Medical Devices Regulations — 1
agnostique clinique in vitro ) objective evidence means information that can be proved true, based on facts obtained through observation, measurement, testing or other means, as set out in the definition objective evidence in section 2.19 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary , as amended from time to time. ( preuve tangible ) person includes a partnership and an association. ( personne ) qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care in the province and who is designated, by the ethics committee of the health care facility at which investigational testing is to be conducted, as the person to conduct the testing. ( chercheur compétent ) quality management system certificate means a valid quality management system certificate described in paragraph 32(2)(f), 3(j) or (4)(p), as applicable, that is issued by a registrar recognized by the Minister under section 32.1. ( certificat de système de gestion de la qualité ) quality system certificate [Repealed, SOR/2006-197, s. 1] recall means (a) a recall ordered by the Minister under section 21.3 of the Act; or (b) any action taken by a manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device (i) may present a risk of injury to health, (ii) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety, or (iii) may not meet the requirements of the Act or these Regulations. ( rappel ) regulatory agency means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. ( organisme de réglementation ) safety and effectiveness requirements [Repealed, SOR/2015-193, s. 1] serious deterioration in the state of health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. ( détérioration grave de l’état de santé ) shortage , in respect of a medical device, means a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada. ( pénurie ) significant change means a change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following: (a) the manufacturing process, facility or equipment; (b) the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture; (c) the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories; and (d) the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date. ( modification importante ) surgical or dental instrument means a reusable medical device that is intended for surgical or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting or clipping, without connection to an active device. ( instrument chirurgical ou dentaire ) surgically i