CANADIAN MEDICAL DEVICE REGULATIONS SOR 98-282 PDF

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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Tissue expanders for breast reconstruction and augmentation. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

Return to footnote a S.

List of Acts and Regulations –

Active Devices Rule 8: Please select all that apply: Radiation Emitting Devices Regulations C. Cannabis Regulations Industrial Hemp Regulations Qualifications for Designation as Analyst Regulations Cannabis Controlled Drugs and Substances Act 98-22 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.

Near patient in vitro diagnostic device for determining cholesterol level. Pesticides include a variety of products such as insecticides, herbicides and fungicides for use in agriculture, forestry, industry and households. Skip to main content Skip to “About this site” Skip to section menu. I,certify that I have knowledge of all 998-282 contained in this certificate and that.

Medical Devices Regulations

Except as authorized by regulation or via an exemption issued under Section 56 of the Act, all 998-282 involving substances listed in the Schedules to the Act, i. My Service Canada Account. 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. A medical device that canaeian or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device.

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It includes a change to any of the following:.

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.

IVDD used to identify or infer the identity of a dsvice microorganism.

List of Acts and Regulations

Thank you for your help! Information is outdated or wrong. Non-invasive Devices Rule 4: Sections 90, 92, and of the Act authorize the Minister of Health to: It has a spelling mistake. A link, button or video is not working. Login error when trying to access an account e. Other issue not in this list. 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.

CANADA: amendments to SOR 98/282 came into force

Other Uses Rule 4: The objectives of the Cannadian 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. This Act creates a strict legal framework for controlling the production, distribution, sale, importation, exportation, and possession of cannabis across Canada.

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Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing. 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, I can’t find what I’m looking for. You will not receive a reply.

Any medical device that is a material intended to be sold to a health care professional or dispenser for the specific purpose rgeulations 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 medival device.

Microbiological media used to identify or infer the identity of a microorganism. Special Rules Rule 6: 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. Special Rules Rule Report a problem or mistake on this page.

List of Acts and Regulations.