Our Services我们的服务

End-to-end support for medical device market entry and cross-border distribution.医疗器械市场准入和跨境分销的一站式服务。

Canadian Market Entry Process加拿大市场准入流程

A simplified overview of bringing medical devices to Canada医疗器械进入加拿大的简化流程

1

Classification分类

Device Class I-IV based on risk根据风险等级分为I-IV类

2

Manufacturer Prep制造商准备

MDSAP + MDL (Class II+)MDSAP + MDL（II类及以上）

3

Import Setup进口设置

CARM Portal + CustomsCARM门户 + 海关

4

Distribution分销

Bilingual labels + Compliance双语标签 + 合规

Import & Distribution进口与分销

We help international manufacturers bring their medical devices into the Canadian market through our licensed distribution network.我们帮助国际制造商通过我们的授权分销网络将其医疗器械引入加拿大市场。

  • ✓Licensed MDEL holder for medical device imports持有医疗器械进口MDEL许可证
  • ✓Warehousing and logistics coordination仓储和物流协调
  • ✓Distribution partnerships with healthcare facilities与医疗机构建立分销合作
  • ✓Bilingual labeling compliance双语标签合规
Import & Distribution

Export Services出口服务

Canadian manufacturers can leverage our international network to reach new markets in Asia, Middle East, Africa, and beyond.加拿大制造商可以利用我们的国际网络进入亚洲、中东、非洲及其他市场。

  • ✓Market entry to China, Turkey, India, and more进入中国、土耳其、印度等市场
  • ✓Export documentation and compliance support出口文件和合规支持
  • ✓International partner sourcing国际合作伙伴开发
  • ✓Certificate of Free Sale facilitation自由销售证书协助
Export Services

Regulatory Consulting法规咨询

Navigate Health Canada's regulatory requirements with expert guidance from professionals who understand both the technical and practical aspects of device certification.在了解设备认证技术和实践方面的专业人员指导下，顺利完成加拿大卫生部的法规要求。

  • ✓Medical Device License (MDL) guidance医疗器械许可证(MDL)指导
  • ✓Device classification (Class I, II, III, IV)设备分类(I、II、III、IV类)
  • ✓Quality Management System (QMS) preparation质量管理体系(QMS)准备
  • ✓Documentation review and gap analysis文件审核和差距分析
Regulatory Consulting

Clinical Trial Support临床试验支持

We conduct and assist with clinical trials for medical devices, providing end-to-end research management from study design to regulatory submission.我们为医疗器械进行和协助临床试验，提供从研究设计到法规提交的一站式研究管理。

  • ✓Clinical trial design and protocol development临床试验设计和方案制定
  • ✓Site selection and patient recruitment试验点选择和患者招募
  • ✓Data collection and statistical analysis数据收集和统计分析
  • ✓Regulatory submission support法规提交支持
Clinical Trial Support

Markets We Serve我们服务的市场

Connecting medical device markets across the globe连接全球医疗器械市场

🇨🇦 🇺🇸 🇪🇺 🇬🇧 🇨🇳 🇹🇷 🇮🇳 🇰🇷 🇳🇦

Canada, USA, European Union, UK, China, Turkey, India, South Korea, Namibia加拿大、美国、欧盟、英国、中国、土耳其、印度、韩国、纳米比亚

Ready to Get Started?准备好开始了吗？

Contact us to discuss your specific needs and how we can help you enter new markets.联系我们，讨论您的具体需求以及我们如何帮助您进入新市场。

Contact Us联系我们