CANADIAN MEDICAL DEVICE REGULATIONS SOR 98-282 PDF

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:.

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Forums New posts Search forums. Media New media New comments Search media. Resources Latest reviews New resources Search resources. Attachment List. Log in Register. Search titles only. Search Advanced search…. New posts. Search forums. Log in. For a better experience, please enable JavaScript in your browser before proceeding. Thread starter ryannh Start date Sep 18, Do you guys know why it updates yearly? Sep 19, There is also a clarification where "safety and effectiveness requirements" was replaced with "applicable requirements of sections 10 to You must log in or register to reply here.

Private Label? Canada Medical Device Regulations 3 Oct 25, Similar threads. May 2, Apr 2, Mar 13, Medical Device Misclassified by Health Canada. Sep 3, How to look up all Class 1 medical devices on sale in Canada. Aug 13, Informational Health Canada — Drug and medical device highlights Helping you maintain and improve your health. Jul 24, Jul 21, Jun 26, Informational Health Canada — Mandatory reporting requirements for hospitals.

Jun 18, Informational Health Canada launches consultations to improve the safety of medical devices. May 29, May 17, May 16, May 6, Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure. Apr 5, Apr 3, Mar 28, Mar 26, Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada.

Mar 20, Informational Health Canada begins release of clinical data. Mar 19, Mar 5, Feb 19, Ways to attract clients - Flyer distribution in Toronto, Canada. Feb 6, Dec 21, Dec 18, Dec 10, Dec 3, Canada - Registrars that allow e-auditing for ISO ? Nov 26, Nov 5, Oct 17, Oct 11, Oct 1, Selling Medical Devices in Canada - Distributor? Sep 14, Sep 11, Sep 5, Aug 28, May 8, Apr 24, Health Canada to increase PMS requirements.

Apr 18, Apr 6, Feb 13, Dec 8, Canada classification of surgical displays, MDL needed? Nov 23, Nov 21, What steps do you take to terminate a product which was licensed for sale in Canada. Oct 30, Health Canada email re fee proposals sent to group - driving me mad! Oct 25, Top Bottom. Canada Medical Device Regulations. Other Medical Device Related Standards. Service Industry Specific Topics.

Registrars and Notified Bodies.

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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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List of Acts and Regulations

Return to footnote a S. 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.

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