal tissue: from $10,960 to $11,180
- License application for near patient IVD device: from $20,030 to $20,431
- License amendment application for significant manufacturing change: from $1,270 to $1,296
- License amendment application for significant change affecting device classification: from $5,390 to $5,498
Finally, Medical Device Establishment License (MDEL) fees are increasing from $7,200 to $7,344, and renewal fees will increase to $337 per year. HC will make new application and amendment forms available starting April 1. Emergo Group will provide further details as we get them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
