MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023

MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023

Health Canada


PMRA Annual Fees reduced for Reporting and Applications:

Health Canada is implementing a new approach beginning April 1, 2023. The PMRA will no longer contact registrants who fail to submit their volumetric sales report by the June 1st deadline. Registrants who do not submit their volumetric sales report by the June 1st deadline will face the Pest Control Products Act (PCPA) enforcement actions, which may include warning letters, compliance orders, court orders, and a recommendation to the Public Prosecution Service of Canada for prosecution.

PMRA sent a one-time notice to Registrant Contacts in mid-February this year to finish the Sales report for the 2022 calendar year.

PMRA charges an annual fee of approximately $4,000 per registration. If the Registrants have made fewer sales, they may be eligible for lower annual fees. This year, PMRA will send Annual Charge Packages to registrants at the end of February. The application deadline for reduced fees is April 1st, 2023. As of April 1st, 2023, Medical Device fees will be Increasing. 

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

We also have regulatory solutions for; OTC drugs, DIN Numbers, DEL, Veterinarian products, Food, and more.

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