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:
Fee Type | 2022 fee’s | 2023 fee’s | |
1 | Applications for Class II licence | $522 | $589 |
2 | Applications for Class II licence amendment or applications to amend Class II authorization | $282 | $302 |
3 | Applications for Class III licence | $10,679 | $12,987 |
4 | Applications for Class III licence (near patient) | $20,723 | $27,666 |
5 | Applications for Class III licence amendment or applications to amend Class III authorization – changes in manufacturing | $3,070 | $4,098 |
6 | Applications for Class III licence amendment or applications to amend Class III authorization – significant changes not related to manufacturing | $8,780 | $10,425 |
7 | Applications for Class IV licence | $25,955 | $28,165 |
8 | Applications for Class IV licence amendment or applications to amend Class IV authorization– changes in manufacturing | $3,070 | $4,098 |
9 | Applications for Class IV licence amendment or applications to amend Class IV authorization – significant changes not related to manufacturing | $12,128 | $14,902 |
10 | Applications for Class II, III or Class IV licence, applications to amend such a license or applications to amend Class II, III or Class IV authorization – private label medical device | $152 | $163 |
11 | Medical Device Right to Sell Class II, III or IV | $394 | $421 |
12 | Application for a new licence and annual review of licence | $4737 | $5060 |
| Fee | Fee Amount in 2022-2023 (CAD $) | Fee Amount in 2023-2024 (CAD $) |
|---|---|---|
| Human use – Fabrication – Sterile dosage form | 43,171 | 46,221 |
| Human use – Importation | 31,688 | 35,688 |
| Human use – Fabrication – Non-sterile dosage form | 30,677 | 34,266 |
| Human use – Distribution | 15,691 | 18,215 |
| Human use – Wholesaling | 7,962 | 10,630 |
| Human use – Packaging/labelling | 6,255 | 6,681 |
| Human use – Testing | 4,129 | 5,514 |
| Human use – Building outside Canada (each) | 949 | 1,014 |
| Veterinary use – Fabrication – Sterile dosage form | 42,080 | 45,262 |
| Veterinary use – Importation | 17,278 | 23,066 |
| Veterinary use – Fabrication – Non-sterile dosage form | 14,161 | 18,905 |
| Veterinary use – Distribution | 7,797 | 10,409 |
| Veterinary use – Wholesaling | 3,117 | 4,161 |
| Veterinary use – Packaging/labelling | 6,255 | 6,681 |
| Veterinary use – Testing | 2,121 | 2,833 |
| Veterinary use – Building outside Canada (each) | 949 | 1,014 |
| Fee | Fee Amount in 2022-2023 (CAD $) | Fee Amount in 2023-2024 (CAD $) |
|---|---|---|
| Dealer’s Licence Fees – Human Drugs | 5,613 | 5,726 |
| Dealer’s Licence Fees – Veterinary Drugs | 1,882.52 | 2,010.53 |
| Dealer’s Licence Fees – Veterinary Drugs (first year) | 941.26 | 1,005.27 |
| Fee | Fee Amount in 2022-2023 (CAD $) | Fee Amount in 2023-2024 (CAD $) |
|---|---|---|
| New active substance | 490,666 | 565,465 |
| Clinical or non-clinical data and chemistry and manufacturing data | 253,015 | 292,806 |
| Clinical or non-clinical data only | 104,339 | 117,080 |
| Comparative studies | 59,708 | 65,985 |
| Chemistry and manufacturing data only | 34,831 | 40,597 |
| Clinical or non-clinical data only, in support of safety upgrades to the labelling | 20,064 | 21,429 |
| Labelling only | 4,997 | 5,901 |
| Labelling only (generic drugs) | 2,075 | 2,217 |
| Administrative submission | 698 | 933 |
| Disinfectant – Full review | 9,211 | 12,297 |
| Labelling only (disinfectants) | 2,588 | 2,764 |
| Drug identification number application – Labelling standards | 1,668 | 1,782 |
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.
