Canada medical device regulations QA -

Canada medical device regulations QA

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Email: yto4ww@evershinecpa.com
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ES CA , One of Evershine affiliates
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Whats App +886-989-808-249
wechatid: victoria141193

2022/07/28 drafted by Yvonne Chen

HLF-TW-10
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：
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

【Reference Link】
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
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：
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.

【Reference Link】
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
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：
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
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：
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.

【Reference Link】
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
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：
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.

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
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：
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.

【Reference Link】
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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

【Reference Link】
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
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：
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

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*International Tax Planning
*Company Registration

*Work Permit Application
*Import and Export Permit and License Application
*Food and Drink Business Permit and License Application
*Medical Devise Business Permit and License Application
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