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Don’t Get Tied up in Regulatory Red Tape
Count on DSA Consultants to Meet all Your Medical Devices Regulatory Needs.

  • Helping clients across the globe market their healthcare products in Canada
  • Helping you navigate the Canadian Regulatory Framework.
  • We are recognized leaders in Canadian Regulatory Consulting
  • Use our services on a full-time, part-time, or as needed basis.

This competitive healthcare field demands keeping on top of regulatory compliance to ensure your position in the market place. You can’t afford costly delays while dealing with regulatory and licensing issues.

That’s why it makes good business sense to have DSA Consultants cut through the red tape of Health Canda for you, quickly and effectively… and help give you a competitive edge.

What is a Medical Device?

The sale of Medical Devices in Canada is regulated by the Medical Devices Regulations which are part of the Food and Drug Regulations. The Canadian Food and Drugs Act defines a Medical Device as follows:

"device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

  • (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms ,in human beings or animals,
  • (b) restoring, correcting or modifying a body function or the body structure of human beings or animals,
  • (c) the diagnosis of pregnancy in human beings or animals, or
  • (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug;

With respect to Medical Devices, we offer a wide range of services for;

Contact us today to find out how we can help you navigate the Canadian Regulatory Framework with respect to Medical Device products. For more information on services offered, click here to request a copy of our free brochure.

Risk Assessment & Product Registrations Labelling Establishment Licensing & HPFBI Inspections Complaints & Mandatory Problem Reporting

Risk Assessment & Product Submissions

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Labelling

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Establishment Licensing & HPFBI Inspections

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Complaints & Mandatory Problem Reporting

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