CANADIAN MEDICAL DEVICE REGULATIONS SOR 98-282 PDF

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His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3 3 , 30 1 and 37 1 a of the Food and Drugs Act , hereby makes the annexed Medical Devices Regulations. 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.

It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. It includes a change to any of the following:. 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.

I, , certify that I have knowledge of all matters contained in this certificate and that. Back to top. Current version: in force since Dec 16, Link to the latest version :. Stable link to this version :. Citation to this version:.

This regulation is current to according to the Justice Laws Web Site. Expand All. Interpretation [ 1 ]. Application [ 2 - 5 ]. Classification of Medical Devices [ 6 - 7 ]. PART 1 — General [ 8 - 68 ]. Application [ 8 ]. Safety and Effectiveness Requirements [ 10 - 20 ]. Labelling Requirements [ 21 - 23 ]. Contraceptive Devices — Advertising [ 24 ]. Class I Medical Devices [ 25 ]. Prohibition [ 26 - 27 ]. Medical Devices Deemed Licensed [ 28 - 31 ].

Application for a Medical Device Licence [ 32 ]. Quality Management System Certificate [ Foreign Manufacturers [ 33 ]. Application for a Medical Device Licence Amendment [ 34 ].

Additional Information and Samples [ 35 ]. Issuance [ 36 - 37 ]. Refusal to Issue [ 38 ]. Additional Information [ 39 ]. Suspension [ 40 - 42 ]. Obligation to Inform [ 43 ]. Obligation to Submit Certificate [ Application [ Notices to Commissioner of Patents [ Marking and Labelling [ Notice to Minister [ Establishment Licence [ 44 - Prohibition [ 44 ]. Application [ 45 ].

Issuance [ 46 ]. Annual Review of Licence [ Refusal [ 47 ]. Notification [ 48 ]. Suspension [ 49 - 51 ]. Cancellation [ Distribution Records [ 52 - 56 ]. Complaint Handling [ 57 - 58 ]. Mandatory Problem Reporting [ 59 - Provision of Information Under Section Recall [ 63 - Implant Registration [ 66 - 68 ]. Application [ 69 ]. General [ 70 ]. Authorization [ 71 - 72 ].

Additional Information [ 73 - 74 ]. Labelling [ 75 ]. Distribution Records [ 76 ]. Reporting an Incident [ 77 ]. Implant Registration [ 78 ].

Application [ 79 ]. General [ 80 ]. Records [ 81 ]. Authorization [ 82 - 83 ]. Additional Information [ 84 - 85 ]. Labelling [ 86 ]. Advertising [ 87 ]. Other Requirements [ 88 ]. Transitional Provisions [ 93 - 95 ]. Repeal [ 96 ]. Coming into Force [ 97 ]. Access version in force :. No amending legislation available on CanLII. You can search for documents citing this regulation on CanLII Noteup any citation to this regulation Noteup a specific section or subsection from this regulation:.

Citing or noting up a specific section or subsection If the present regulation has a "Show Table of Contents" button, you will see that each section and subsection number is displayed with a link offering you convenient citation and noteup tools that are specific to each provision.

You may want to use these tools instead of the above search box. Rule 15 : 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.

Tissue expanders for breast reconstruction and augmentation. Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing.

Near patient in vitro diagnostic device for determining cholesterol level. Microbiological media used to identify or infer the identity of a microorganism.

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

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List of Acts and Regulations

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3 3 , 30 1 and 37 1 a of the Food and Drugs Act , hereby makes the annexed Medical Devices Regulations. 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. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. It includes a change to any of the following:. 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. I, , certify that I have knowledge of all matters contained in this certificate and that. Back to top.

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CANADA: amendments to SOR 98/282 came into force

You will not receive a reply. Skip to main content Skip to "About government" Skip to section menu. List of Acts and Regulations. 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. 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. 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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