医疗器械出口加拿大指南：MDEL认证全解析
为什么选择加拿大市场？ 加拿大作为全球重要的医疗器械市场之一，其监管体系完善且市场规范。对于想要拓展北美市场的中国医疗器械企业来说，加拿大是一个理想的起点。
Why choose the Canadian market? As one of the world's important medical device markets, Canada has a well-established regulatory system and standardized market. For Chinese medical device companies looking to expand into the North American market, Canada is an ideal starting point.
加拿大医疗器械监管体系 加拿大卫生部(Health Canada)负责医疗器械的监管工作。所有在加拿大销售的医疗器械，无论是本地生产还是进口，都必须获得加拿大卫生部的许可。
Canadian medical device regulatory system Health Canada is responsible for the regulation of medical devices. All medical devices sold in Canada, whether domestically produced or imported, must obtain authorization from Health Canada.
医疗器械分类
Medical Device Classification
加拿大根据风险程度将医疗器械分为4类：
Canada classifies medical devices into 4 categories based on risk level:
- I类：低风险
- II类：中低风险
- III类：中高风险
- IV类：高风险
- Class I: Low risk
- Class II: Medium-low risk
- Class III: Medium-high risk
- Class IV: High risk
MDEL认证要求
MDEL Certification Requirements
所有医疗器械在加拿大销售都需要获得医疗器械销售许可证(MDEL)。但以下情况可以豁免：
All medical devices require a Medical Device Establishment License (MDEL) to be sold in Canada. However, the following situations are exempt:
- 经销商
- 医疗机构
- 销售自有II、III、IV类医疗器械的生产商
- 通过持有MDEL的企业销售I类医疗器械的生产商
- Distributors
- Healthcare institutions
- Manufacturers selling their own Class II, III, and IV medical devices
- Manufacturers of Class I medical devices selling through MDEL holders
MDEL有效期
MDEL Validity Period
MDEL没有固定有效期，但持有人必须在每年4月1日前提交年度审核申请，否则许可证将被撤销。
MDEL does not have a fixed validity period, but holders must submit an annual review application before April 1 each year, otherwise the license will be revoked.
认证流程
Certification Process
I类医疗器械：
Class I Medical Devices:
- 准备MDEL申请技术文件
- 提交MDEL申请并支付费用
- 通过评审后在官网公示
- Prepare technical documents for MDEL application
- Submit MDEL application and pay fees
- After approval, it will be published on the official website
II-IV类医疗器械：
Class II-IV Medical Devices:
- 通过CMDCAS认可的机构进行ISO 13485认证
- 准备MDL申请材料
- 提交申请并支付费用
- 通过评审后在官网公示
- Obtain ISO 13485 certification from a CMDCAS-recognized organization
- Prepare MDL application materials
- Submit application and pay fees
- After approval, it will be published on the official website
重要提示：医疗器械出口审查严格，建议企业在出口前充分了解认证要求，避免不必要的损失。
Important Note: Medical device export reviews are strict. It is recommended that companies fully understand certification requirements before exporting to avoid unnecessary losses.
