Year of Version: Date of Text (Issued): May 7, Type of Text: Implementing Rules/Regulations. Subject Matter: Enforcement of IP and Related Laws. List of medical device regulatory documents published by Health Canada. We also can Canadian Medical Devices Regulations, en, SOR , 02/ Amendments to the Medical Devices Regulations (SOR 98/) of February 13, made by the Canadian Regulatory Authority, Health.
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It includes a change to any of the following:. Information is outdated or wrong.
CANADA: amendments to SOR 98/282 came into force
Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing. The objectives of the Act are to prevent young persons from accessing cannabis, to protect public health and public safety by establishing strict product safety and product quality requirements, and to deter criminal activity by imposing serious criminal penalties for those operating outside the legal framework. IVDD used to identify or infer the identity of a cultured microorganism.
It has a spelling mistake. The Act prohibits a number of activities pertaining to assisted reproduction and related research, including cloning, in vitro embryo sex selection and payment for surrogacy. The following new regulations will come into force at the same time as the Cannabis Act, on October 17, Special Rules Rule 6: A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device.
Some of the prohibited activities can be carried out if done in accordance with regulatory requirements that pertain to consent, testing donated sperm and ova for health and safety risks, and reimbursement of expenditures related to gamete donation and surrogacy. Other Uses Rule 4: Radiation Emitting Devices Regulations C.
CANADA: Amendments to SOR 98/ came into force
This Act creates a strict legal framework for controlling the production, distribution, sale, importation, exportation, and possession of cannabis across Canada. Cannabis Regulations Industrial Hemp Regulations Qualifications for Designation as Analyst Regulations Cannabis Controlled Drugs and Substances Act This Act provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Login error when trying to access an account e.
Active Devices Rule 8: Except as authorized by regulation or via an exemption issued under Section 56 of the Act, all activities involving substances listed in the Schedules to the Act, i.
Skip to main content Skip to “About this site” Skip to section menu. Microbiological media used to identify or infer the identity of a microorganism. Sections 90, 92, and of the Act authorize the Minister of Health to: Any medical device that is a material intended to be sold to a health care professional or dispenser for the specific purpose of configuration or arrangement into a mould or shape to meet the needs of an individual is classified in the class that applies to the finished medical device.
Non-invasive Devices Rule 4: My Service Canada Account.
Thank you for your help! Please select all that apply: Pesticides include a variety of products such as insecticides, herbicides and fungicides for use in agriculture, forestry, industry and households. You will not receive a reply. A link, button or video is not working.
Report a problem or mistake on this page. I can’t find what I’m looking for. Special Rules Rule Update Administrative Burden Baseline update This Act and the Regulations protect human health and the environment through a pre- and post-market evaluation program to prevent unacceptable risks.
It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in regulationa facilities.
The Minister of Health may appoint inspectors who are empowered to search premises and to seize and detain devices, and may appoint analysts to analyse or examine radiation emitting devices and packaging.
List of Acts and Regulations. Other issue not in this list. Tissue expanders for breast reconstruction and augmentation. Near patient in vitro diagnostic device for determining cholesterol level.
The Act and regulations ensure the safety of and prevent deception in relation to food, drugs, cosmetics and medical devices by governing their sale and advertisement. I,certify that I have knowledge of all matters contained in this certificate and that.
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