Meet Health Canada Requirements: Class I, II, III, or IV Medical & Surgical Devices/IVD/POCT-NPT/SaMD

How we can help:

With our team’s 2000+ projects & services and 25+ years in-depth Canadian market commercial and Health Canada regulatory expertise, we are fully positioned to help our clients from all over the world with virtually any project for the Canadian market. This includes meeting Health Canada requirements for any types of medical & surgical devices, in-vitro diagnostic devices (IVD), Point-of-care or Near-patient-testing (POCT-NPT) devices, and Software as a Medical Device (SaMD) products. We have extensive experience and proven expertise in helping our global clientele develop and implement overall regulatory strategic plans to meet Health Canada requirements. We have experience with most kinds of Class I, II, III, or IV medical & surgical devices, IVDs, POCT-NPT, and SaMD across a very wide range of product categories and medical or biotech technologies.

Our Health Canada regulatory services include: 

Background:

Health Canada is the Government of Canada’s federal institution with responsibility for regulating medical devices in Canada, which it delivers through its internal offices of Therapeutic Products Directorate and Medical Devices Bureau. 

The Canadian regulatory environment is a dynamic landscape with Health Canada taking ongoing steps to further ensure the safety, effectiveness and quality of the medical devices used by Canadians. For example, Health Canada has developed an action plan to accelerate its efforts to strengthen the regulation of medical devices in Canada, and to better ensure optimal health outcomes for Canadians.

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