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Health Canada

　　Medical Devices Regulations

　　SOR/98-282

　　Registration 7 May, 1998

　　FOOD AND DRUGS ACT

　　Medical Devices Regulations

　　P.C. 1998-783 7 May, 1998

　　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 S.C. 1993, c. 34, s. 73

　　MEDICAL DEVICES REGULATIONS

　　INTERPRETATION

　　1. The definitions in this section apply in these Regulations.

　　"Act" means the Food and Drugs Act. (Loi)

　　"active device" means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. 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. (instrument actif)

　　"active diagnostic device" means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. (instrument diagnostique actif)

　　"active therapeutic device" means an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. (instrument thérapeutique actif)

　　"bar code" means a unique bar code in the symbology of the Universal Product Code (UPC), the Health Industry Business Communications Council (HIBCC) or the European Article Number (EAN), assigned to a medical device by the manufacturer. (code à barres)

　　"body orifice" means a natural opening or a permanent artificial opening in the body, such as a stoma. (orifice du corps)

　　"central cardiovascular system" means the heart, pericardium, pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, common carotid arteries, cerebral arteries, brachiocephalic artery, aorta, inferior and superior vena cava, renal arteries, iliac arteries and femoral arteries. (système cardiovasculaire central)

　　"central nervous system" means the brain, meninges, spinal cord and cerebrospinal fluid. (système nerveux central)

　　"closed-loop system", in respect of a medical device, means a system that enables the device to sense, interpret and treat a medical condition without human intervention. (système à boucle fermée)

　　"control number" means a unique series of letters, numbers or symbols, or any combination of these, that is assigned to a medical device by the manufacturer and from which a history of the manufacture, packaging, labelling and distribution of a unit, lot or batch of the device can be determined. (numéro de contr?le)

　　"custom-made device" means a medical device, other than a mass-produced medical device, that

　　(a) is manufactured in accordance with a health care professional's written direction giving its design characteristics;

　　(b) differs from medical devices generally available for sale or from a dispenser; and

　　(c) is

　　(i) for the sole use of a particular patient of that professional, or

　　(ii) for use by that professional to meet special needs arising in the course of his or her practice. (instrument fait sur mesure)

　　"dental material" means a medical device that is intended to be inserted into the pulp cavity of a tooth or attached only to the enamel or dentin of a tooth. It does not include a surgical or dental instrument. (produit dentaire)

　　"directions for use", in respect of a medical device, means full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contra-indications and possible adverse effects. (mode d'emploi)

　　"dispenser" means a person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional's written directions in order to meet the specific requirements of a patient. (préparateur)

　　"genetic testing" means the analysis of DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis. (test génétique)

　　"health care facility" means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)

　　"health care professional" means a person who is entitled under the laws of a province to provide health services in the province. (professionnel de la santé)

　　"identifier" means a unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. (identificateur)

　　"implant" means a medical device that is listed in Schedule 2. (implant)

　　"invasive device" means a medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. (instrument effractif)

　　"in vitro diagnostic device" or "IVDD" means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. (instrument diagnostique in vitro ou IDIV)

　　"manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. (fabricant)

　　"medical device" means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. (instrument médical)

　　"medical device family" means a group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. (famille d'instruments)

　　"medical device group" means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. (ensemble d'instruments)

　　"medical device group family" means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. (famille d'ensembles d'instruments)

　　"name of the device", in respect of a medical device, includes any information necessary for the user to identify the device and to distinguish it from similar devices. (nom de l'instrument)

　　"near patient in vitro diagnostic device" or "near patient IVDD" means an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional's office or the bedside. (instrument diagnostique 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)

　　"recall", in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device 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

　　(a) may be hazardous to health;

　　(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or

　　(c) may not meet the requirements of the Act or these Regulations. (rappel)

　　"safety and effectiveness requirements" means the safety and effectiveness requirements set out in sections 10 to 20. (exigences en matière de s?reté et d'efficacité)

　　"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)

　　"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 invasive device" means an invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids. (instrument effractif chirurgical)

　　"system" means a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device's intended functions, and that is sold under a single name. (système)

　　"test kit" means an in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test. (trousse d'essai)

　　"validation" means confirmation by examination and the provision of objective evidence that the requirements for a specific intended use have been fulfilled, as set out in the definition "validation" in section 2.18 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended from time to time. (validation)

　　APPLICATION

　　2. These Regulations apply to

　　(a) the sale and advertising for sale of a medical device; and

　　(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use.

　　3. (1) These Regulations also apply to an in vitro diagnostic product that is a drug or that contains a drug, as if the product were an in vitro diagnostic device.

　　(2) Subsection (1) does not apply to a drug listed in Schedule E or F to the Act, in the schedule to Part G or J of the Food and Drug Regulations, in the Schedules to the Controlled Drugs and Substances Act, or in the schedule to the Narcotic Control Regulations.

　　4. Only sections 26 to 31, 37, 70, 75, 80, 86 and 87 apply to a dispenser.

　　5. These Regulations do not apply to a medical gas piping system that is assembled on site at a health care facility and permanently built into the structure of the facility, if

　　(a) the system meets the requirements of National Standard of Canada CAN/CSA-Z305.1, Nonflammable Medical Gas Piping Systems, as amended from time to time; and

　　(b) a certificate of compliance with that standard has been issued by a testing agency that meets the requirements of National Standard of Canada CAN/CSA-Z305.4, Qualification Requirements for Agencies Testing Nonflammable Medical Gas Piping Systems, as amended from time to time.

　　CLASSIFICATION OF MEDICAL DEVICES

　　6. Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.

　　7. If a medical device can be classified into more than one class, the class representing the higher risk applies.

　　PART 1

　　GENERAL

　　Application

　　8. This Part applies to medical devices that are not subject to Part 2 or 3.

　　Manufacturer's Obligations

　　9. (1) A manufacturer shall ensure that the medical device meets the safety and effectiveness requirements.

　　(2) A manufacturer shall keep objective evidence to establish that the medical device meets those requirements.

　　Safety and Effectiveness Requirements

　　10. A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to

　　(a) identify the risks inherent in the device;

　　(b) if the risks can be eliminated, eliminate them;

　　(c) if the risks cannot be eliminated,

　　(i) reduce the risks to the extent possible,

　　(ii) provide for protection appropriate to those risks, including the provision of alarms, and

　　(iii) provide, with the device, information relative to the risks that remain; and

　　(d) minimize the hazard from potential failures during the projected useful life of the device.

　　11. A medical device shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.

　　12. A medical device shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.

　　13. During the projected useful life of a medical device, its characteristics and performance shall not deteriorate under normal use to such a degree that the health or safety of a patient, user or other person is adversely affected.

　　14. The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage, taking into account the manufacturer's instructions and information for transport and storage.

　　15. Reasonable measures shall be taken to ensure that every material used in the manufacture of a medical device shall be compatible with every other material with which it interacts and with material that may come into contact with it in normal use, and shall not pose any undue risk to a patient, user or other person.

　　16. The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including

　　(a) flammability or explosion;

　　(b) presence of a contaminant or chemical or microbial residue;

　　(c) radiation;

　　(d) electrical, mechanical or thermal hazards; and

　　(e) fluid leaking from or entering into the device.

　　17. A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated.

　　18. A medical device that is part of a system shall be compatible with every other component or part of the system with which it interacts and shall not adversely affect the performance of that system.

　　19. A medical device that performs a measuring function shall be designed to perform that function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is manufactured, sold or represented.

　　20. If a medical device consists of or contains software, the software shall be designed to perform as intended by the manufacturer, and the performance of the software shall be validated.

　　Labelling Requirements

　　21. (1) No person shall import or sell a medical device unless the device has a label that sets out the following information:

　　(a) the name of the device;

　　(b) the name and address of the manufacturer;

　　(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(d) in the case of a Class III or IV device, the control number;

　　(e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;

　　(f) the words "Sterile" and "Stérile", if the manufacturer intends the device to be sold in a sterile condition;

　　(g) the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;

　　(h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including the performance specifications of the device if those specifications are necessary for proper use;

　　(i) the directions for use, unless directions are not required for the device to be used safely and effectively; and

　　(j) any special storage conditions applicable to the device.

　　(2) The information required pursuant to subsection (1) shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.

　　22. (1) Subject to subsection (2), if a medical device is intended to be sold to the general public, the information required by subsection 21(1) shall

　　(a) be set out on the outside of the package that contains the device; and

　　(b) be visible under normal conditions of sale.

　　(2) Where a package that contains a medical device is too small to display all the information in accordance with section 21, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sale.

　　23. (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French.

　　(2) Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser.

　　(3) The directions for use in respect of a medical device that is sold at a self-service display shall, as a minimum, be in both English and French.

　　Contraceptive Devices -- Advertising

　　24. For the purposes of subsection 3(3) of the Act and subject to section 27, the following may be advertised to the general public by any means other than by the distribution of samples door to door or through the mail:

　　(a) subject to paragraph (b), a contraceptive device other than an intrauterine device; and

　　(b) a condom, provided its label claims only that the condom reduces the risk of transmitting venereal disease.

　　Class I Medical Devices

　　25. (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister's attention, that a Class I medical device may not meet the safety and effectiveness requirements, the Minister may request the manufacturer to submit, on or before a specified day, information to enable him or her to determine whether the device meets those requirements.

　　(2) The Minister may direct the manufacturer to stop the sale of a Class I medical device if

　　(a) the manufacturer does not comply with a request made pursuant to subsection (1) by the day specified in the request; or

　　(b) the Minister determines, on the basis of the information submitted pursuant to subsection (1), that the device does not meet the safety and effectiveness requirements.

　　(3) The Minister may lift the direction to stop the sale if

　　(a) the manufacturer provides the information requested;

　　(b) corrective action has been taken to ensure that the medical device satisfies the safety and effectiveness requirements; or

　　(c) the Minister's determination was unfounded.

　　Class II, III and IV Medical Devices

　　Prohibition

　　26. Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence.

　　27. No person shall advertise a Class II, III or IV medical device for the purpose of sale unless

　　(a) the manufacturer of the device holds a licence in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device licence; or

　　(b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law.

　　Medical Devices Deemed Licensed

　　28. If a system is licensed, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

　　29. If a test kit is licensed, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

　　30. If a medical device or a medical device group is licensed and forms part of a medical device family or a medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to have been licensed.

　　31. (1) If all the medical devices that form part of a medical device group are licensed, that medical device group is deemed to have been licensed.

　　(2) If a medical device group is licensed, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

　　Application for a Medical Device Licence

　　32. (1) An application for a medical device licence shall be submitted to the Minister by the manufacturer of the medical device in a format established by the Minister and shall contain the following:

　　(a) the name of the device;

　　(b) the class of the device;

　　(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(d) the name and address of the manufacturer as it appears on the device label; and

　　(e) the name and address of the establishment where the device is being manufactured, if different from the one referred to in paragraph (d).

　　(2) An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

　　(a) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;

　　(b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;

　　(c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;

　　(d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;

　　(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and

　　(f) an attestation by a senior official of the manufacturer, based on an audit by an organization that performs quality system audits, that the quality system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13488-98, Quality Systems -- Medical devices -- Particular requirements for the application of ISO 9002, as amended from time to time.

　　(3) An application for a Class III medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

　　(a) a description of the device and of the materials used in its manufacture and packaging;

　　(b) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;

　　(c) a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;

　　(d) a list of the standards complied with in the design and manufacture of the device to satisfy the safety and effectiveness requirements;

　　(e) in the case of a device to be sold in a sterile condition, a description of the sterilization method used;

　　(f) a summary of all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness requirements, and the conclusions drawn from those studies by the manufacturer;

　　(g) a copy of the device label;

　　(h) in the case of a near patient in vitro diagnostic device, a summary of investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;

　　(i) a bibliography of all published reports dealing with the use, safety and effectiveness of the device; and

　　(j) an attestation by a senior official of the manufacturer, based on an audit by an organization that performs quality system audits, that the quality system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001, as amended from time to time.

　　(4) An application for a Class IV medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

　　(a) a description of the device and of the materials used in its manufacture and packaging;

　　(b) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;

　　(c) a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;

　　(d) a risk assessment comprising an analysis and evaluation of the risks, and the risk reduction measures adopted to satisfy the safety and effectiveness requirements;

　　(e) a quality plan setting out the specific quality practices, resources and sequence of activities relevant to the device;

　　(f) the specifications of the materials used in the manufacture and packaging of the device;

　　(g) the manufacturing process of the device;

　　(h) a list of the standards complied with in the design and manufacture of the device to satisfy the safety and effectiveness requirements;

　　(i) detailed information on all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness requirements, including

　　(i) pre-/html/list_1677.html and /html/list_1677.html studies,

　　(ii) process validation studies,

　　(iii) if appropriate, software validation studies, and

　　(iv) literature studies;

　　(j) in the case of a medical device other than an in vitro diagnostic device, manufactured from or incorporating animal or human tissue or their derivative, objective evidence of the biological safety of the device;

　　(k) in the case of a near patient in vitro diagnostic device, detailed information on investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;

　　(l) a summary of the studies referred to in paragraph (i) and the conclusions drawn from those studies by the manufacturer;

　　(m) a summary of the investigational testing referred to in paragraph (k) and the conclusions drawn from that testing by the manufacturer;

　　(n) a bibliography of all published reports dealing with the use, safety and effectiveness of the device;

　　(o) a copy of the device label; and

　　(p) an attestation by a senior official of the manufacturer, based on an audit by an organization that performs quality system audits, that the quality system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001, as amended from time to time.

　　Foreign Manufacturers

　　33. (1) If an application for a medical device licence is submitted by a manufacturer of a country other than Canada, the information and documents described in subsections 32(2) to (4) need not be submitted if

　　(a) the applicant is governed, in that country, by a regulatory authority that is recognized by the Minister; and

　　(b) the application is accompanied by a certificate of compliance and a supporting summary report, issued by a conformity assessment body of that country that is recognized by the Minister, which certify that the medical device meets the safety and effectiveness requirements.

　　(2) For the purposes of subsection (1), the Minister may recognize a regulatory authority and a conformity assessment body of a country other than Canada only if it has the ability to determine whether the device meets the safety and effectiveness requirements.

　　(3) The Minister shall, on request, make available to any interested persons the list of recognized regulatory authorities and conformity assessment bodies of countries other than Canada.

　　Application for a Medical Device Licence Amendment

　　34. If the manufacturer proposes to make one or more of the following changes, the manufacturer shall submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change:

　　(a) in the case of a Class III or IV medical device, a significant change;

　　(b) a change that would affect the class of the device;

　　(c) a change in the name of the manufacturer;

　　(d) a change in the name of the device;

　　(e) a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(f) in the case of a Class II medical device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

　　Additional Information and Samples

　　35. (1) If the information and documents submitted in respect of an application for a medical device licence or a medical device licence amendment are insufficient to enable the Minister to determine whether a medical device meets the safety and effectiveness requirements, the Minister may request the manufacturer to submit, on or before a specified day, additional information necessary for making the determination.

　　(2) In the course of examining the application, the Minister may require the applicant to provide samples of the medical device.

　　Issuance

　　36. (1) If the Minister determines that a medical device in respect of which an application is submitted meets the safety and effectiveness requirements, the Minister shall

　　(a) issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or

　　(b) amend the medical device licence, in the case of an application for a medical device licence amendment.

　　(2) The Minister may set out in a medical device licence terms and conditions respecting

　　(a) the tests to be performed on a device to ensure that it continues to meet the safety and effectiveness requirements; and

　　(b) the requirement to submit the results and protocols of any tests performed.

　　(3) The Minister may amend the terms and conditions of the medical device licence to take into account any new development with respect to the device.

　　(4) The holder of the medical device licence shall comply with the terms and conditions of the licence.

　　Lot of In Vitro Diagnostic Devices

　　37. No person shall sell a medical device from a lot of licensed in vitro diagnostic devices in respect of which terms and conditions were set out in the licence pursuant to section 36, unless

　　(a) the results and protocol of any test performed on the device in accordance with those terms and conditions have been provided to the Minister; and

　　(b) the Minister determines, on the basis of the information received under paragraph (a), that the device continues to meet the safety and effectiveness requirements.

　　Refusal to Issue

　　38. (1) The Minister may refuse to issue or amend a medical device licence if

　　(a) the applicant does not comply with these Regulations or any provisions of the Act relating to medical devices;

　　b) the applicant has made a false or misleading statement in the application;

　　(c) the medical device does not comply with the labelling requirements set out in sections 21 to 23; or

　　(d) the applicant has not complied with a request for additional information or samples made pursuant to section 35 by the day specified in the request.

　　(2) The Minister shall refuse to issue or amend a medical device licence if the medical device does not meet the safety and effectiveness requirements or if the information or samples provided pursuant to section 35 are insufficient to enable the Minister to determine whether the medical device meets those requirements.

　　(3) If the Minister refuses to issue or amend a medical device licence, the Minister shall

　　(a) notify the applicant in writing of the reasons for the refusal; and

　　(b) give the applicant an opportunity to be heard.

　　Additional Information

　　39. If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister's attention, that a licensed medical device may not meet the safety and effectiveness requirements, the Minister may request the manufacturer to submit, on or before a specified day, information or samples to enable the Minister to determine whether the device meets those requirements.

　　Suspension

　　40. (1) Subject to subsection (3), the Minister may suspend a medical device licence if the Minister has reasonable grounds to believe that

　　(a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

　　(b) the licensee has made a false or misleading statement in the application;

　　(c) the licensee has failed to comply with the terms and conditions of the licence;

　　(d) the licensee has not complied with a request for information or samples made pursuant to section 39 by the day specified in the request, or the information or samples provided are insufficient to enable the Minister to determine whether the medical device meets the safety and effectiveness requirements;

　　(e) the medical device no longer meets the safety and effectiveness requirements; or

　　(f) on the basis of information obtained after the device was licensed, the quality system under which the device has been designed, in the case of a Class III or IV device, or manufactured, assembled, processed, packaged, refurbished or modified, in the case of a Class II, III or IV device, is inadequate to ensure that the device meets its specifications.

　　(2) Before suspending a medical device licence, the Minister shall consider

　　(a) the licensee's history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

　　(b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

　　(3) Subject to section 41, the Minister shall not suspend a medical device licence until

　　(a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

　　(b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

　　(c) the licensee has been given an opportunity to be heard in respect of the suspension.

　　41. (1) The Minister may suspend a medical device licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

　　(2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

　　(3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.

　　42. The Minister may reinstate a medical device licence if the situation giving rise to the suspension has been corrected or if the reason for the suspension was unfounded.

　　Obligation to Inform

　　43. (1) Every manufacturer of a licensed medical device shall, annually before November 1 and in a form authorized by the Minister, furnish the Minister with a statement signed by the manufacturer or by a person authorized to sign on the manufacturer's behalf

　　(a) confirming that all the information and documents supplied by the manufacturer with respect to the device are still correct; or

　　(b) describing any change to the information and documents supplied by the manufacturer with respect to the device, other than those to be submitted pursuant to section 34.

　　(2) If the manufacturer fails to comply with subsection (1), the Minister may cancel the medical device licence.

　　(3) If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuance, and the licence shall be cancelled at the time that the Minister is informed.

　　Establishment Licence

　　Prohibition

　　44. (1) No person shall import or sell a medical device unless the person holds an establishment licence.

　　(2) Subsection (1) does not apply to the importation or sale of a medical device by

　　(a) a retailer;

　　(b) a health care facility;

　　(c) in the case of a Class II, III or IV medical device, the manufacturer of the medical device; or

　　(d) in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an establishment licence.

　　Application

　　45. An application for an establishment licence shall be submitted to the Minister in a format established by the Minister and shall contain the following:

　　(a) the name and address of the establishment;

　　(b) the name, title and telephone number of the representative of the establishment to contact for any information concerning the application;

　　(c) a statement as to whether the activity of the establishment is importation or distribution, or both;

　　(d) the names and addresses of the manufacturers of the devices that are being imported or distributed;

　　(e) for each manufacturer, the medical specialities, selected from among the specialities established by the Minister, in respect of which the devices are imported or distributed;

　　(f) for each manufacturer, the classes of the devices that are being imported or distributed;

　　(g) an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of distribution records, complaint handling and recalls;

　　(h) if the establishment imports devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of mandatory problem reporting;

　　(i) if the establishment imports or distributes Class II, III or IV devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place, where applicable, for handling, storage, delivery, installation, corrective action and servicing in respect of those devices; and

　　(j) the address of each building in Canada where the procedures described in paragraphs (g) to (i) are in place.

　　Issuance

　　46. (1) If the Minister determines that the application for an establishment licence meets the requirements of section 45, the Minister shall issue to the applicant a licence in respect of the establishment.

　　(2) An establishment licence shall expire on December 31 of each year.

　　Refusal

　　47. (1) The Minister may refuse to issue an establishment licence if the applicant has made a false or misleading statement in the application.

　　(2) The Minister shall refuse to issue an establishment licence if the Minister has reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons.

　　(3) If the Minister refuses to issue an establishment licence, the Minister shall

　　(a) notify the applicant in writing of the reasons for the refusal; and

　　(b) give the applicant an opportunity to be heard.

　　Notification

　　48. If, following the issuance of an establishment licence, there is a change to any of the information submitted in accordance with paragraph 45(a) or (b), the holder of the establishment licence shall submit the new information to the Minister within 15 days of the change.

　　Suspension

　　49. (1) Subject to subsection (3), the Minister may suspend an establishment licence if the Minister has reasonable grounds to believe that

　　(a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

　　(b) the licensee has made a false or misleading statement in the application; or

　　(c) failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.

　　(2) Before suspending an establishment licence, the Minister shall consider

　　(a) the licensee's history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

　　(b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

　　(3) Subject to section 50, the Minister shall not suspend an establishment licence until

　　(a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

　　(b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

　　(c) the licensee has been given ,, an , , , , , , , , , opportunity to be heard in respect of the suspension.

　　50. (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

　　(2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

　　(3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.

　　51. The Minister may reinstate an establishment licence if the situation giving rise to the suspension has been corrected or if the reason for the suspension was unfounded.

　　Distribution Records

　　52. (1) The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device.

　　(2) Subsection (1) does not apply to

　　(a) a retailer; or

　　(b) a health care facility in respect of a medical device that is distributed for use within that facility.

　　53. The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market.

　　54. (1) The distribution record maintained by a manufacturer of an implant shall also contain a record of the information received on the implant registration cards forwarded to the manufacturer from a health care facility pursuant to section 67.

　　(2) The manufacturer of an implant shall update the information referred to in subsection (1) in accordance with any information received from the health care facility or the patient.

　　55. The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of

　　(a) the projected useful life of the device, and

　　(b) two years after the date the device is shipped.

　　56. Distribution records shall be maintained in a manner that will allow their timely retrieval.

　　Complaint Handling

　　57. (1) The manufacturer, importer and distributor of a medical device shall each maintain records of the following:

　　(a) reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and

　　(b) all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph (a).

　　(2) Subsection (1) does not apply to

　　(a) a retailer; or

　　(b) a health care facility in respect of a medical device that is distributed for use within that facility.

　　58. The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out

　　(a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and

　　(b) an effective and timely recall of the device.

　　Mandatory Problem Reporting

　　59. (1) Subject to subsection (2), the manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring inside or outside Canada and involving a device that is sold in Canada and that

　　(a) is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its the directions for use; and

　　(b) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur.

　　(2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer's intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.

　　60. (1) A preliminary report shall be submitted to the Minister

　　(a) in respect of an incident that occurs in Canada

　　(i) within 10 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, or

　　(ii) within 30 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were it to recur; and

　　(b) in respect of an incident that occurs outside Canada, as soon as possible after the manufacturer has indicated, to the regulatory agency referred to in paragraph 59(2), the manufacturer's intention to take corrective action, or after the regulatory agency has required the manufacturer to take corrective action.

　　(2) The preliminary report shall contain the following information:

　　(a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(b) if the report is made by

　　(i) the manufacturer, the name and address of that manufacturer and of any known importer, and the name, title and telephone and facsimile numbers of a representative of the manufacturer to contact for any information concerning the incident, or

　　(ii) the importer of the device, the name and address of the importer and of the manufacturer, and the name, title and telephone and facsimile numbers of a representative of the importer to contact for any information concerning the incident;

　　(c) the date on which the incident came to the attention of the manufacturer or importer;

　　(d) the details known in respect of the incident, including the date on which the incident occurred and the consequences for the patient, user or other person;

　　(e) the name, address and telephone number, if known, of the person who reported the incident to the manufacturer or importer;

　　(f) the identity of any other medical devices or accessories involved in the incident, if known;

　　(g) the manufacturer's or importer's preliminary comments with respect to the incident;

　　(h) the course of action, including an investigation, that the manufacturer or importer proposes to follow in respect of the incident and a timetable for carrying out any proposed action and for submitting a final report; and

　　(i) a statement indicating whether a previous report has been made to the Minister with respect to the device and, if so, the date of the report.

　　61. After making a preliminary report in accordance with section 60, the manufacturer and the importer of a medical device involved in an incident shall each, within the time established pursuant to paragraph 60(2)(h), submit to the Minister a final report containing the following information:

　　(a) a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died;

　　(b) a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident; and

　　(c) any actions taken as a result of the investigation, which may include

　　(i) increased post-market surveillance of the device,

　　(ii) corrective and preventive action respecting the design and manufacture of the device, and

　　(iii) recall of the device.

　　62. In addition to making preliminary and final reports concerning an incident, the manufacturer and the importer of a medical device shall, at the Minister's request and within 30 days of the request, make a summary report to the Minister concerning any incident that was the subject of such reports and that occurred during the 12 months preceding the request or during a period specified by the Minister.

　　Recall

　　63. Sections 64 and 65 do not apply to

　　(a) a retailer; or

　　(b) a health care facility in respect of a medical device that is distributed for use within that facility.

　　64. The manufacturer and the importer of a medical device shall, on or before undertaking a recall of the device, each provide the Minister with the following:

　　(a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(b) the name and address of the manufacturer and importer, and the name and address of the establishment where the device was manufactured, if different from that of the manufacturer;

　　(c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered;

　　(d) an evaluation of the risk associated with the defectiveness or possible defectiveness;

　　(e) the number of affected units of the device that the manufacturer or importer

　　(i) manufactured in Canada,

　　(ii) imported into Canada, and

　　(iii) sold in Canada;

　　(f) the period during which the affected units of the device were distributed in Canada by the manufacturer or importer;

　　(g) the name of each person to whom the affected device was sold by the manufacturer or importer and the number of units of the device sold to each person;

　　(h) a copy of any communication issued with respect to the recall;

　　(i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion;

　　(j) the proposed action to prevent a recurrence of the problem; and

　　(k) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the recall.

　　65. The manufacturer and the importer of a medical device shall, as soon as possible after the completion of a recall, each report to the Minister

　　(a) the results of the recall; and

　　(b) the action taken to prevent a recurrence of the problem.

　　Implant Registration

　　66. (1) Subject to section 68, the manufacturer of an implant shall provide, with the implant, two implant registration cards that contain

　　(a) the name and address of the manufacturer;

　　(b) the name and address of any person designated by the manufacturer for the collection of implant registration information;

　　(c) a notice advising the patient that the purpose of the cards is to enable the manufacturer to notify the patient of new information concerning the safety, effectiveness or performance of the implant, and any required corrective action; and

　　(d) a statement advising the patient to notify the manufacturer of any change of address.

　　(2) An implant registration card shall be designed for the recording of the following information:

　　(a) the name of the device, its control number and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

　　(b) the name and address of the health care professional who carried out the implant procedure;

　　(c) the date on which the device was implanted;

　　(d) the name and address of the health care facility at which the implant procedure took place; and

　　(e) the patient's name and address or the identification number used by the health care facility to identify the patient.

　　(3) The two implant registration cards referred to in subsection (1) shall be printed in both official languages; however, the manufacturer may choose to provide four cards, two in English and two in French.

　　67. (1) Subject to subsection (2), a member of the staff of the health care facility where an implant procedure takes place shall, as soon as possible after the completion of the procedure, enter the information required by subsection 66(2) on each implant registration card, give one card to the implant patient and forward one card to the manufacturer of the implant or the person designated pursuant to paragraph 66(1)(b).

　　(2) The patient's name and address shall not be entered on the implant registration card forwarded to the manufacturer or person designated pursuant to paragraph 66(1)(b) except with the patient's written consent.

　　(3) The health care facility, the manufacturer or the person designated pursuant to paragraph 66(1)(b) shall not disclose the patient's name or address, or any information that might identify the patient, unless the disclosure is required by law.

　　68. (1) The manufacturer of an implant may apply in writing to the Minister for authorization to use an implant registration method other than the implant registration cards described in section 66.

　　(2) The Minister shall authorize the use of the implant registration method proposed in the application referred to in subsection (1) if the Minister determines that the method will enable the manufacturer to achieve the purpose set out in paragraph 66(1)(c) as effectively as the use of implant registration cards.

　　(3) Where an authorization has been granted pursuant to subsection (2), the manufacturer shall implement the alternative implant registration method, and sections 66 and 67 shall apply with such modifications as are necessary.

　　PART 2

　　CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL ACCESS

　　Application

　　69. (1) This Part applies to custom-made devices and medical devices that are to be imported or sold for special access.

　　(2) In this Part, "special access" means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.

　　General

　　70. No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless t

　　(3) The health care facility, the manufacturer or the person designated pursuant to paragraph 66(1)(b) shall not disclose the patient's name or address, or any information that might identify the patient, unless the disclosure is required by law.

　　68. (1) The manufacturer of an implant may apply in writing to the Minister for authorization to use an implant registration method other than the implant registration cards described in section 66.

　　(2) The Minister shall authorize the use of the implant registration method proposed in the application referred to in subsection (1) if the Minister determines that the method will enable the manufacturer to achieve the purpose set out in paragraph 66(1)(c) as effectively as the use of implant registration cards.

　　(3) Where an authorization has been granted pursuant to subsection (2), the manufacturer shall implement the alternative implant registration method, and sections 66 and 67 shall apply with such modifications as are necessary.

　　PART 2

　　CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL ACCESS

　　Application

　　69. (1) This Part applies to custom-made devices and medical devices that are to be imported or sold for special access.

　　(2) In this Part, "special access" means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.

　　General

　　70. No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless t