Medical Devices Regulations

SOR/98-282

FOOD AND DRUGS ACT

CMDCAS加拿大医疗器械法规

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.

医疗器械分类

6．根据附表1中所规定的分类标准，医疗器械可划分为第一类至第四类。其中第一类器械代表具有最低级别危险度的器械，第四类代表具有最高危险度的器械。

7．如果某一医疗器械可划分到多于一个类别中，则该器械也可划分到代表最高级别危险度的类别中。

SCHEDULE 1 (Section 6)

CLASSIFICATION RULES FOR MEDICAL DEVICESPART 1

MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC DEVICES

Invasive DevicesRule 1:

(1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II.

(2) A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero is classified as Class IV.

(3) A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is classified as Class III.

Rule 2:

(1) Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.

(2) A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.

(3) A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III.

(4) A device described in subrule (1) that is intended to be represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof is classified as Class III.

Rule 3:

Despite rules 1 and 2

(a) all denture materials and orthodontic appliances, and their accessories, are classified as Class II;

(b) all surgical or dental instruments are classified as Class I; and

(c) all latex condoms are classified as Class II.

Non-invasive Devices

Rule 4:

(1) Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II.

(2) A device described in subrule (1) that is intended to be used as a mechanical barrier, for compression or for absorption of exudations, is classified as Class I.

Rule 5:

A non-invasive device intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class II.

Rule 6:

(1) Subject to subrules (2) and (3), a non-invasive device intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class III.

(2) A device described in subrule (1) whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance, is classified as Class IV.

(3) A device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II.

Rule 7:

(1) Subject to subrule (2), all other non-invasive devices are classified as Class I.

(2) A device described in subrule (1) is classified as Class II if it is intended

(a) to act as a calibrator, tester or quality control support to another medical device; or

(b) to be connected to an active device that is classified as Class II, III or IV.

附表1

（第6部分）医疗器械分类规则

第一部分除体外诊断设备外的医疗器械

侵入性设备

规则1：

（1）依照辅助规则（2）和（3），所有的外科侵入性设备被归为二类。

（2）有意用于诊断，监控，控制或纠正心脏血管或中枢神经系统或胎儿镜中的胎儿缺陷的外科侵入性设备被归为四类。

（3）用于为人体所吸收或要在人体中连续逗留至少30天的外科侵人性设备被归为三类。

规则2：

（1）依照辅助规则（2）到（4），所有通过人体体腔的出口或入口或接触眼睛表面侵人人体的侵入性设备被归为二类。

（2）在辅助规则（1）中描述的有意用于安置在口腔或鼻腔中的直通咽或在耳中通到鼓膜的设备被归为一类。

（3）在辅助规则（1）中描述的通常有意用于留在体内或接触眼睛表面至少连续 30天的设备被归为三类。

（4）在辅助规则(1）中描述的有意用于描述为防止在性活动中易感染物质的传播或减少在其中的风险的设备被归为三类。

规则3：

尽管有规则1 和2

（a）所有假牙材料和正牙用具和它们的附件，被归为二类；

(b）所有外科或牙科器械被归为一类；并且

（c）所有乳胶避孕套被归为二类。

非侵入性设备

规则4：

（1）依照辅助规则（2），所有有意用于接触受损皮肤的非侵人性设备被归为二类。

（2）在辅助规则（1）中描述的有意用于压缩或吸收渗出物的机械性障碍物，被归为一类。

规则5：

有意用于引导或储存气体，液体，人体组织或体液以达到通过灌输或其他给药方法导入人体的目的的非侵入性设备被归为二类。

规则6：

（1）依照辅助规则（2）和（3），有意用于修改血液或其他体液，或液体的生物或化学结构以达到通过灌输或其他给药方法导入人体的目的的非侵入性设备被归为三类。

（2）在辅助规则（1）中描述的那些特性是变型进程可能导致异物进入人体而具有潜在危险的设备，考虑到物质的特性和数量，被归为四类。

（3）在辅助规则（1）中描述的通过离心法，重力过滤法或气热交换法来完成变型的设备被归为二类。

规则7：

（1）依照辅助规则（2），所有其他的非侵入性设备被归为一类。

（2）在辅助规则（1）中描述的设备被归为二类的设备如有意被用于

（a）作口径测量器，试验装置或针对其他医疗器械的质量控制帮助；或

（b）被连接到被归为二类，三类或四类的有源设备

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.

许可证申请

45．营业许可证申请时应以卫生部规定的格式将申请文件提交卫生部审核批准，申请文件应包含以下内容：

（a）公司的名称和地址；

（b）公司负责许可证申请事宜联系人的姓名，职位和电话号码；

（c）说明公司的营销范围是从事进口还是销售，或者是兼有这两项业务；

（d）公司进日或销售医疗器械的生产厂商的名称和地址；

（e）根据卫生部制定的医疗专业类别，对进口或销售的医疗器械生产厂商进行分类；

（f）进口或销售的由生产厂商制造的医疗器械类别；

（g）公司高层应证明，该公司已经制定有执行销售记录，纠纷处理和产品收回的正式程序；

（h）对于医疗器械进口公司，公司高层应证明，该公司已经制定有强制性问题报告的正式程序；

（i）对于进口或销售第二类、第三类、或第四类医疗器械的公司，公司高层应证明，该公司已经针医疗器械操作，存储，交付，安装，调整和服务，制定有适用的正式程序：并且

（j）根据本规定(g）至(i）中的条款要求，提供公司在加拿大境内各处的地址。

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.

许可证吊销

49．（1）根据第（3）条规定，如果卫生部有正当理由相信存在以下情况，卫生部将吊销持有者的营业许可证。

（a）许可证持有人违反了这些规定或任何与医疗器械有关的法律条款；

（b）许可证持有者在申请文件中做出了虚假或易被人误解的说明；或是

（c）如不吊销营业许可证，将对病人，用户或其他人的健康或安全构成威胁。

（2）吊销营业许可证之前，卫生部应考虑以下事宜：

（a）许可证持有者对于这些规定和其他与医疗器械相关法律条款的遵守情况记录；并且

（b）如果让营业许可证继续保持有效，对病人、用户或其他人的健康或安全将会构成的威胁。

（3）根据第50条的规定，卫生部在吊销许可证之前应采取以下行动：

（a) 卫生部已经向许可证持有人发送了书面通知，说明吊销许可证的理由，应采取的改正措施，以及改正措施的的定期限；

（b）在被要求采取改正措施的情况下，在通知规定期限内没有采取措施；并且

（c) 许可证持有者已经被给予了一次吊销申诉机会。

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.

销售记录—

52．（1）医疗器械的生产商，进口商和销售商应针对各医疗器械保存销售记录。

（2）第（1）条不适用于以下范围：

（a）零售商；或

（b）只将医疗器械用于内部使用的卫生保健机构。