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CMDCAS

Health Canada

Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety.

Working together with other levels of government, health care professionals, patient and consumer interest groups, research communities and manufacturers, our department endeavors to minimize the health risk factors to you and maximize the safety provided by the regulatory system for these products.

They also strive to provide you with the information you need to make healthy choices and informed decisions about your health.

Health Canada is not a manufacturer or distributor of drugs and health products. They are the federal regulator. For additional drug information related to treatment options or where drugs or health products are sold, please contact your health professional or the individual company directly.

What is Available?

Health Canada is committed to providing timely access to sound, evidence-based information. They want to ensure that Canadians remain up-to-date on current developments and issues pertaining to drugs and health products in Canada.

Medical Device

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet "Safe Medical Devices in Canada".

Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada

The Therapeutic Products Directorate (TPD) undertakes a variety of activities including the making of policies or regulations to support its role as the federal regulatory authority for the sale of pharmaceutical drugs and medical devices in Canada. These activities are carried out with the participation of clients, stakeholders and the general public.

MD manufacturers must receive a medical device license for certain health products defined as a "device" under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a license, all medical devices have been categorized based on the risks associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license. Although Class I devices do not require a license, manufacturers, distributors and importers are required to obtain an establishment license.

MD may also require certification by the Canadian Nuclear Safety Commission (CNSC) prior to licensing for operational or servicing activities.

What We Do?

--Gap analysis audit

--Pre-assessment audit

--Full or partial internal audit

--Subcontractor or supplier audit

--Document and records control

--Training on regulatory requirements and internal procedures

--Design and development

--Risk management

--Software development (if applicable)

--Supplier evaluation

--Control of measurement equipment 

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".

Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS) - Quality Systems.pdf