CANADIAN MEDICAL DEVICE REGULATIONS SOR 98-282 PDF

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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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

Near patient in vitro diagnostic device for determining cholesterol level. You will not receive a reply. 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.

Information is outdated or wrong. This Act and the Regulations protect human health and the environment through a pre- and post-market evaluation program to prevent unacceptable risks.

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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.

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Sections 90, 92, and of the Act authorize the Minister of Health to: Please select all that apply: Login error when trying to access an account e.

Thank you for your help! Other Uses Rule 4: It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

The following new regulations will come into force at the same time as the Cannabis Act, on October 17, 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.

Special Rules Rule 6: Report a problem or mistake on this page.

It includes a change to any of the following:. Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing. Pesticides include a variety of products such as insecticides, herbicides and fungicides for use in agriculture, forestry, industry and households. Update Administrative Burden Baseline update Microbiological media used to identify or infer the identity of a microorganism.

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Active Devices Rule 8: Other issue not in this list.

Medical Devices Regulations

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. Radiation Emitting Devices Regulations C.

IVDD used to identify or infer the identity of a cultured microorganism. I can’t find what I’m looking for.

CANADA: amendments to SOR 98/282 came into force

Non-invasive Devices Rule 4: 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. 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 rrgulations risks, and reimbursement of expenditures related to gamete donation and surrogacy.

This Act creates a strict legal framework for controlling the production, distribution, sale, importation, exportation, and possession of cannabis across Canada.