CMDR-加拿大醫(yī)療器械注冊(cè)

1、CMDRMedical Devices RegulationsSOR/98-282Registration 7 May, 1998FOOD AND DRUGS ACTMedical Devices RegulationsP.C. 1998-783 7 May, 1998His 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

2、 Act, here by makes the annexed Medical Devices Regulations.a S.C. 1993, c. 34, s. 73MEDICAL DEVICES REGULATIONSINTERPRETATION1. 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

3、source of energ y other than energy generated by the human body or gravity. A medical device that trans mits 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

4、 active device that, whether used alone or in combinat ion with another medical device, is intended to supply information for the purpose of dete cting, monitoring or treating a physiological condition, state of health, illness or congenit al deformity. (instrument diagnostique actif)active therapeu

5、tic device means an active device that, whether used alone or in combina tion with another medical device, is intended to support, modify, replace or restore a biol ogical function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. (inst

6、rument th rapeutique 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 Arti cle Number (EAN), assigned to a medical device by the manufacturer. (codebarres)body orifice means a natu

7、ral 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, bra chiocephalic artery, aorta,

8、 inferior and superior vena cava, renal arteries, iliac arteries and femoral arteries. (syst me car diovasculaire central)central nervous system means the brain, meninges, spinal cord and cerebrospinal fluid.( syst me nerveux central)meeclosed-loop system, in respect of a medical device, means a sys

9、tem that enables the dev ice to sense, interpret and treat a medical condition without human intervention. (syst a boucle ferme)econtrol 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

10、 hist ory of the manufacture, packaging, labelling and distribution of a unit, lot or batch of the device can be determined. (num ro decontr? le)custom-made device means a medical device, other than a mass-produced medical devic e, that(a) is manufactured in accordance with a health care professiona

11、ls written direction givin g 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 hi

12、s or her pr actice. (instrument fait sur mesure)dental material means a medical device that is intended to be inserted into the pulp cavi ty of a tooth or attached only to the enamel or dentin of a tooth. It does not include a surgi cal or dental instrument. (produit dentaire)directions for use, in

13、respect of a medical device, means full information as to the proce dures recommended for achieving the optimum performance of the device, and includes c autions, warnings, contra-indications and possible adverse effects. (mode demploi)dispenser means a person who is a member of a professional gover

14、ning body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical de vice in accordance with a health care professionals written directions in order to meet the specific requirements of a patient. (pr parateur) egenetic testing means the analysis of DNA, RN

15、A or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or progno sis. (test g n etique)health care facility means a facility that provides diagnostic or therapeutic services to p atients. It includes a group of such facilities that re

16、port to one common management thathas responsibility for the activities carried out in those facilities. (tablissement de sant )e ehealth care professional means a person who is entitled under the laws of a province to provide health services in the province. (professionnel de la sant )eidentifier m

17、eans a unique series of letters or numbers or any combination of these or a b ar 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)invas

18、ive device means a medical device that is intended to come into contact with the s urface 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

19、for the examination of specimens taken from the body. (instrument diagnostique i n vitro ou IDIV)manufacturer means a person who sells a medical device under their own name, or unde r a trade-mark, design, trade name or other name or mark owned or controlled by the pers on, and who is responsible fo

20、r designing, manufacturing, assembling, processing, labellin g, packaging, refurbishing or modifying the device, or for assigning to it a purpose, wheth er 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 no

21、t include anydevice that is intended for use in relation to animals. (instrument mdical)emedical device family means a group of medical devices that are made by the same man ufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that ha

22、ve the same intended use. (famille dinstruments)medical device group means a medical device comprising a collection of medical device s, such as a procedure pack or tray, that is sold under a single name. (ensemble dinstrume nts)medical device group family means a collection of medical device groups

23、 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 densembles dinstruments)name of the device, in respect of a medical device, includes any informati

24、on necessary f or the user to identify the device and to distinguish it from similar devices. (nom de linstr ument)near patient in vitro diagnostic device or near patient IVDD means an in vitro diagnos tic device that is intended for use outside a laboratory, for testing at home or at the point of c

25、are, such as a pharmacy, a health care professionals office or the bedside. (instrument diagnostique clinique in vitro)objective evidence means information that can be proved true, based on facts obtained t hrough observation, measurement, testing or other means, as set out in the definition obj ect

26、ive evidence in section 2.19 of International Organization for Standardization standar d ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended fr om time to time. (preuve tangible)person includes a partnership and an association. (personne)qualified investigator means a pe

27、rson who is a member in good standing of a profession al association of persons entitled under the laws of a province to provide health care in th e province and who is designated, by the ethics committee of the health care facility at wh ich investigational testing is to be conducted, as the person

28、 to conduct the testing. (cherch eur comp tent)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 no tify its owners and users of its defectiveness or potential defectiven

29、ess, after becoming aw are 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. (rap

30、pel)safety and effectiveness requirements means the safety and effectiveness requirements s et out in sections 10 to 20. (exigences en mati re de s? ret set defficacit ) eserious deterioration in the state of health means a life-threatening disease, disorder or a bnormal physical state, the permanen

31、t impairment of a body function or permanent damag e to a body structure, or a condition that necessitates an unexpected medical or surgical in tervention to prevent such a disease, disorder or abnormal physical state or permanent im pairment or damage. (d t ri oration grave de l tat de sant ) esign

32、ificant change means a change that could reasonably be expected to affect the safet y 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

33、 or procedur es 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 operat ion and specifications of materials, energy source, software or accessories; and(d

34、) the intended use of the device, including any new or extended use, any addition or del etion of a contra-indication for the device and any change to the period used to establish i ts expiry date. (modification importante)surgical or dental instrument means a reusable medical device that is intende

35、d for surgi cal or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, pun cturing, dilating, retracting or clipping, without connection to an active device. (instrume nt chirurgical ou dentaire)surgically invasive device means an invasive device that is intended to enter

36、 the body th rough an artificially created opening that provides access to body structures and fluids. (i nstrument effractif chirurgical)system means a medical device comprising a number of components or parts intended t o be used together to fulfil some or all of the devices intended functions, an

37、d that is sold under a single name. (syst me) etest kit means an in vitro diagnostic device that consists of reagents or articles, or any c ombination of these, and that is intended to be used to conduct a specific test. (trousse de ssai)validation means confirmation by examination and the provision

38、 of objective evidence t hat the requirements for a specific intended use have been fulfilled, as set out in the defini tion validation in section 2.18 of International Organization for Standardization standar d ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended fr om t

39、ime to time. (validation)APPLICATION2. 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 impor tation for personal use.3. (1) These Regulations also apply to an in vitro diagn

40、ostic product that is a drug or that contains a drug, as if the product were an in vitro diagnostic device.(2) Subsection does not apply to a drug listed in Schedule E or F to the Act, in the sch edule to Part G or J of the Food and Drug Regulations, in the Schedules to the Controlled Drugs and Subs

41、tances 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 sit e at a health care facility and permanently built into the structure o

42、f 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 Natio

43、nal Standard of Canada CAN/CSA-Z305.4, Qualification Requirements for Agencies Testing Nonflammable Medical Gas Piping Systems, as amen ded from time to time.CLASSIFICATION OF MEDICAL DEVICES6. Medical devices are classified into one of Classes I to IV by means of the classification rules set out in

44、 Schedule 1, where Class I represents the lowest risk and Class IV represe nts the highest risk.7. If a medical device can be classified into more than one class, the class representing th e higher risk applies.PART 1GENERALApplication8. This Part applies to medical devices that are not subject to P

45、art 2 or 3.Manufacturers Obligations9. (1) A manufacturer shall ensure that the medical device meets the safety and effectiven ess requirements.10. A manufacturer shall keep objective evidence to establish that the medical device mee ts those requirements.Safety and Effectiveness Requirements10. A m

46、edical device shall be designed and manufactured to be safe, and to this end the m anufacturer 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

47、to the extent possible,(ii) provide for protection appropriate to those risks, including the provision of alarms, an d(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 devi ce.11.

48、A medical device shall not, when used for the medical conditions, purposes or uses fo r which it is manufactured, sold or represented, adversely affect the health or safety of a p atient, user or other person, except to the extent that a possible adverse effect of the devic e constitutes an acceptab

49、le risk when weighed against the benefits to the patient and the ri sk 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 manufactur

50、ed, sold or repres ented.13. During the projected useful life of a medical device, its characteristics and performan ce shall not deteriorate under normal use to such a degree that the health or safety of a pat ient, user or other person is adversely affected.14. The characteristics and performance

51、of a medical device shall not be adversely affecte d by transport or conditions of storage, taking into account the manufacturers instructions and information for transport and storage.15. Reasonable measures shall be taken to ensure that every material used in the manufact ure of a medical device s

52、hall be compatible with every other material with which it intera cts 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 pa

53、tient, 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 devi

54、ce that is to be sold in a sterile condition shall be manufactured and ste rilized under appropriately controlled conditions, and the sterilization method used shall b e validated.18. A medical device that is part of a system shall be compatible with every other compon ent or part of the system with

55、 which it interacts and shall not adversely affect the perform ance of that system.19. A medical device that performs a measuring function shall be designed to perform tha t function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is ma

56、nufactured, 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 val idated.Labelling Requirements21. (1) No person shall import or sell a medical device u

57、nless the device has a label that s ets 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 o f a system, test kit, medical device group, medical device fam

58、ily 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, ex pressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;(f) the words Sterile and St rile, 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 manufactu rer on the basis of the component that has the shor