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Service Offering

Health Canada logo
MDSAP - Medical Device Single Audit Program
  • FDA and Health Canada Regulatory Services
  • Regulatory and Classification Research and pre-submission
  • Medical Device Classification and Licensing
  • MDL, MDEL, MDSAP Program Compliance Services
  • Protocol Building and Submission (Clinical Trials)
  • Ethics Board Applications
  • MDEL Utilization For Importation of Medical Devices
  • Document Preparation and Submission
  • Regulatory Correspondent on behalf of Manufacturer
  • Product Development Services
  • Product Quality Control Services
  • FDA Product Registration Management
  • FDA ISO-13485 Certified Manufacturing Services
  • FDA 510(k) Generation, Review, and Submissions
Momentum Jets
Momentum Solutions
GN Transport
Canada USA Freight Services
CN Customs Brokerage Services
Air Trans Forwarding
  • Importation and Logistics Coordination
  • Customs Regulatory Consulting
  • Customs Clearance and Declarations
  • Ground, Air, and Sea Transport
  • Local Courier

Certifications and Standards

Six Sigma Certificate
CPIM Certificate
APICS Certificate
Security Expert
Health Canada Medical Device Establishment Licence
Dun & Bradstreet


About us

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MedCare Medical Devices Canada, headquartered in Vaughan, ON, is an FDA and Health Canada medical device regulatory consulting firm. We are an importer and a distributor specializing in the introduction of rapid diagnostics, point of care, telehealth, patient comfort, mobility and digital health products to Canadian and international markets.

At MedCare Medical Devices Canada our primary objective is to locate products that provide healthcare practitioners with "outside of the box", safer and more effective ways to perform the necessary patient care functions that are required every day in hospitals, medical clinics, long term care facilities and more.  Many of the products and services we represent may also be offered directly to consumers through a variety of channels, including but not limited to pharmacies, medical device distributors, eCommerce platforms and corporate wellness buying groups.

As a client and innovation-focused organization, we carry a range of experience that includes business analysis, sales and marketing, logistics and customs clearance and regulatory affairs.  This broad set of business skills is complemented by our team of local and international doctors, professors of medicine and clinical consultants.  The combination of experience and expertise that we bring to bear assists us and by extension our clients, in navigating difficult regulatory landscapes and the uncertainties that come with introducing medical products and services into new markets, both Canadian and international.

Contact Us

We would love to hear from you!


101 Freshway Dr, Unit 75
Concord, ON L4K 1R9

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