加拿大医疗器械注册费用汇总
在申请加拿大的医疗器械企业许可证（Medical Device Establishment Licence，以下简称MDEL）或医疗器械许可证（Medical Device Licence ，以下简称MDL）时，申请费用是企业最为关心的问题之一。
小编根据加拿大法规（Canadian Medical Device Regulation）以及Health Canada颁布的指南文件，汇总了加拿大医疗器械相关注册费用（含小企业优惠），具体如下：
| 序号 | 类型 | 2023年4月1日起 | 小微企业身份减免后 | 2024年4月1日起 | 小微企业身份减免后 |
| 1.MDEL | |||||
| 1 | 初次申请/ New Application | $5,060 | $3,795 | $5,283 | $3,962.25 |
| 2 | MDEL年审/Annual Licence Review of MDEL | $5,060 | $3,795 | $5,283 | $3,962.25 |
| 3 | 激活证件/Reinstatement | $5,060 | $3,795 | $5,283 | $3,962.25 |
| 4 | 行政变更/Notification | $0 | / | / | / |
| 5 | 产品变更等（除行政变更外）/Amendment(not captured under a notification) | $0 | / | / | / |
| 6 | 注销证件/Suspended | $0 | / | / | / |
| 2.MDL | |||||
| 1 | Class II初次申请/Applications for Class II licence | $589 | $441.75 | $615 | $461.25 |
| 2 | ClassII变更申请、授权变更/Applications for Class II licence amendment or applications to amend Class II authorization | $302 | $226.5 | $316 | $237 |
| 3 | Class III初次申请/Applications for Class III licence | $12,987 | $9,740.25 | $13,559 | $10,169.25 |
| 4 | Class III初次申请（近患者）/Applications for Class III licence (near patient) | $27,666 | $20,749.5 | $28,884 | $21,663 |
| 5 | ClassIII变更申请、授权变更（生产信息变更）/Applications for Class III licence amendment or applications to amend Class III authorization – changes in manufacturing | $4,098 | $3,073.5 | $4,279 | $3,209.25 |
| 6 | ClassIII变更申请、授权变更（非生产信息的重大变更）/Applications for Class III licence amendment or applications to amend Class III authorization – significant changes not related to manufacturing | $10,425 | 7,818.75 | $10,884 | $8,163 |
| 7 | Class IV初次申请/Applications for Class IV licence | $28,165 | $21,123.75 | $29,405 | $22,053.75 |
| 8 | ClassIV变更申请、授权变更（生产信息变更）/Applications for Clarization– changes in manufacturing | $4,098 | $3,073.5 | $4,279 | $3,209.25 |
| 9 | ClassIII变更申请、授权变更（非生产信息的重大变更）/Applications for Class IV licence amendment or applications to amend Class IV authorization – significant changes not related to manufacturing | $14,902 | $11,176.5 | $15,558 | $11,668.5 |
| 10 | 自有品牌初次申请、变更申请、授权变更/Applications for Class II, III or IV licence, applications to amend such a licence or applications to amend Class II, III or IV authorization – private label medical device | $163 | $122.25 | $171 | $128.25 |
| 11 | MDL年审 | $421 | $315.75 | $440 | $330 |
| 3.小微企业 | |||||
| 1 | 免费：第一次进行上市前评估提交/申请/行政变更their first ever Pre-market Evaluation submission / application / notification for free | ||||
| 2 | 所有上市前评估费用减免50%50% reduction for all Pre-market Evaluation fees | ||||
| 3 | 所有年审费减免25%25% reduction for all Right to Sell fees | ||||
| 4 | 所有企业证件费减免25%25% reduction for all Establishment Licence fees | ||||
备注：如本文内容与加拿大法规不一致，以加拿大法规和官方公布的信息为准。
参考法规及链接：
（1）MDEL申请费用
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-establishment-licence-funding-fees-drugs-health-products.html
（2）MDL申请费用
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
（3）MDEL年审费用
“2. The MDEL fee for new and annual licence review applications
The MDEL fee is a flat fee regardless of when in the fiscal year the application is received. The Government of Canada’s fiscal year begins on April 1 and ends on March 31 of the subsequent year. The same fee applies to the following types of applications:
1.an application for a new MDEL.
2.an application for the reinstatement of a suspended MDEL.
3.an application for the Annual Licence Review (ARL) of an MDEL.”
——摘自Health Canada《Fees for the Review of Medical Device Establishment Licence Applications》
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-medical-device-establishment-licence.html
（4）MDL年审费用
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-licensed-class-medical-devices-funding-fees-drugs.html%EF%BC%89
（5）小微企业
“As of April 1, 2020, qualifying small businesses will receive:
1.their first ever Premarket Evaluation submission/application/notification for free.
2.50% reduction for all Pre-market Evaluation fees.
3.25% reduction for all Right to Sell fees.
4.25% reduction for all Establishment Licence fees.”
摘自：Health Canada
《Small business mitigation for drugs and medical devices: Small business fee reduction measures》
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/small-business-mitigation.html
