加拿大医疗器材登记法规问答集

加拿大主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支援的会计薪资服务。 加拿大多伦多与臺湾同事携手协同爲您服务。为地球暖化尽一份心力，减少空中旅行。
Email：yto4ww@evershinecpa.com
或
加拿大永辉BPO有限公司
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Manager Ian Lin 说中文和英文
或
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联络人：林幸穗 Anny Lin 协理
手机：+886-937-606-272
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电话：+886-2-2717-0515 分机:110

时间：2022/07/28 drafted by Yvonne Chen

各国医疗器材登记法规问答集

HLF-TW-10
请问加拿大对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in Canadas? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在加拿大，健康卫生部(HC)是医疗器材的主管部门，其中的医疗器材管理局 (MDD) 是监测和评估加拿大诊断和治疗医疗器材的安全性、有效性和品质的国家机构，MDD 确保在加拿大销售的医疗器材符合安全性、有效性和品质要求。

医疗器材是用于治疗、诊断或预防疾病或异常身体状况的任何仪器或材料，不包括用于动物或兽医目的之设备。分类规则分为 I 类至 IV 类之一，其中 I 类代表最低风险，IV 类代表最高风险。如果医疗器材可以分为多个类别，则适用代表较高风险的类别。依据风险大小，产品註册的要求也逐级增加，品质系统要求也是愈加详尽。

1.医疗器材包括一系列健康产品，包括：
．绷带/胶带（I 类）
．拐杖和手杖（I类）
．牙刷-手动（I 类）
．牙刷-电动（II 类）
．助听器（II类）
．髋关节植入物（III 类）
．呼吸器（III类）
．人造心脏（IV类）

2. 医疗器材分类规则
   ．Ⅰ类：最低风险器材，例如：伤口护理和非外科侵入器材。
   ．Ⅱ类：低风险器材，例如：隐形眼镜和大多数外科侵入器材；
   ．Ⅲ类：中等风险器材，例如：髋关节植入物，葡萄糖监测器和预期可被身体吸收或预期在身体中停留至少30个连续天的外科侵入器材。
   ．Ⅳ类：高风险器材，例如：心脏起搏器和用于诊断、控制心血管中枢系统的缺陷的外科侵入器材。
3. 医疗器材分为以下四组：
   ．侵入器材
   ．非侵入器材
   ．有源器材
   ．特殊规则

In Canada, the Ministry of Health (HC) is the competent authority for medical devices, and the Medical Devices Administration (MDD) is a national agency that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada. MDD ensures that in Medical devices sold in Canada meet safety, efficacy and quality requirements.

A medical device is any instrument or material used in the treatment, diagnosis or prevention of a disease or abnormal physical condition, excluding device for animal or veterinary purposes. The classification rules are divided into one of classes I to IV, where class I represents the lowest risk and class IV represents the highest risk. If a medical device can be classified into more than one category, the category representing the higher risk applies. According to the degree of risk, the requirements for product registration are also gradually increased, and the requirements for the quality system are also becoming more detailed.

1. Medical device includes a series of health products, including:
   ． Bandages/Tapes (Class I)
   ． Crutches and canes (Class I)
   ． Toothbrush – Manual (Class I)
   ． Toothbrush – Electric (Class II)
   ． Hearing aids (Class II)
   ． Hip Implants (Class III)
   ． Respirator (Class III)
   ． Artificial Heart (Class IV)
2. Medical device classification rules
   ． Class I: Minimal risk devices such as wound care and non-surgical invasive devices.
   ． Class II: Low-risk devices, such as contact lenses and most surgical invasive devices;
   ． Class III: Moderate risk devices such as hip implants, glucose monitors, and surgically invasive devices that are expected to be absorbed by the body or that are expected to remain in the body for at least 30 consecutive days.
   ． Class IV: High-risk devices, such as cardiac pacemakers and surgically invasive devices used to diagnose and control defects in the central cardiovascular system.
3. Medical devices are divided into the following four groups:
   ． Intrusion device
   ． Non-invasive device
   ． Active device
   ． Special rules

【参考连结】
https://www.canada.ca/en.html
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html

HLF-TW-20
外国公司要到加拿大销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in Canada, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，一般来说，在加拿大进口或销售医疗器材都需要取得医疗器材企业许可证(MDEL)。

1.网页：通过电子邮件提交申请。
mdel.application.leim@hc-sc.gc.ca
2.申请资料：
申请表 (FRM-0292)：
．机构名称：个人的法定名称。
．经营名称、贸易名称或合伙名称：申请人拥有的任何其他公司名称（与申请人相同的法律实体）（如适用）。
．小型企业：表明您是否是小型企业。如果您符合小型企业定义，可能有资格获得费用减免。
．政府组织：表明您是否是政府组织。加拿大政府或省或地区的任何分支机构或机构提交的所有申请均免缴费用。
．设立地址
．企业号码 ( BN )
．联繫人：卫生部会将年度许可证审查包发送给企业许可证联繫人。所需讯息是企业代表的姓名、职务和电话号码、电子邮件，以便联繫。
．邮寄地址、账单地址
．活动：选取适用于运营的每项活动和医疗设备类别。
．站点：每个活动阶段位置、地点。
．製造商或供应商讯息
．I 类医疗器材的进口商和/或分销商：请提供您将进口或分销的 I 类医疗器材的的名称和完整地址
．II、III 或 IV 类医疗器材的进口商和/或经销商：必须在医疗器材有效许可证列表( MDALL ) 数据库中搜索所有II、III 或IV 类医疗器材医疗器材许可证的製造商，确认製造商已获得您将进口和/或分销（销售）的所有类别设备的许可。
．证明：公司高级官员的证明文件，确认每份声明并签署。
．签名。
3.注意
．医疗器材企业许可证 (MDEL) 申请必须列出计划在加拿大进口或分销的每个製造商或供应商的医疗器材类别。
．作为加拿大医疗器材的进口商或经销商，如果不确定打算出售或进口到加拿大供人使用的医疗器材的分类，您有责任联繫製造商以获取更多讯息。
．如果医疗器材属于多个类别，则适用较高的风险类别。例如，当某医疗器材同时被分类为第三类和第四类时，该医疗器材的最终分类为第四类。

Yes. Generally, a Medical Device Establishment License (MDEL) is required by anyone who imports or sells a medical device in Canada.

1.Webpage: Submit the application by email.
mdel.application.leim@hc-sc.gc.ca
2.Application materials:
Application Form (FRM-0292):
．Organization Name: The legal name of the individual.
．Business Name, Trading Name, or Partnership Name: Any other business name (same legal entity as applicant) owned by the applicant, if applicable.
．Small Business: Indicate whether you are a small business. If you meet the small business definition, you may be eligible for a fee waiver.
．Government Organization: Indicate whether you are a government organization. All applications submitted by any branch or agency of the Government of Canada or a province or territory are exempt from payment of the fee.
．Set up address
．Business Number ( BN )
．Contact: The Department of Health will send an annual license review packet to the business license contact. The required information is the business representative’s name, title and phone number, e-mail, in order to contact.
．Mailing address, billing address
．Activities: Select each activity and medical device category as applicable to the operation.
．Site: the location and location of each activity stage.
．Manufacturer or Supplier Information
．Importers and/or Distributors of Class I Medical Devices: Please provide the name and complete address of the Class I medical device you will be importing or distributing
．Importers and/or Distributors of Class II, III, or IV Medical Devices: Must search the Medical Device Valid License List (MDALL) database for all manufacturers of Class II, III, or IV medical devices with a medical device license to confirm manufacture The dealer has been licensed for all classes of device that you will import and/or distribute (sell).
．Certification: Documentation from a senior company official confirming each statement and signing it.
．Sign.

3. Pay attention
   ．A Medical Device Establishment License (MDEL) application must list each manufacturer’s or supplier’s class of medical device that it plans to import or distribute in Canada.
   ．As an importer or distributor of medical devices in Canada, it is your responsibility to contact the manufacturer for more information if you are unsure of the classification of a medical device intended for sale or imported into Canada for human use.
   ．If a medical device falls into more than one category, the higher risk category applies. For example, when a medical device is classified into Class III and Class IV at the same time, the final classification of the medical device is Class IV.

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html#_Establishment_licence_exemptions
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

HLF-TW-25

HLF-TW-30
外国公司要到加拿大销售医疗器材，可以指派加拿大公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in Canadas, can it assign an Canadas company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?

Evershine RD：
可以，营业代理人需具备营业许可证，也就是医疗器材企业许可证(MDEL)。

1.网页：通过电子邮件提交申请。
mdel.application.leim@hc-sc.gc.ca
2.申请资料：
申请表 (FRM-0292)：
．机构名称：个人的法定名称。
．经营名称、贸易名称或合伙名称：申请人拥有的任何其他公司名称（与申请人相同的法律实体）（如适用）。
．小型企业：表明您是否是小型企业。如果您符合小型企业定义，可能有资格获得费用减免。
．政府组织：表明您是否是政府组织。加拿大政府或省或地区的任何分支机构或机构提交的所有申请均免缴费用。
．设立地址
．企业号码 ( BN )
．联繫人：卫生部会将年度许可证审查包发送给企业许可证联繫人。所需讯息是企业代表的姓名、职务和电话号码、电子邮件，以便联繫。
．邮寄地址、账单地址
．活动：选取适用于运营的每项活动和医疗设备类别。
．站点：每个活动阶段位置、地点。
．製造商或供应商讯息
．I 类医疗器材的进口商和/或分销商：请提供您将进口或分销的 I 类医疗器材的的名称和完整地址
．II、III 或 IV 类医疗器材的进口商和/或经销商：必须在医疗器材有效许可证列表( MDALL ) 数据库中搜索所有II、III 或IV 类医疗器材医疗器材许可证的製造商，确认製造商已获得您将进口和/或分销（销售）的所有类别设备的许可。
．证明：公司高级官员的证明文件，确认每份声明并签署。
．签名。
3.注意
．医疗器材企业许可证 (MDEL) 申请必须列出计划在加拿大进口或分销的每个製造商或供应商的医疗器材类别。
．作为加拿大医疗器材的进口商或经销商，如果不确定打算出售或进口到加拿大供人使用的医疗器材的分类，您有责任联繫製造商以获取更多讯息。
．如果医疗器材属于多个类别，则适用较高的风险类别。例如，当某医疗器材同时被分类为第三类和第四类时，该医疗器材的最终分类为第四类。

产品责任
医疗器材的製造商、进口商有责任对医疗器材负责，当发生安全事件、品质问题，製造商和进口商需向卫生部提交报告及採取因应措施。

1.初步报告
．器材名称及其标示，包括：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材。
．製造商、该製造商和任何已知进口商的名称和地址，以及製造商代表的姓名、职务、电话号码和传真号码，以便联繫以获取有关该事件的任何讯息。
．器材的进口商、进口商和製造商的名称和地址，以及进口商代表的姓名、职务、电话号码和传真号码，以便联繫以获取有关事件的任何讯息。
．製造商或进口商注意到该事件的日期。
．已知的有关事件的详细讯息，包括事件发生的日期以及对患者、用户或其他人造成的后果。
．向製造商或进口商报告事件的人员的姓名、地址和电话号码（如果知道）。
．事件中涉及的任何其他医疗设备或配件的身份（如果已知）。
．製造商或进口商对事件的初步评论。
．製造商或进口商提议就该事件採取的行动方针，包括调查，以及採取任何拟议行动和提交最终报告的时间表。
．声明，表明之前是否已向部长提交过有关该设备的报告，如果是，则报告的日期。

2. 最终报告
   ．对事件的描述，包括健康状况严重恶化或死亡的人数。
   ．详细解释事件原因以及就该事件採取行动的理由。
   ．因调查而採取的任何行动（例如：加强对器材的上市后监管、设备设计和製造的纠正和预防措施、召回等)。
   3.注意
   ．医疗器材製造商可以允许器材进口商代表製造商准备和提交初步和最终报告，如果製造商和进口商提供的讯息必须包含相同的内容。
   ．如果製造商允许进口商代表製造商准备和提交报告，则製造商应书面通知卫生部。

Yes, the business agent needs to have a business license, which is a Medical Device Enterprise License (MDEL).

1.Webpage: Submit the application by email.
mdel.application.leim@hc-sc.gc.ca
2.Application materials:
Application Form (FRM-0292):
．Organization Name: The legal name of the individual.
．Business Name, Trading Name, or Partnership Name: Any other business name (same legal entity as applicant) owned by the applicant, if applicable.
．Small Business: Indicate whether you are a small business. If you meet the small business definition, you may be eligible for a fee waiver.
．Government Organization: Indicate whether you are a government organization. All applications submitted by any branch or agency of the Government of Canada or a province or territory are exempt from payment of the fee.
．Set up address
．Business Number ( BN )
．Contact: The Department of Health will send an annual license review packet to the business license contact. The required information is the business representative’s name, title and phone number, e-mail, in order to contact.
．Mailing address, billing address
．Activities: Select each activity and medical device category as applicable to the operation.
．Site: the location and location of each activity stage.
．Manufacturer or Supplier Information
．Importers and/or Distributors of Class I Medical Devices: Please provide the name and complete address of the Class I medical device you will be importing or distributing
．Importers and/or Distributors of Class II, III, or IV Medical Devices: Must search the Medical Device Valid License List (MDALL) database for all manufacturers of Class II, III, or IV medical devices with a medical device license to confirm manufacture The dealer has been licensed for all classes of device that you will import and/or distribute (sell).
．Certification: Documentation from a senior company official confirming each statement and signing it.
．Sign.

3. Pay attention
   ．A Medical Device Establishment License (MDEL) application must list each manufacturer’s or supplier’s class of medical device that it plans to import or distribute in Canada.
   ．As an importer or distributor of medical devices in Canada, it is your responsibility to contact the manufacturer for more information if you are unsure of the classification of a medical device intended for sale or imported into Canada for human use.
   ．If a medical device falls into more than one category, the higher risk category applies. For example, when a medical device is classified into Class III and Class IV at the same time, the final classification of the medical device is Class IV.

Product responsibility
Manufacturers and importers of medical device are responsible for medical device. When safety incidents or quality problems occur, manufacturers and importers must submit reports to the Ministry of Health and take corresponding measures.

1. Preliminary report
   ．The name of the device and its designation, including: a system, test kit, medical device group, medical device family, or any medical device that is part of a medical device group family.
   ．The name and address of the manufacturer, such manufacturer and any known importers, and the name, title, telephone number, and fax number of the manufacturer’s representative who may be contacted for any information concerning the incident.
   ．The name and address of the importer, importer, and manufacturer of the device, and the name, title, telephone number, and fax number of the importer’s representative who may be contacted for any information concerning the incident.
   ．The date on which the event was brought to the attention of the manufacturer or importer.
   ．Details of what is known about the event, including the date it occurred and the consequences for the patient, user, or others.
   ．The name, address, and telephone number (if known) of the person who reported the incident to the manufacturer or importer.
   ．The identity of any other medical device or accessories involved in the incident, if known.
   ．Preliminary comments by the manufacturer or importer on the event.
   ．A proposed course of action by the manufacturer or importer regarding the incident, including an investigation, and a timeline for any proposed action and final report.
   ．A statement indicating whether there has been a previous report to the Minister regarding the device and, if so, the date of the report.
2. Final report
   ．A description of the event, including the number of people who suffered severe health deterioration or died.
   ．Explain in detail the cause of the incident and the rationale for the action taken regarding the incident.
   ．Any actions taken as a result of the investigation (eg, enhanced post-market surveillance of the device, corrective and preventive actions in device design and manufacture, recall, etc.).
3. Pay attention
   ．Medical device manufacturers may allow device importers to prepare and submit preliminary and final reports on behalf of the manufacturer, if the information provided by the manufacturer and importer must contain the same content.
   ．If the manufacturer allows the importer to prepare and submit a report on behalf of the manufacturer, the manufacturer shall notify the Ministry of Health in writing.

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html#_Establishment_licence_exemptions
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-5.html#docCont

HLF-TW-35

HLF-TW-40
外国公司销售到加拿大医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to Canadas? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
I类医疗器材不需要产品许可，II，III，IV类需要申请医疗器材许可证(MDL)。
医疗器材许可证 (MDL)：II 类、III 类和 IV 类医疗器材在加拿大进口或销售之前必须获得许可。只要满足医疗器材法规的要求，每提交一份申请就会向器材製造商颁发许可证 。

1.网页：
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
2.申请方式：电子邮件发送至医疗器材许可服务局
devicelicensing-homologationinstruments@hc-sc.gc.ca
3.必要资料
．设备名称
．设备类别
．标示符号，包括：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材的标示符号
．设备标籤上显示的製造商名称和地址
．製造企业的名称、地址
II类医疗器材
．製造、销售或代表该设备的医疗状况、目的和用途的描述
．设备製造过程中遵守的标准清单
．製造商提供客观证据证明
．设备标籤副本
．人体试验的研究测试(如果有)
．品质管理系统证书副本(需符合加拿大国家标准 CAN/CSA-ISO 13485 医疗器材-品质管理系统-要求监管目的)
III类医疗器材
．设备及其製造和包装所用材料的描述
．允许其用于其製造、销售或代表的医疗条件、目的和用途的器材特徵的描述
．除加拿大以外已销售该设备的国家/地区列表、在这些国家/地区销售的设备总数以及报告的任何设备问题和在这些国家/地区的任何设备召回的摘要
．设备设计和製造过程中遵守的标准清单
．无菌器材所用灭菌方法的描述
．研究支持文献摘要
．设备标籤副本
．人体试验的研究测试、总结
．所有已发表的有关该装置的使用、安全性和有效性的报告的参考书目
．品质管理系统证书副本，证明设备设计和製造所依据的品质管理系统符合加拿大国家标准 CAN/CSA-ISO 13485医疗器材-品质管理系统-中规定的要求
IV类医疗器材
．设备及其製造和包装所用材料的描述
．允许其用于其製造、销售或代表的医疗条件、目的和用途的器材特徵的描述
．除加拿大以外已销售该设备的国家/地区列表、在这些国家/地区销售的设备总数以及报告的任何设备问题和在这些国家/地区的任何设备召回的摘要
．风险分析、评估和措施
．具体品质控制计画、资源和活动顺序
．器材製造和包装所用材料的规格
．装置的製造过程
．设备设计和製造过程中遵守的标准清单
．製造商所依赖的所有研究的详细资料
．临床前和临床研究
．工艺验证研究
．软体验证研究、文学研究(如果有)
．对于由动物或人体组织或其衍生物製造或结合的体外诊断设备以外的医疗设备，该设备的生物安全性的客观证据
．如果是靠近患者的体外诊断设备，则使用代表预期用户的人体受试者并在与使用条件类似的条件下对该设备进行研究测试的详细讯息
．研究摘要以及製造商从这些研究中得出的结论
．所有已发表的有关该装置的使用、安全性和有效性的报告的参考书目
．设备标籤副本
．品质管理系统证书副本，证明设备设计和製造所依据的品质管理系统符合加拿大国家标准 CAN/CSA-ISO 13485医疗器材-品质管理系统-中规定的要求
4.国外厂商：
如果医疗器材许可证申请由加拿大以外国家的製造商提交，须确保
品质管理系统证书是受加拿大卫生部认可的监管机构管辖。

标籤
进口或销售医疗器材的标籤必须有以下资讯：
1.设备名称。
2.製造商的名称和地址。
3.器材的标示符号，包含：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材。
4.III类或 IV类设备，需标示控制编号。
5.如果内容不明显，则以适合该器材的术语表达包装中所包含的内容，例如：尺寸、淨重、长度、体积或单位数量等。
6.无菌产品应标示无菌一词。
7.由製造商根据预计使用寿命订定的设备失效日期（如果有）。
8.製造、销售或代表该设备的医疗状况、目的和用途，以及该设备的性能规格。
9.使用说明、安全使用方式。
10.适用于该设备的任何特殊储存条件。
11.确保标籤列于包含该装置的包装外部。

注意
1.所以标示的讯息要清晰、永久和明显的方式，并使用目标用户容易理解的用语，并在正常销售条件下清晰可见。
2.任何进口未按照本条例贴标籤的医疗器材进行销售的人应确保于销售医疗器材前，自进口之日起三个月内依规定重新贴标。
3.如果包含医疗器材的包装太小而无法显示所有讯息，则使用说明应附在器材上，但无需列在包装外部或在正常情况下可见。销售条件。
4.标籤讯息应採用英语和法语。

Class I medical devices do not require a product license, and Class II, III, and IV need to apply for a medical device license (MDL).
Medical Device License (MDL): Class II, III, and IV medical devices must be licensed before being imported or sold in Canada. A license is issued to the device manufacturer with each application submitted, as long as the requirements of the medical device regulations are met.

1. URL:
   https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
2. How to apply:
   Send an email to the Medical Device Licensing Service Bureau
   devicelicensing-homologationinstruments@hc-sc.gc.ca
3. Necessary documents
   ．Device name
   ．Device category
   ．Designation symbols, including: designation symbols for systems, test kits, medical device groups, medical device families, or any medical device that is part of a medical device group family
   ．Manufacturer’s name and address as shown on the device label
   ．Manufacturer’s name and address
   Class II medical device
   ．A description of the medical condition, purpose and use for which the device is manufactured, sold or represented
   ．List of standards followed during device manufacturing
   ．Manufacturer provides objective evidence that
   ．Copy of device label
   ．Research testing for human trials (if any)
   ．Copy of Quality Management System Certificate (need to comply with Canadian National Standard CAN/CSA-ISO 13485 Medical Devices – Quality Management System – Requirements for regulatory purposes)
   Class III medical device
   ．A description of the device and the materials used in its manufacture and packaging
   ．A description of the characteristics of the device that permits its use for the medical conditions, purposes and uses for which it is manufactured, sold or represented
   ．A list of countries other than Canada where the device has been sold, the total number of devices sold in those countries, and a summary of any reported device issues and any device recalls in those countries
   ．List of standards to be followed during device design and manufacture
   ．Description of the sterilization method used for sterile device
   ．Abstracts of Research Supporting Literature
   ．Copy of device label
   ．Human Trials Research Tests, Summary
   ．Bibliography of all published reports on the use, safety and efficacy of the device
   ．A copy of the quality management system certificate certifying that the quality management system under which the device was designed and manufactured complies with the requirements set out in the Canadian National Standard CAN/CSA-ISO 13485 Medical devices – Quality management systems
   Class IV Medical Devices
   ．A description of the device and the materials used in its manufacture and packaging
   ．A description of the characteristics of the device allowing it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented
   ．A list of countries other than Canada where the device has been sold, the total number of devices sold in those countries, and a summary of any reported device issues and any device recalls in those countries
   ．Risk analysis, assessment and measures
   ．Specific quality control plan, resources, and sequence of activities
   ．Specifications for materials used in device manufacture and packaging
   ．Manufacturing process of the device
   ．List of standards to be followed during device design and manufacture
   ．Details of all studies relied upon by the manufacturer
   ．Preclinical and Clinical Research
   ．Process Validation Studies
   ．Software verification studies, literature studies (if available)
   ．For medical devices other than in vitro diagnostic devices manufactured or incorporated from animal or human tissue or their derivatives, objective evidence of the biosafety of the device
   ．In the case of an in vitro diagnostic device near the patient, details of research testing of the device using human subjects representative of the intended user and under conditions similar to those of use
   ．Summary of studies and conclusions drawn by manufacturers from these studies
   ．Bibliography of all published reports on the use, safety and efficacy of the device
   ．Copy of device label
   ．A copy of the quality management system certificate certifying that the quality management system under which the device was designed and manufactured complies with the requirements set out in the Canadian National Standard CAN/CSA-ISO 13485 Medical devices – Quality management systems
4. Foreign manufacturers:
   If an application for a medical device license is submitted by a manufacturer from a country other than Canada, ensure that
   The Quality Management System Certificate is under the jurisdiction of a regulatory body recognized by Health Canada.

Label
Labels for imported or sold medical devices must include the following information:

1. Device name.
2. The name and address of the manufacturer.
3. The designation symbol for the device, including: any medical device that is part of a system, test kit, medical device group, medical device family, or medical device group family.
4. For Class III or Class IV device, the control number must be marked.
5. If the content is not obvious, express the content contained in the package in terms appropriate to the device, such as: size, net weight, length, volume or unit quantity, etc.
6. Sterile products should be marked with the word sterile.
7. Expiration date (if any) for the device based on the expected service life established by the manufacturer.
8. Manufacture, sell or represent the medical condition, purpose and use of this device, and the performance specifications of this device.
9. Instructions for use and safe use methods.
10. Any special storage conditions applicable to the device.
11. Make sure the label is listed on the outside of the package containing the device.

Notice

1. Therefore, the marked message should be clear, permanent and conspicuous, and use the language that the target users can easily understand, and be clearly visible under normal sales conditions.
2. Any person who imports medical device that has not been labeled in accordance with this Regulation for sale shall ensure that the medical device is relabeled within three months from the date of importation before selling the medical device.
3. If the package containing the medical device is too small to display all the information, the instructions for use shall be attached to the device, but need not be listed on the outside of the package or be normally visible. Conditions of Sale.
4. Label information should be in English and French.

【参考连结】
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html#h-1021414
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html#h-1021414

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
可以，前提是外国公司在申请前须确保品质管理系统证书是受加拿大卫生部认可的监管机构管辖。
I类医疗器材不需要产品许可，II，III，IV类需要申请医疗器材许可证(MDL)。
医疗器材许可证 (MDL)：II 类、III 类和 IV 类医疗器材在加拿大进口或销售之前必须获得许可。只要满足医疗器材法规的要求，每提交一份申请就会向器材製造商颁发许可证 。

1.网页：
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
2.申请方式：电子邮件发送至医疗器材许可服务局
devicelicensing-homologationinstruments@hc-sc.gc.ca
3.必要资料
．设备名称
．设备类别
．标示符号，包括：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材的标示符号
．设备标籤上显示的製造商名称和地址
．製造企业的名称、地址
II类医疗器材
．製造、销售或代表该设备的医疗状况、目的和用途的描述
．设备製造过程中遵守的标准清单
．製造商提供客观证据证明
．设备标籤副本
．人体试验的研究测试(如果有)
．品质管理系统证书副本(需符合加拿大国家标准 CAN/CSA-ISO 13485 医疗器材-品质管理系统-要求监管目的)
III类医疗器材
．设备及其製造和包装所用材料的描述
．允许其用于其製造、销售或代表的医疗条件、目的和用途的器材特徵的描述
．除加拿大以外已销售该设备的国家/地区列表、在这些国家/地区销售的设备总数以及报告的任何设备问题和在这些国家/地区的任何设备召回的摘要
．设备设计和製造过程中遵守的标准清单
．无菌器材所用灭菌方法的描述
．研究支持文献摘要
．设备标籤副本
．人体试验的研究测试、总结
．所有已发表的有关该装置的使用、安全性和有效性的报告的参考书目
．品质管理系统证书副本，证明设备设计和製造所依据的品质管理系统符合加拿大国家标准 CAN/CSA-ISO 13485医疗器材-品质管理系统-中规定的要求
IV类医疗器材
．设备及其製造和包装所用材料的描述
．允许其用于其製造、销售或代表的医疗条件、目的和用途的器材特徵的描述
．除加拿大以外已销售该设备的国家/地区列表、在这些国家/地区销售的设备总数以及报告的任何设备问题和在这些国家/地区的任何设备召回的摘要
．风险分析、评估和措施
．具体品质控制计画、资源和活动顺序
．器材製造和包装所用材料的规格
．装置的製造过程
．设备设计和製造过程中遵守的标准清单
．製造商所依赖的所有研究的详细资料
．临床前和临床研究
．工艺验证研究
．软体验证研究、文学研究(如果有)
．对于由动物或人体组织或其衍生物製造或结合的体外诊断设备以外的医疗设备，该设备的生物安全性的客观证据
．如果是靠近患者的体外诊断设备，则使用代表预期用户的人体受试者并在与使用条件类似的条件下对该设备进行研究测试的详细讯息
．研究摘要以及製造商从这些研究中得出的结论
．所有已发表的有关该装置的使用、安全性和有效性的报告的参考书目
．设备标籤副本
．品质管理系统证书副本，证明设备设计和製造所依据的品质管理系统符合加拿大国家标准 CAN/CSA-ISO 13485医疗器材-品质管理系统-中规定的要求
4.国外厂商：
如果医疗器材许可证申请由加拿大以外国家的製造商提交，须确保
品质管理系统证书是受加拿大卫生部认可的监管机构管辖。

标籤
进口或销售医疗器材的标籤必须有以下资讯：
1.设备名称。
2.製造商的名称和地址。
3.器材的标示符号，包含：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材。
4.III类或 IV类设备，需标示控制编号。
5.如果内容不明显，则以适合该器材的术语表达包装中所包含的内容，例如：尺寸、淨重、长度、体积或单位数量等。
6.无菌产品应标示无菌一词。
7.由製造商根据预计使用寿命订定的设备失效日期（如果有）。
8.製造、销售或代表该设备的医疗状况、目的和用途，以及该设备的性能规格。
9.使用说明、安全使用方式。
10.适用于该设备的任何特殊储存条件。
11.确保标籤列于包含该装置的包装外部。

注意
1.所以标示的讯息要清晰、永久和明显的方式，并使用目标用户容易理解的用语，并在正常销售条件下清晰可见。
2.任何进口未按照本条例贴标籤的医疗器材进行销售的人应确保于销售医疗器材前，自进口之日起三个月内依规定重新贴标。
3.如果包含医疗器材的包装太小而无法显示所有讯息，则使用说明应附在器材上，但无需列在包装外部或在正常情况下可见。销售条件。
4.标籤讯息应採用英语和法语。

Yes, but foreign companies must ensure that the quality management system certificate is under the jurisdiction of a regulatory agency recognized by Health Canada before applying.

Class I medical devices do not require a product license, and Class II, III, and IV need to apply for a medical device license (MDL).
Medical Device License (MDL): Class II, III, and IV medical devices must be licensed before being imported or sold in Canada. A license is issued to the device manufacturer with each application submitted, as long as the requirements of the medical device regulations are met.

1. URL:
   https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
2. How to apply:
   Send an email to the Medical Device Licensing Service Bureau
   devicelicensing-homologationinstruments@hc-sc.gc.ca
3. Necessary documents
   ．Device name
   ．Device category
   ．Designation symbols, including: designation symbols for systems, test kits, medical device groups, medical device families, or any medical device that is part of a medical device group family
   ．Manufacturer’s name and address as shown on the device label
   ．Manufacturer’s name and address
   Class II medical device
   ．A description of the medical condition, purpose and use for which the device is manufactured, sold or represented
   ．List of standards followed during device manufacturing
   ．Manufacturer provides objective evidence that
   ．Copy of device label
   ．Research testing for human trials (if any)
   ．Copy of Quality Management System Certificate (need to comply with Canadian National Standard CAN/CSA-ISO 13485 Medical Devices – Quality Management System – Requirements for regulatory purposes)
   Class III medical device
   ．A description of the device and the materials used in its manufacture and packaging
   ．A description of the characteristics of the device that permits its use for the medical conditions, purposes and uses for which it is manufactured, sold or represented
   ．A list of countries other than Canada where the device has been sold, the total number of devices sold in those countries, and a summary of any reported device issues and any device recalls in those countries
   ．List of standards to be followed during device design and manufacture
   ．Description of the sterilization method used for sterile device
   ．Abstracts of Research Supporting Literature
   ．Copy of device label
   ．Human Trials Research Tests, Summary
   ．Bibliography of all published reports on the use, safety and efficacy of the device
   ．A copy of the quality management system certificate certifying that the quality management system under which the device was designed and manufactured complies with the requirements set out in the Canadian National Standard CAN/CSA-ISO 13485 Medical devices – Quality management systems
   Class IV Medical Devices
   ．A description of the device and the materials used in its manufacture and packaging
   ．A description of the characteristics of the device allowing it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented
   ．A list of countries other than Canada where the device has been sold, the total number of devices sold in those countries, and a summary of any reported device issues and any device recalls in those countries
   ．Risk analysis, assessment and measures
   ．Specific quality control plan, resources, and sequence of activities
   ．Specifications for materials used in device manufacture and packaging
   ．Manufacturing process of the device
   ．List of standards to be followed during device design and manufacture
   ．Details of all studies relied upon by the manufacturer
   ．Preclinical and Clinical Research
   ．Process Validation Studies
   ．Software verification studies, literature studies (if available)
   ．For medical devices other than in vitro diagnostic devices manufactured or incorporated from animal or human tissue or their derivatives, objective evidence of the biosafety of the device
   ．In the case of an in vitro diagnostic device near the patient, details of research testing of the device using human subjects representative of the intended user and under conditions similar to those of use
   ．Summary of studies and conclusions drawn by manufacturers from these studies
   ．Bibliography of all published reports on the use, safety and efficacy of the device
   ．Copy of device label
   ．A copy of the quality management system certificate certifying that the quality management system under which the device was designed and manufactured complies with the requirements set out in the Canadian National Standard CAN/CSA-ISO 13485 Medical devices – Quality management systems
4. Foreign manufacturers:
   If an application for a medical device license is submitted by a manufacturer from a country other than Canada, ensure that
   The Quality Management System Certificate is under the jurisdiction of a regulatory body recognized by Health Canada.

Label
Labels for imported or sold medical devices must include the following information:

1. Device name.
2. The name and address of the manufacturer.
3. The designation symbol for the device, including: any medical device that is part of a system, test kit, medical device group, medical device family, or medical device group family.
4. For Class III or Class IV device, the control number must be marked.
5. If the content is not obvious, express the content contained in the package in terms appropriate to the device, such as: size, net weight, length, volume or unit quantity, etc.
6. Sterile products should be marked with the word sterile.
7. Expiration date (if any) for the device based on the expected service life established by the manufacturer.
8. Manufacture, sell or represent the medical condition, purpose and use of this device, and the performance specifications of this device.
9. Instructions for use and safe use methods.
10. Any special storage conditions applicable to the device.
11. Make sure the label is listed on the outside of the package containing the device.

Notice

1. Therefore, the marked message should be clear, permanent and conspicuous, and use the language that the target users can easily understand, and be clearly visible under normal sales conditions.
2. Any person who imports medical device that has not been labeled in accordance with this Regulation for sale shall ensure that the medical device is relabeled within three months from the date of importation before selling the medical device.
3. If the package containing the medical device is too small to display all the information, the instructions for use shall be attached to the device, but need not be listed on the outside of the package or be normally visible. Conditions of Sale.
4. Label information should be in English and French.

【参考连结】
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html#h-1021414
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html
https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html#h-1021414

HLF-TW-55

HLF-TW-60
经过核准登记的医疗器材，进口到加拿大要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into Canadas? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
须先完成产品许可证(医疗器材许可证MDL)、营业许可证(医疗器材企业许可证MDEL)。

医疗器材商业进口须具备以下文件
1.具备医疗器材许可证（MDL）
2.授权或许可供应商/进口商的发票/海关文件
3.进口商必须拥有开展进口活动的营业许可证(医疗器材企业许可证MDEL)。

4. 海关发票
5. 销售确认书 (COS)：联繫人姓名、地址、城市、州/省、邮政编码、电话号码、传真号码、电子邮件地址等。
6. 形式发票：当商业发票或加拿大海关发票不可用时，可以使用形式发票。
7. CUSMA原产地认证：仅适用于来自加拿大、美国和/或墨西哥且价值超过 3,300 加元的合格货物，根据新的北美自由贸易协定要求进入加拿大的合格商业商品降低关税。
8. ACI 电子舱单：保税仓库地点、航班资讯、成员资料、省/州/国家、交通工具车牌号、拖车车牌号码、运输单位数量、拖车单位号、报关行、托运人姓名和地址、收货人姓名和地址、託运商品完整描述、数量和重量等。
9. PARS通知(加拿大境内货件通知) ：预计抵达入境口岸的时间、物流讯息、进口商名称、件数、包装类型、重量、承运人名称、调度电话、司机姓名、司机电话号码等。

无另行销售通知。
Product license (Medical Device License MDL) and business license (Medical Device Enterprise License MDEL) must be completed.

Commercial import of medical device must have the following documents

1. Possess medical device license (MDL)
2. Invoices/customs documents from authorized or licensed suppliers/importers
3. The importer must have a business license to carry out import activities (Medical Device Enterprise License MDEL).
4. Customs Invoice
5. Confirmation of Sale (COS): Contact name, address, city, state/province, zip code, phone number, fax number, email address, etc.
6. Proforma Invoice: Proforma Invoice can be used when Commercial Invoice or Canadian Customs Invoice are not available.
7. CUSMA Origin Certification: Applicable only to qualified goods from Canada, the United States and/or Mexico with a value of more than 3,300 Canadian dollars, reduced tariffs for qualified commercial goods entering Canada under the new North American Free Trade Agreement requirements.
8. ACI electronic manifest: bonded warehouse location, flight information, member information, province/state/country, vehicle license plate number, trailer license plate number, transport unit quantity, trailer unit number, customs broker, shipper’s name and address, receipt The name and address of the consignor, the complete description, quantity and weight of the consigned goods, etc.
9. PARS notification (shipment notification in Canada): estimated time of arrival at the port of entry, logistics information, importer name, number of pieces, packaging type, weight, carrier name, dispatch phone number, driver name, driver phone number, etc.

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/commercial-use-health-products-guidance/document.html#sec5
https://www.cbsa-asfc.gc.ca/menu-eng.html

HLF-TW-70
加拿大医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
品质系统 ISO 13485
1.加拿大卫生部仅接受由加拿大医疗器材合格评定系统 (CMDCAS) 认可註册机构的特殊第三方审核组织颁发的品质系统证书。医疗器材进口商或经销商则无须申请註册品质系统。
2.医疗器材法规要求 II、III 和 IV 类医疗器材根据 CAN/CSA ISO 13485:2003 製造（II 类）或设计和製造（III 类和 IV 类）。I 类医疗器材没有监管品质系统要求。

3. 认可註册商名单
   https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/list-registrars-recognized-under-section-32-1-medical-devices-regulations.html
4. 作为加拿大医疗器材合格评定系统 (CMDCAS) 的一部分生成的报告应採用法语或英语，或者根据监管机构的要求以任一语言提供。
5. 报告内容
   製造商
   ．製造商名称和地址
   ．公司识别号
   ．製造商的企业形象
   ．製造商描述
   ．认证范围
   ．关键供应商的识别
   ．品质管理系统联繫人
   ．任何相关QMS认证的状态
   审核讯息
   ．审核类型
   ．审核标准
   ．审核目标
   ．製造商品质管理系统符合ISO 13485:2003的评估
   ．审核范围
   ．审核日期
   ．审核组的身份
   ．审核语言
   ．文件审查结果
   审核结果
   ．审核摘要
   ．主要变更说明
   ．障碍
   ．对过去不合格情况的追踪
   ．不合格项
   ．未审核领域
   结论
   ．符合审核标准
   ．效力
   ．审核目标的确认
   ．审核的可靠性
   ．建议
   鑑定和年代测定
   ．报告作者的姓名
   ．最终发布日期

Quality System ISO 13485

1. Health Canada only accepts quality system certificates issued by special third-party audit organizations known as Canadian Medical Device Conformity Assessment System (CMDCAS) Accredited Registries. Importers or distributors of medical devices are not required to have a registered quality system.
2. Medical device regulations require Class II, III and IV medical devices to be manufactured (Class II) or designed and manufactured (Class III and IV) in accordance with CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices.
3. List of Accredited Registrars
   https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/list-registrars-recognized-under-section-32-1-medical-devices-regulations.html
4. Reports generated as part of the Canadian Medical Device Conformity Assessment System (CMDCAS) shall be in French or English, or in either language as required by the regulatory authority.
5. Report content
   Manufacturer
   ．Manufacturer’s name and address
   ．Company identification number
   ．Manufacturer’s corporate identity
   ．Manufacturer description
   ．Certification scope
   ．Identification of key suppliers
   ．Quality Management System Contact
   ．Status of any relevant QMS certification
   Moderate message
   ．Audit type
   ．Audit Standard
   ．Audit objectives
   ．Assessment of the manufacturer’s quality management system in Compliance with ISO 13485:2003
   ．Audit scope
   ．Review date
   ．Identity of the audit team
   ．Auditing language
   ．Document Review Results
   Audit results
   ．Summary
   ．Major Change Description
   ．Obstacle
   ． Follow-up on past non-conformities
   ．Unqualified items
   ．Unaudited areas
   Conclusion
   ．Compliance with Audit Standards
   ．Effectiveness
   ．Confirmation of audit objectives
   ．Auditing Reliability
   ．Suggestion
   Identification and dating
   ．Report author’s name
   ．Final publication date

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/guidance-document-gd211-guidance-quality-management-system-audit-reports.html#a2.3.1

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口医疗器材后，如果委託加拿大的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in Canadas to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
需要，经销商需具备营业许可证，也就是医疗器材企业许可证(MDEL)。

1.网页：通过电子邮件提交申请。
mdel.application.leim@hc-sc.gc.ca
2.申请资料：
申请表 (FRM-0292)：
．机构名称：个人的法定名称。
．经营名称、贸易名称或合伙名称：申请人拥有的任何其他公司名称（与申请人相同的法律实体）（如适用）。
．小型企业：表明您是否是小型企业。如果您符合小型企业定义，可能有资格获得费用减免。
．政府组织：表明您是否是政府组织。加拿大政府或省或地区的任何分支机构或机构提交的所有申请均免缴费用。
．设立地址
．企业号码 ( BN )
．联繫人：卫生部会将年度许可证审查包发送给企业许可证联繫人。所需讯息是企业代表的姓名、职务和电话号码、电子邮件，以便联繫。
．邮寄地址、账单地址
．活动：选取适用于运营的每项活动和医疗设备类别。
．站点：每个活动阶段位置、地点。
．製造商或供应商讯息
．I 类医疗器材的进口商和/或分销商：请提供您将进口或分销的 I 类医疗器材的的名称和完整地址
．II、III 或 IV 类医疗器材的进口商和/或经销商：必须在医疗器材有效许可证列表( MDALL ) 数据库中搜索所有II、III 或IV 类医疗器材医疗器材许可证的製造商，确认製造商已获得您将进口和/或分销（销售）的所有类别设备的许可。
．证明：公司高级官员的证明文件，确认每份声明并签署。
．签名。
3.注意
．医疗器材企业许可证 (MDEL) 申请必须列出计划在加拿大进口或分销的每个製造商或供应商的医疗器材类别。
．作为加拿大医疗器材的进口商或经销商，如果不确定打算出售或进口到加拿大供人使用的医疗器材的分类，您有责任联繫製造商以获取更多讯息。
．如果医疗器材属于多个类别，则适用较高的风险类别。例如，当某医疗器材同时被分类为第三类和第四类时，该医疗器材的最终分类为第四类。

产品责任
医疗器材的製造商、进口商有责任对医疗器材负责，当发生安全事件、品质问题，製造商和进口商需向卫生部提交报告及採取因应措施。

1.初步报告
．器材名称及其标示，包括：系统、测试套件、医疗器材组、医疗器材系列或医疗器材组系列一部分的任何医疗器材。
．製造商、该製造商和任何已知进口商的名称和地址，以及製造商代表的姓名、职务、电话号码和传真号码，以便联繫以获取有关该事件的任何讯息。
．器材的进口商、进口商和製造商的名称和地址，以及进口商代表的姓名、职务、电话号码和传真号码，以便联繫以获取有关事件的任何讯息。
．製造商或进口商注意到该事件的日期。
．已知的有关事件的详细讯息，包括事件发生的日期以及对患者、用户或其他人造成的后果。
．向製造商或进口商报告事件的人员的姓名、地址和电话号码（如果知道）。
．事件中涉及的任何其他医疗设备或配件的身份（如果已知）。
．製造商或进口商对事件的初步评论。
．製造商或进口商提议就该事件採取的行动方针，包括调查，以及採取任何拟议行动和提交最终报告的时间表。
．声明，表明之前是否已向部长提交过有关该设备的报告，如果是，则报告的日期。

2. 最终报告
   ．对事件的描述，包括健康状况严重恶化或死亡的人数。
   ．详细解释事件原因以及就该事件採取行动的理由。
   ．因调查而採取的任何行动（例如：加强对器材的上市后监管、设备设计和製造的纠正和预防措施、召回等)。
   3.注意
   ．医疗器材製造商可以允许器材进口商代表製造商准备和提交初步和最终报告，如果製造商和进口商提供的讯息必须包含相同的内容。
   ．如果製造商允许进口商代表製造商准备和提交报告，则製造商应书面通知卫生部。

Yes, dealers need to have a business license, that is, a medical device enterprise license (MDEL).

1.Webpage: Submit the application by email.
mdel.application.leim@hc-sc.gc.ca
2.Application materials:
Application Form (FRM-0292):
．Organization Name: The legal name of the individual.
．Business Name, Trading Name, or Partnership Name: Any other business name (same legal entity as applicant) owned by the applicant, if applicable.
．Small Business: Indicate whether you are a small business. If you meet the small business definition, you may be eligible for a fee waiver.
．Government Organization: Indicate whether you are a government organization. All applications submitted by any branch or agency of the Government of Canada or a province or territory are exempt from payment of the fee.
．Set up address
．Business Number ( BN )
．Contact: The Department of Health will send an annual license review packet to the business license contact. The required information is the business representative’s name, title and phone number, e-mail, in order to contact.
．Mailing address, billing address
．Activities: Select each activity and medical device category as applicable to the operation.
．Site: the location and location of each activity stage.
．Manufacturer or Supplier Information
．Importers and/or Distributors of Class I Medical Devices: Please provide the name and complete address of the Class I medical device you will be importing or distributing
．Importers and/or Distributors of Class II, III, or IV Medical Devices: Must search the Medical Device Valid License List (MDALL) database for all manufacturers of Class II, III, or IV medical devices with a medical device license to confirm manufacture The dealer has been licensed for all classes of device that you will import and/or distribute (sell).
．Certification: Documentation from a senior company official confirming each statement and signing it.
．Sign.

3. Pay attention
   ．A Medical Device Establishment License (MDEL) application must list each manufacturer’s or supplier’s class of medical device that it plans to import or distribute in Canada.
   ．As an importer or distributor of medical devices in Canada, it is your responsibility to contact the manufacturer for more information if you are unsure of the classification of a medical device intended for sale or imported into Canada for human use.
   ．If a medical device falls into more than one category, the higher risk category applies. For example, when a medical device is classified into Class III and Class IV at the same time, the final classification of the medical device is Class IV.

Product responsibility
Manufacturers and importers of medical device are responsible for medical device. When safety incidents or quality problems occur, manufacturers and importers must submit reports to the Ministry of Health and take corresponding measures.

1. Preliminary report
   ．The name of the device and its designation, including: a system, test kit, medical device group, medical device family, or any medical device that is part of a medical device group family.
   ．The name and address of the manufacturer, such manufacturer and any known importers, and the name, title, telephone number, and fax number of the manufacturer’s representative who may be contacted for any information concerning the incident.
   ．The name and address of the importer, importer, and manufacturer of the device, and the name, title, telephone number, and fax number of the importer’s representative who may be contacted for any information concerning the incident.
   ．The date on which the event was brought to the attention of the manufacturer or importer.
   ．Details of what is known about the event, including the date it occurred and the consequences for the patient, user, or others.
   ．The name, address, and telephone number (if known) of the person who reported the incident to the manufacturer or importer.
   ．The identity of any other medical device or accessories involved in the incident, if known.
   ．Preliminary comments by the manufacturer or importer on the event.
   ．A proposed course of action by the manufacturer or importer regarding the incident, including an investigation, and a timeline for any proposed action and final report.
   ．A statement indicating whether there has been a previous report to the Minister regarding the device and, if so, the date of the report.
2. Final report
   ．A description of the event, including the number of people who suffered severe health deterioration or died.
   ．Explain in detail the cause of the incident and the rationale for the action taken regarding the incident.
   ．Any actions taken as a result of the investigation (eg, enhanced post-market surveillance of the device, corrective and preventive actions in device design and manufacture, recall, etc.).
3. Pay attention
   ．Medical device manufacturers may allow device importers to prepare and submit preliminary and final reports on behalf of the manufacturer, if the information provided by the manufacturer and importer must contain the same content.
   ．If the manufacturer allows the importer to prepare and submit a report on behalf of the manufacturer, the manufacturer shall notify the Ministry of Health in writing.

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html#_Establishment_licence_exemptions
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-5.html#docCont

HLF-TW-85

各国医疗器材登记法规问答集

Email：yto4ww@evershinecpa.com
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