EMERGO SUMMARY OF KEY POINTS:

• Health Canada has raised Medical Device License (MDL) and amendment application review fees effective April 1, 2017.
• Canadian MDL and amendment review fees increase by two percent each year.

Canada’s medical device market regulator Health Canada has enacted increased fees for Medical Device License (MDL) application reviews effective April 1, 2017.

The regulator published its new fee schedule (section 4 of the document) for Class II, III and IV new and amended MDL applications; Health Canada increases its review fees by two percent every year.

• Class II New License Application: $397
• Class III New License Application:  $5,691
• Class III New License Application for near-patient IVD: $9,687
• Class III Amendment Application with significant manufacturing changes: $1,433
• Class III Amendment Application with significant changes affecting device class: $5,330
• Class IV New License Application: $13,235
• Class IV New License Application for devices with human/animal tissue: $12,347
• Class IV New License Application for near-patient IVD: $22,560
• Class IV Amendment Application with significant manufacturing changes: $1,433
• Class IV Amendment Application with significant changes affecting device class: $6,073

(All prices in Canadian dollars)

Canadian medical device market resources:

• Health Canada Medical Device License (MDL) and Medical Device Establishment License (MDEL) registration support
• Health Canada medical device classification support
• Whitepaper: Health Canada MDL preparation
• Video overview: Canadian medical device registration