加拿大醫療器材登記法規問答集 -

加拿大醫療器材登記法規問答集

加拿大主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。加拿大多倫多與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：yto4ww@evershinecpa.com
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時間：2022/07/28 drafted by Yvonne Chen

文章目錄 點擊收合

HLF-TW-10請問加拿大對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

HLF-TW-20外國公司要到加拿大銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

HLF-TW-30外國公司要到加拿大銷售醫療器材，可以指派加拿大公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

HLF-TW-40外國公司銷售到加拿大醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

HLF-TW-50外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

HLF-TW-60經過核准登記的醫療器材，進口到加拿大要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

HLF-TW-70加拿大醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-TW-80外國子公司進口醫療器材後，如果委託加拿大的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

各國醫療器材登記法規問答集

HLF-TW-10
請問加拿大對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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，健康衛生部(HC)是醫療器材的主管部門，其中的醫療器材管理局 (MDD) 是監測和評估加拿大診斷和治療醫療器材的安全性、有效性和品質的國家機構，MDD 確保在加拿大銷售的醫療器材符合安全性、有效性和品質要求。

醫療器材是用於治療、診斷或預防疾病或異常身體狀況的任何儀器或材料，不包括用於動物或獸醫目的之設備。分類規則分為 I 類至 IV 類之一，其中 I 類代表最低風險，IV 類代表最高風險。如果醫療器材可以分為多個類別，則適用代表較高風險的類別。依據風險大小，產品註冊的要求也逐級增加，品質系統要求也是愈加詳盡。

1.醫療器材包括一系列健康產品，包括：
．繃帶/膠帶（I 類）
．拐杖和手杖（I類）
．牙刷-手動（I 類）
．牙刷-電動（II 類）
．助聽器（II類）
．髖關節植入物（III 類）
．呼吸器（III類）
．人造心臟（IV類）

醫療器材分類規則
．Ⅰ類：最低風險器材，例如：傷口護理和非外科侵入器材。
．Ⅱ類：低風險器材，例如：隱形眼鏡和大多數外科侵入器材；
．Ⅲ類：中等風險器材，例如：髖關節植入物，葡萄糖監測器和預期可被身體吸收或預期在身體中停留至少30個連續天的外科侵入器材。
．Ⅳ類：高風險器材，例如：心臟起搏器和用於診斷、控制心血管中樞系統的缺陷的外科侵入器材。
醫療器材分為以下四組：
．侵入器材
．非侵入器材
．有源器材
．特殊規則

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.

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)
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.
Medical devices are divided into the following four groups:
． Intrusion device
． Non-invasive device
． Active device
． Special rules

【參考連結】
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
外國公司要到加拿大銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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，一般來說，在加拿大進口或銷售醫療器材都需要取得醫療器材企業許可證(MDEL)。

1.網頁：通過電子郵件提交申請。
mdel.application.leim@hc-sc.gc.ca
2.申請資料：
申請表 (FRM-0292)：
．機構名稱：個人的法定名稱。
．經營名稱、貿易名稱或合夥名稱：申請人擁有的任何其他公司名稱（與申請人相同的法律實體）（如適用）。
．小型企業：表明您是否是小型企業。如果您符合小型企業定義，可能有資格獲得費用減免。
．政府組織：表明您是否是政府組織。加拿大政府或省或地區的任何分支機構或機構提交的所有申請均免繳費用。
．設立地址
．企業號碼 ( BN )
．聯繫人：衛生部會將年度許可證審查包發送給企業許可證聯繫人。所需訊息是企業代表的姓名、職務和電話號碼、電子郵件，以便聯繫。
．郵寄地址、賬單地址
．活動：選取適用於運營的每項活動和醫療設備類別。
．站點：每個活動階段位置、地點。
．製造商或供應商訊息
．I 類醫療器材的進口商和/或分銷商：請提供您將進口或分銷的 I 類醫療器材的的名稱和完整地址
．II、III 或 IV 類醫療器材的進口商和/或經銷商：必須在醫療器材有效許可證列表( MDALL ) 數據庫中搜索所有II、III 或IV 類醫療器材醫療器材許可證的製造商，確認製造商已獲得您將進口和/或分銷（銷售）的所有類別設備的許可。
．證明：公司高級官員的證明文件，確認每份聲明並簽署。
．簽名。
3.注意
．醫療器材企業許可證 (MDEL) 申請必須列出計劃在加拿大進口或分銷的每個製造商或供應商的醫療器材類別。
．作為加拿大醫療器材的進口商或經銷商，如果不確定打算出售或進口到加拿大供人使用的醫療器材的分類，您有責任聯繫製造商以獲取更多訊息。
．如果醫療器材屬於多個類別，則適用較高的風險類別。例如，當某醫療器材同時被分類為第三類和第四類時，該醫療器材的最終分類為第四類。

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.

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.

【參考連結】
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
外國公司要到加拿大銷售醫療器材，可以指派加拿大公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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，營業代理人需具備營業許可證，也就是醫療器材企業許可證(MDEL)。

產品責任
醫療器材的製造商、進口商有責任對醫療器材負責，當發生安全事件、品質問題，製造商和進口商需向衛生部提交報告及採取因應措施。

1.初步報告
．器材名稱及其標示，包括：系統、測試套件、醫療器材組、醫療器材系列或醫療器材組系列一部分的任何醫療器材。
．製造商、該製造商和任何已知進口商的名稱和地址，以及製造商代表的姓名、職務、電話號碼和傳真號碼，以便聯繫以獲取有關該事件的任何訊息。
．器材的進口商、進口商和製造商的名稱和地址，以及進口商代表的姓名、職務、電話號碼和傳真號碼，以便聯繫以獲取有關事件的任何訊息。
．製造商或進口商注意到該事件的日期。
．已知的有關事件的詳細訊息，包括事件發生的日期以及對患者、用戶或其他人造成的後果。
．向製造商或進口商報告事件的人員的姓名、地址和電話號碼（如果知道）。
．事件中涉及的任何其他醫療設備或配件的身份（如果已知）。
．製造商或進口商對事件的初步評論。
．製造商或進口商提議就該事件採取的行動方針，包括調查，以及採取任何擬議行動和提交最終報告的時間表。
．聲明，表明之前是否已向部長提交過有關該設備的報告，如果是，則報告的日期。

最終報告
．對事件的描述，包括健康狀況嚴重惡化或死亡的人數。
．詳細解釋事件原因以及就該事件採取行動的理由。
．因調查而採取的任何行動（例如：加強對器材的上市後監管、設備設計和製造的糾正和預防措施、召回等)。
3.注意
．醫療器材製造商可以允許器材進口商代表製造商準備和提交初步和最終報告，如果製造商和進口商提供的訊息必須包含相同的內容。
．如果製造商允許進口商代表製造商準備和提交報告，則製造商應書面通知衛生部。

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

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.

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.
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.).
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.

HLF-TW-35

HLF-TW-40
外國公司銷售到加拿大醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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類醫療器材不需要產品許可，II，III，IV類需要申請醫療器材許可證(MDL)。
醫療器材許可證 (MDL)：II 類、III 類和 IV 類醫療器材在加拿大進口或銷售之前必須獲得許可。只要滿足醫療器材法規的要求，每提交一份申請就會向器材製造商頒發許可證。

1.網頁：
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
2.申請方式：電子郵件發送至醫療器材許可服務局
devicelicensing-homologationinstruments@hc-sc.gc.ca
3.必要資料
．設備名稱
．設備類別
．標示符號，包括：系統、測試套件、醫療器材組、醫療器材系列或醫療器材組系列一部分的任何醫療器材的標示符號
．設備標籤上顯示的製造商名稱和地址
．製造企業的名稱、地址
II類醫療器材
．製造、銷售或代表該設備的醫療狀況、目的和用途的描述
．設備製造過程中遵守的標準清單
．製造商提供客觀證據證明
．設備標籤副本
．人體試驗的研究測試(如果有)
．品質管理系統證書副本(需符合加拿大國家標準 CAN/CSA-ISO 13485 醫療器材-品質管理系統-要求監管目的)
III類醫療器材
．設備及其製造和包裝所用材料的描述
．允許其用於其製造、銷售或代表的醫療條件、目的和用途的器材特徵的描述
．除加拿大以外已銷售該設備的國家/地區列表、在這些國家/地區銷售的設備總數以及報告的任何設備問題和在這些國家/地區的任何設備召回的摘要
．設備設計和製造過程中遵守的標準清單
．無菌器材所用滅菌方法的描述
．研究支持文獻摘要
．設備標籤副本
．人體試驗的研究測試、總結
．所有已發表的有關該裝置的使用、安全性和有效性的報告的參考書目
．品質管理系統證書副本，證明設備設計和製造所依據的品質管理系統符合加拿大國家標準 CAN/CSA-ISO 13485醫療器材-品質管理系統-中規定的要求
IV類醫療器材
．設備及其製造和包裝所用材料的描述
．允許其用於其製造、銷售或代表的醫療條件、目的和用途的器材特徵的描述
．除加拿大以外已銷售該設備的國家/地區列表、在這些國家/地區銷售的設備總數以及報告的任何設備問題和在這些國家/地區的任何設備召回的摘要
．風險分析、評估和措施
．具體品質控制計畫、資源和活動順序
．器材製造和包裝所用材料的規格
．裝置的製造過程
．設備設計和製造過程中遵守的標準清單
．製造商所依賴的所有研究的詳細資料
．臨床前和臨床研究
．工藝驗證研究
．軟體驗證研究、文學研究(如果有)
．對於由動物或人體組織或其衍生物製造或結合的體外診斷設備以外的醫療設備，該設備的生物安全性的客觀證據
．如果是靠近患者的體外診斷設備，則使用代表預期用戶的人體受試者並在與使用條件類似的條件下對該設備進行研究測試的詳細訊息
．研究摘要以及製造商從這些研究中得出的結論
．所有已發表的有關該裝置的使用、安全性和有效性的報告的參考書目
．設備標籤副本
．品質管理系統證書副本，證明設備設計和製造所依據的品質管理系統符合加拿大國家標準 CAN/CSA-ISO 13485醫療器材-品質管理系統-中規定的要求
4.國外廠商：
如果醫療器材許可證申請由加拿大以外國家的製造商提交，須確保
品質管理系統證書是受加拿大衛生部認可的監管機構管轄。

標籤
進口或銷售醫療器材的標籤必須有以下資訊：
1.設備名稱。
2.製造商的名稱和地址。
3.器材的標示符號，包含：系統、測試套件、醫療器材組、醫療器材系列或醫療器材組系列一部分的任何醫療器材。
4.III類或 IV類設備，需標示控制編號。
5.如果內容不明顯，則以適合該器材的術語表達包裝中所包含的內容，例如：尺寸、淨重、長度、體積或單位數量等。
6.無菌產品應標示無菌一詞。
7.由製造商根據預計使用壽命訂定的設備失效日期（如果有）。
8.製造、銷售或代表該設備的醫療狀況、目的和用途，以及該設備的性能規格。
9.使用說明、安全使用方式。
10.適用於該設備的任何特殊儲存條件。
11.確保標籤列於包含該裝置的包裝外部。

注意
1.所以標示的訊息要清晰、永久和明顯的方式，並使用目標用戶容易理解的用語，並在正常銷售條件下清晰可見。
2.任何進口未按照本條例貼標籤的醫療器材進行銷售的人應確保於銷售醫療器材前，自進口之日起三個月內依規定重新貼標。
3.如果包含醫療器材的包裝太小而無法顯示所有訊息，則使用說明應附在器材上，但無需列在包裝外部或在正常情況下可見。銷售條件。
4.標籤訊息應採用英語和法語。

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.

URL:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
How to apply:
Send an email to the Medical Device Licensing Service Bureau
devicelicensing-homologationinstruments@hc-sc.gc.ca
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
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:

Device name.
The name and address of the manufacturer.
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.
For Class III or Class IV device, the control number must be marked.
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.
Sterile products should be marked with the word sterile.
Expiration date (if any) for the device based on the expected service life established by the manufacturer.
Manufacture, sell or represent the medical condition, purpose and use of this device, and the performance specifications of this device.
Instructions for use and safe use methods.
Any special storage conditions applicable to the device.
Make sure the label is listed on the outside of the package containing the device.

Notice

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.
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.
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.
Label information should be in English and French.

【參考連結】
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
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

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，前提是外國公司在申請前須確保品質管理系統證書是受加拿大衛生部認可的監管機構管轄。
I類醫療器材不需要產品許可，II，III，IV類需要申請醫療器材許可證(MDL)。
醫療器材許可證 (MDL)：II 類、III 類和 IV 類醫療器材在加拿大進口或銷售之前必須獲得許可。只要滿足醫療器材法規的要求，每提交一份申請就會向器材製造商頒發許可證。

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.

URL:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
How to apply:
Send an email to the Medical Device Licensing Service Bureau
devicelicensing-homologationinstruments@hc-sc.gc.ca
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
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:

Device name.
The name and address of the manufacturer.
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.
For Class III or Class IV device, the control number must be marked.
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.
Sterile products should be marked with the word sterile.
Expiration date (if any) for the device based on the expected service life established by the manufacturer.
Manufacture, sell or represent the medical condition, purpose and use of this device, and the performance specifications of this device.
Instructions for use and safe use methods.
Any special storage conditions applicable to the device.
Make sure the label is listed on the outside of the package containing the device.

Notice

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.
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.
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.
Label information should be in English and French.

HLF-TW-55

HLF-TW-60
經過核准登記的醫療器材，進口到加拿大要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：
須先完成產品許可證(醫療器材許可證MDL)、營業許可證(醫療器材企業許可證MDEL)。

醫療器材商業進口須具備以下文件
1.具備醫療器材許可證（MDL）
2.授權或許可供應商/進口商的發票/海關文件
3.進口商必須擁有開展進口活動的營業許可證(醫療器材企業許可證MDEL)。

海關發票
銷售確認書 (COS)：聯繫人姓名、地址、城市、州/省、郵政編碼、電話號碼、傳真號碼、電子郵件地址等。
形式發票：當商業發票或加拿大海關發票不可用時，可以使用形式發票。
CUSMA原產地認證：僅適用於來自加拿大、美國和/或墨西哥且價值超過 3,300 加元的合格貨物，根據新的北美自由貿易協定要求進入加拿大的合格商業商品降低關稅。
ACI 電子艙單：保稅倉庫地點、航班資訊、成員資料、省/州/國家、交通工具車牌號、拖車車牌號碼、運輸單位數量、拖車單位號、報關行、托運人姓名和地址、收貨人姓名和地址、託運商品完整描述、數量和重量等。
PARS通知(加拿大境內貨件通知) ：預計抵達入境口岸的時間、物流訊息、進口商名稱、件數、包裝類型、重量、承運人名稱、調度電話、司機姓名、司機電話號碼等。

無另行銷售通知。
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

Possess medical device license (MDL)
Invoices/customs documents from authorized or licensed suppliers/importers
The importer must have a business license to carry out import activities (Medical Device Enterprise License MDEL).
Customs Invoice
Confirmation of Sale (COS): Contact name, address, city, state/province, zip code, phone number, fax number, email address, etc.
Proforma Invoice: Proforma Invoice can be used when Commercial Invoice or Canadian Customs Invoice are not available.
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.
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.
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.

【參考連結】
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
加拿大醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
品質系統 ISO 13485
1.加拿大衛生部僅接受由加拿大醫療器材合格評定系統 (CMDCAS) 認可註冊機構的特殊第三方審核組織頒發的品質系統證書。醫療器材進口商或經銷商則無須申請註冊品質系統。
2.醫療器材法規要求 II、III 和 IV 類醫療器材根據 CAN/CSA ISO 13485:2003 製造（II 類）或設計和製造（III 類和 IV 類）。I 類醫療器材沒有監管品質系統要求。

認可註冊商名單
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
作為加拿大醫療器材合格評定系統 (CMDCAS) 的一部分生成的報告應採用法語或英語，或者根據監管機構的要求以任一語言提供。
報告內容
製造商
．製造商名稱和地址
．公司識別號
．製造商的企業形象
．製造商描述
．認證範圍
．關鍵供應商的識別
．品質管理系統聯繫人
．任何相關QMS認證的狀態
審核訊息
．審核類型
．審核標準
．審核目標
．製造商品質管理系統符合ISO 13485:2003的評估
．審核範圍
．審核日期
．審核組的身份
．審核語言
．文件審查結果
審核結果
．審核摘要
．主要變更說明
．障礙
．對過去不合格情況的追蹤
．不合格項
．未審核領域
結論
．符合審核標準
．效力
．審核目標的確認
．審核的可靠性
．建議
鑑定和年代測定
．報告作者的姓名
．最終發布日期

Quality System ISO 13485

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.
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.
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
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.
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

【參考連結】
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
外國子公司進口醫療器材後，如果委託加拿大的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

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，經銷商需具備營業許可證，也就是醫療器材企業許可證(MDEL)。

產品責任
醫療器材的製造商、進口商有責任對醫療器材負責，當發生安全事件、品質問題，製造商和進口商需向衛生部提交報告及採取因應措施。

最終報告
．對事件的描述，包括健康狀況嚴重惡化或死亡的人數。
．詳細解釋事件原因以及就該事件採取行動的理由。
．因調查而採取的任何行動（例如：加強對器材的上市後監管、設備設計和製造的糾正和預防措施、召回等)。
3.注意
．醫療器材製造商可以允許器材進口商代表製造商準備和提交初步和最終報告，如果製造商和進口商提供的訊息必須包含相同的內容。
．如果製造商允許進口商代表製造商準備和提交報告，則製造商應書面通知衛生部。

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

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.

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.
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.).
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.

HLF-TW-85

各國醫療器材登記法規問答集

Email：yto4ww@evershinecpa.com
或
加拿大永輝BPO有限公司
接洽人:
Vincent Wang 加拿大籍来自台灣
或
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(版本:2022/03)

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