S'inscrire   |   Nous joindre   |   Imprimer la page   |   Se connecter
COVID-19-Filières de produits

 Last Updated: January 2021


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 

 

MOBILIZING INDUSTRY TO PROVIDE MEDICAL SUPPLIES

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

 

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 Regulations provided 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 Order will 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. Devices authorized under the Interim order for use against COVID-19 are available in the list of authorized devices.

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. 

 

What happens when the interim order ends? 

The current IO expires on March 18, 2021. However, Health Canada intends to introduce a second interim order to maintain the flexibilities and regulatory oversight provided by the current IO until at least the fall of 2021. 

To allow COVID-19 devices authorized under the IO to continue to be imported and sold, Health Canada is also developing transition regulations so that people can continue to have access to the COVID-19 medical devices they need. 

These proposed transition regulations would take effect when the second interim order ends in the fall of 2021 and would remain in place for 2 years. During this time, manufacturers, importers and distributors would have an opportunity to transition from a COVID-19 IO authorization to a regular medical device licence or a Medical Device Establishment Licence (MDEL). 

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/transition-regulations-interim-order-notice.html

 

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. 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 testing devices, 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.

 

Authorized medical devices for uses related to COVID-19: Overview

Expedited access, authorization for sale, list of authorized devices, special access, who to contact.

RELATED LINKS

 

Testing Devices

Types of tests, serological tests, list of  applications under evaluation. 

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

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 .

Related Links 

 

TESTING LABORATORIES

Product testing is required to demonstrate that 3D printed final products and PPE comply with applicable standards. For an up to date list of laboratories and certification bodies that are accredited by the Standards Council of Canada to test against PPE standards, please see Standardization Network Response to COVID-19

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

 

Providing Medical Supplies 

Information for Canadian manufacturers, who to contact. 

 

Border requirements for importing and exporting health products (COVID-19)

 

VACCINES AND TREATMENTS

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

RELATED LINKS

 

HOW DO I file for A LICENSE 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 

 

Webinar Recordings 

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 : Ventilateurs presented by Ellie (Eliane) Barras, Senior Regulatory Affairs Officer Medical 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.

Lors de l’enregistrement du webinaire, une correction est notée sur la diapositive 10, veuillez trouver les diapositives corrigées ci-dessous :

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.

 

Enregistrement du webinaire _ 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.

Cliquez sur le lien applicable suivant pour accéder à l’important document d’orientation sur les tests sérologiques auquel il est fait référence lors de la présentation.

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 Autorisation des instruments médicaux : Enregistrement du webinaire sur les équipements de protection individuelle

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.

Recherche
Accès membre


 

 

Medtech Canada est l’association nationale représentant le secteur des technologies médicales au Canada. Notre association plaide pour un accès à des solutions technologiques novatrices pour les patients en améliorant leur sort. Nos membres s’engagent à fournir des technologies médicales sécuritaires et novatrices qui améliorent la qualité des soins aux patients et permettent la durabilité de notre système de soins de santé. Le secteur des technologies médicales au Canada emploie plus de 35,000 Canadiens dans environ 1 500 établissements de part et d’autre du pays.



Bureau de Toronto

900-405 The West Mall
Toronto, ON M9C 5J1
416.620.1915
1.866.586.3332
 

Bureau du Québec

204, Notre-Dame O.  Bureau 402
Montréal, Québec H2Y 1T3

(514) 217-1167