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COVID-19 Product Pathways

 Last Updated: May 22, 2020 at 14h00 (ET) 

 

*NEW* Webinar Recording_COVID-19 Medical Device Authorization: Ventilators / Autorisation des instruments médicaux destinés à être utilisés à l’égard de la COVID-19 : Ventilateurs

Click on the link below to view Medtech Canada’s bilingual webinar event recording: COVID-19 Medical Device Authorization: Ventilators / Autorisation des instruments médicaux destinés à être utilisés à l’égard de la COVID-19 : Ventilateurspresented by Ellie (Eliane) Barras, Senior Regulatory Affairs OfficerMedical Devices Directorate, Health Products and Food Branch & Lisa-Gaye Pryce, Ventilator IO Applications & Senior Scientific Evaluator, General & Restorative Devices Review Division, Medical Devices Directorate, Health Products and Food Branch, Health Canada.Health Canada provides a high-level overview of the various pathways to market access for COVID-19 medical devices. Specific technical requirements for ventilator authorizations are discussed.

During the webinar recording, a correction is noted on slide 10, please find corrected slides below:

IMPORTANT: Pause the event recording to make notes and bookmark applicable links (click on links directly in the presentation displayed in the recording). Health Canada is regularly updating information available online. Please click HERE to subscribe to the Really Simple Syndication (RSS) feed to obtain links to new Medical Devices information when it is posted online. It is highly recommended that you bookmark applicable links for your organization’s application needs and review links regularly, as updated information continues to be added.

 

Webinar Recording _ COVID-19 Medical Device Authorization: in vitro Diagnostic Devices / Autorisation des instruments médicaux destinés à être utilisés à l’égard de la COVID-19: instruments diagnostiques in vitro

Click on the link below to view Medtech Canada’s bilingual webinar event recording: COVID-19 Medical Device Authorization: in vitro Diagnostic Devices / Autorisation des instruments médicaux destinés à être utilisés à l’égard de la COVID-19: instruments diagnostiques in vitro. Health Canada representatives provide a high-level overview of the various pathways to market access for COVID-19 medical in vitro diagnostic devices. Specific technical requirements for diagnostic COVID-19 medical device authorizations were discussed.

Click on the following applicable link to access the important serology based tests guidance document referenced during the presentation.

IMPORTANT: Pause the event recording to make notes and bookmark applicable links (click on links directly in the presentation displayed in the recording). Health Canada is regularly updating information available online. Please click HERE to subscribe to the Really Simple Syndication (RSS) feed to obtain links to new Medical Devices information when it is posted online. It is highly recommended that you bookmark applicable links for your organization’s application needs and review links regularly, as updated information continues to be added.

 

COVID-19 Medical Device Authorization: Personal Protective Equipment Webinar Recording

Click on the applicable link below to view Medtech Canada’s webinar event recording: COVID-19 Medical Device Authorization: Personal Protective Equipment (in English or French). Hear Health Canada representatives explain the pathways to market access developed specifically for COVID-19 medical devices with a focus on personal protective equipment. IMPORTANT: Pause the event recording to make notes and bookmark applicable links (click on links directly in the presentation displayed in the recording). Health Canada is regularly updating information available online. Please click HERE to subscribe to the Really Simple Syndication (RSS) feed to obtain links to new Medical Devices information when it is posted online. It is highly recommended that you bookmark applicable links for your organization’s application needs and review links regularly, as updated information continues to be added.

 

COVID-19 Product Pathways 

There are multiple initiatives surrounding securing the appropriate products to diagnose, treat and prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)‍, also known as COVID-19, in Canada.  This web-page aims to direct readers to the appropriate resources and will be updated as new information is obtained.


Contents (If using Firefox as your browser, click on applicable heading to be redirected. If using Google Chrome, scroll down to applicable section) 


I CAN SUPPLY COVID-19 PRODUCT OR SERVICES

Provide details on the Canada Government website. Ensure you have authorization to import and sell the product as described below.

 

 

I CAN HELP MANUFACTURE COVID-19 PRODUCTS OR NEED FUNDING TO SCALE UP

Canada’s Plan to Mobilize Industry to fight COVID-19 is creating pathways to deploy resources to domestic manufacturers and businesses so they can help during this critical time. Please register on the ISED website. 

 

 

THERE ARE PROVINCIAL OPPORTUNITIES ALSO:

Ontario 

Quebec jecontribue@economie.gouv.qc.ca for non-procurement contributions; for provincial procurement of COVID-19 related products, contact SIGMASANTÉ optechniciensadministratifs@sigmasante.com)

Manitoba 

 

 

I AM SEEKING AUTHORIZATION FOR IMPORTATION OR SALE UNDER THE INTERIM ORDER

The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 provides COVID-19 medical device manufacturers an exemption from the requirements under Part 1 of the Medical Devices Regulationsprovided they have received an authorization for the importation or sale from Health Canada.

When Health Canada determines that there is an urgent public health need for the importation or sale of a COVID-19 medical device, the manufacturer may submit an application for authorization under the Interim Order. If an authorization is granted, the manufacturer may import or sell their COVID-19 device in Canada. The Minister may also decide to issue an expanded indication for use to a device that has either been approved through this Interim Order, or a device that was granted a Medical Device License. The authorization for importation or sale is only valid for so long as the Interim Order is in effect. The Interim Orderwill expire after a one-year period but may be subject to renewal based on the ongoing public health need.

WHAT DOES THIS MEAN?

This Interim Order applies to COVID-19-related Class II-IV devices approved under the Interim Order and exempts companies from requiring a Medical Device Establishment License (MDEL) if they have filed for, and received, authorization.  All importers and Class I manufacturers such as those manufacturing Personal Protection Equipment (PPE) need to obtain a Medical Device Establishment License (MDEL) which is their authorization to import and sell Class I devices.  In all cases, the importer is responsible for the quality of the product imported, reporting mandatory problem reports and medical device shortages.

To submit an application under the Interim Order, review: Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document 

Each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the authorization for importation.

Class II, III and IV devices can also be licenced in accordance with the Medical Devices Regulations. Consult the Medical Devices Active Licence Listing to see whether a Class II, III or IV device is licenced under the Medical Devices Regulations. Diagnostic devices authorized under the Interim order for use against COVID-19 are available in the list of authorized diagnostic devices. The following non-diagnostic medical devices have been authorized for sale or import in Canada under the Interim OrderList of non-diagnostic products authorized under interim order.

If your approved product does not meet all regulatory requirements e.g. bilingual labelling, please review Exceptional importation and sale of medical devices against COVID-19.

 

 

WHY WOULD I CHOOSE AN INTERIM ORDER FOR MY COVID-19 MEDICAL DEVICE?

1. I am a manufacturer of a Class I, II, III or IV medical device

2. I do not currently have the Medical Device Licence / Medical Device Establishment Licence that is required to sell this device in Canada. 

3. I do not have an MDSAP certificate for my ISO 13485 quality system. 

4. There is an urgent public health need for the importation or sale of the device. 

 

 

FEES

There are no fees for COVID-19 related submissions under the Interim Order.

 

 

HOW DO I GET A MEDICAL DEVICE ESTABLISHMENT LICENCE (MDEL)?

Applications to import or distribute Class I-IV medical devices related to COVID-19, or for companies requesting to manufacture, import or distribute Class I medical devices (such as N95 facepiece respirators, gowns, masks, face shields) or nasal pharyngeal swabs in relation to COVID-19, can be submitted for expedited review using the MDEL Application Form (FRM-0292)available on Health Canada’s website. The completed MDEL application form should be sent to:hc.mdel.application.leim.sc@canada.ca, indicating the following in the subject line of the email: *URGENT – COVID-19 – MDEL application for ­[name of company]*.  Authorization will be granted based on an attestation to the requirements. Health Canada is implementing a temporary discretionary measure by assigning MDEL applicants an interim submission number while MDEL applications continue to be processed. A submission number is not an MDEL. It is a temporary number that is being assigned to applicants that have submitted the critical information required to ensure effective oversight of the activity being licensed and will facilitate quicker access to needed products to help combat COVID-19, including at the border. Once applications are fully processed, Health Canada will contact applicants to issue or to refuse to issue an MDEL, at which time, the temporary submission number will no longer be valid. For guidance, review: Guidance 0016 - Medical Device Establishment Licensing and Medical Device Establishment Licensing Fees. For any questions related to the MDEL process, please email hc.mdel.application.leim.sc@canada.ca

 

I QUALIFY FOR SMALL BUSINESS FEE MITIGATION

In light of the COVID-19 pandemic response, please apply for the MDEL first and then you can apply for the small business status.  You can check off Box #7 option 1, that you wish to apply for ‘Small Business Mitigation’. Companies looking to apply for the small business fee mitigation must formally register as a small business on Health Canada’s website, however you can do this after the MDEL has been received. You will be able to use the Company ID that will be assigned to your company when the MDEL is issued as the Unique ID needed for the small business application

 

How Health Canada inspects medical device establishments

These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (Act) and Medical Devices Regulations (Regulations).

 

FIND A MEDICAL DEVICE ESTABLISHMENT LICENCE

To find a Medical Device Establishment Licence click here.

 

 

 

HOW DO I APPLY FOR A PRODUCT LICENCE under the interim order?

Health Canada has a website dedicated to facilitating approval of COVID-19 products under the Interim Order

This website has specific sections for diagnostic tests, ventilators, hand sanitizers and disinfectants, PPE and other useful links as shown below.  Thoroughly review these sections before reaching out to Health Canada for any clarification.

 

DIAGNOSTIC TESTS

Expedited access, authorization for sale, list of authorized devices, special access, who to contact. Please review the guidance document on how to apply for medical devices under the interim order for use in relation to COVID-19. For guidance related to serological tests applications, please also consult the guidance on requirements for serological antibody tests submitted under the COVID-19 Interim Order – links below.

RELATED LINKS

 

VENTILATORS

Expedited review and access, authorization for sale, who to contact.

RELATED LINKS

 

HARD surface Disinfectants and hand sanitizers (COVID-19)

Expedited access, information for manufacturers, list of authorized products, who to contact. Also includes disinfection claims for COVID-19, distribution to hospital and clinics, alternate sources of active ingredients for disinfectants, compounding information for pharmacists, hand sanitizer packaging and reusing containers as well as a hand sanitizer manufacturing exchange.

All approved hand sanitizer products must meet the necessary requirements under the NHPR. A Site Licence is required to manufacture, package, and/or label an NHP hand sanitizer in Canada.

Product Licence, represented by a Natural Product Number (or NPN), is required to legally distribute (i.e., donate or sell) the product. A Product Licence is required even if donating these products.

If your company is seeking both a Product Licence and a Site Licence, you may apply by only completing the Product Licence Application Form accompanied by a cover letter.

You can find additional information on reporting adverse reactions in the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry.

RELATED LINKS

 

PERSONAL PROTECTIVE EQUIPMENT

Personal protective equipment, including devices such as N95 respirators, gowns, masks, gloves and face shields, are medical devices in Canada and are subject to requirements under the Medical Devices Regulations. This sectioncovers expedited access, authorization for sale, who to contact for masks, medical gown and medical gloves.

Learn more about products and services needed along with related specifications.

PRODUCT TESTING LABORATORIES

Product testing is required to demonstrate that 3D printed final products comply with applicable standards. The following laboratories and certification bodies are accredited by the Standards Council of Canada to test against PPE standards:

PRIVATE LABORATORIES

PRODUCT CERTIFICATION BODIES

In response to the COVID-19 outbreak, the CSA Group has made a selection of relevant standards for the COVID-19 outbreak available for no-fee view access.

RELATED LINKS

 

Mobilizing industry to provide medical supplies

Information for Canadian manufacturers, supply and procurement, scale-up and re-tooling, donations, research and funding. 

 

VACCINES AND TREATMENTS

Clinical trials, investigational testing authorizations, expedited review, special access for drugs, who to contact.

RELATED LINKS

 

 

HOW DO I submit A LICENSE application UNDER THE INTERIM ORDER?

Applications should be made on the IO Request Form.The required supporting information can be submitted electronically, in whatever manner the applicant chooses. Applicants are welcome to use standard document submission guidelines (ie: the ToC format), or to provide a “question and answer” style of application, using the criteria specified in the guidance as headers. Applications should be submitted to the following email address: hc.devicelicensing-homologationinstruments.sc@canada.ca

 

 

HOW LONG WILL IT TAKE TO GET A PRODUCT LICENSE?

Health Canada will be expediting all regulatory submissions related to COVID-19 medical devices. For example, Health Canada is targeting 20 days for Class III devices and 25 days for Class IV devices after receipt of required information.

 

Special Access Programme

Healthcare professionals should contact SAP if they are seeking access to COVID-19 devices not authorized for sale in Canada, where that access is for emergency use or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.

 

Mandatory Reporting of Medical device shortages

On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the Interim Order).

The Interim Order makes it mandatory for manufacturers and importers to report to Health Canada shortages of specified medical devices, their components, accessories, parts or consumable materials, related to COVID-19. The requirements are outlined in the Interim Order. The List of Medical Devices – Notification of Shortages, which is incorporated by reference (IBR) in the Interim Order, is maintained by Health Canada and is regularly updated.

 

What is a medical device shortage?

A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials. It does not include a situation in which a substitute device, component, accessory, or part is available.

There are two types of shortages:

1. Actual, when the current supply can’t meet current demand

2. Anticipated, when the future supply can’t meet projected demand

 

Who needs to report a medical device shortage?

Manufacturers and importers must report shortages that are on the List of Medical Devices – Notification of Shortages, located on Health Canada’s website, by completing the electronic reporting form

To avoid duplicate reporting, a manufacturer may permit a designated importer of a medical device to prepare and submit a shortage report on its behalf. This is permitted only when the information that would have been reported to Health Canada by the manufacturer and importer is identical. Under these circumstances, the manufacturer must submit an authorization form  to Health Canada, via email to hc.meddev-matmed.sc@canada.ca.

 

When does a medical device shortage need to be reported?

Information about a medical device shortage is listed on the List of Medical Devices – Notification of Shortages and must be reported to Health Canada when:

- a manufacturer or importer first becomes aware of a shortage (within 5 calendar days)

- a manufacturer or importer anticipates a shortage (within 5 calendar days)

- updated information about a particular shortage needs to be submitted (within 2 calendar days)

- the manufacturer has determined that the end of the shortage can be reported, as they are able to meet market demand (within 2 calendar days)

 

Posting of medical device shortages

Health Canada posts information concerning all shortages that meet the criteria outlined in the Interim Order on Health Canada’s website page, Medical device shortages: List of shortages. More information on medical device shortage reporting may be found on Health Canada’s website.

 

Summary of Important Contacts:

For inquiries or to submit an Authorization Formplease contact: hc.meddev-matmed.sc@canada.ca

 

Advertising Complaints

How to report, lists of complaints on authorized and un-authorized products

 

importing commercial goods 

Please refer to the following links: 

 

OTHER USEFUL LINKS FROM HEALTH CANADA RELATED TO COVID-19 [DATE PUBLISHED]

RECENT HEALTH PRODUCT RECALLS AND ALERTS 

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Medtech Canada is the national association representing the medical technology industry in Canada. Our association advocates for achieving patient access to leading edge, innovative technology solutions that provide valuable outcomes. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our health care system. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities across the country.



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