H2i Opportunities | H2i Programs

Expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost.

Date: March 18, 2020 Our file number: 20-104980-839 On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost. COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection. Prior to a product being available on the Canadian market, Health Canada reviews product information to confirm the requirements of the Food and Drugs Act (FDA) and its associated regulations are met. Based on the information provided, the Department assesses the risks and benefits of the product to ensure Canadians have access to products that are safe, effective and of quality. In an effort to facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Department will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products. As there are no existing therapies or vaccines to effectively treat or prevent COVID 19, there is an urgent need to get novel therapies into clinical trials. This will allow research in Canada of these novel therapies and provide Canadians access to new investigational therapies aimed at preventing or treating COVID-19. Clinical trials ensure the gathering of information to support the safety and efficacy of the product while allowing access under controlled circumstances. When such trials have sufficient evidence to support full market authorization, Health Canada will work with sponsors to expedite the development and authorization of these products. When expediting the review of submissions and applications with the goal of enabling timely access to vaccines and therapeutic products, Health Canada will continue to ensure products are supported by sufficient evidence of safety, efficacy and quality to merit access to Canadians. Until a vaccine or therapeutic product is available on the Canadian market, Health Canada's Special Access Programs for Drugs and Medical Devices are available to practitioners or healthcare professionals requiring access to drugs that provide supportive treatments to the infection, or diagnostic devices to identify COVID-19 in patients. Sponsors wishing to file a submission or application should contact the appropriate review bureau.

Review Bureau Contact Information:

Biologic and Radiopharmaceutical Drugs Directorate

Office of Regulatory Affairs Tel: 613-957-1722 Fax: 613-946-9520 E-mail: hc.brdd.ora.sc@canada.ca

Therapeutic Products Directorate:

Bureau of Gastroenterology, Infection and Viral Diseases Telephone: 613-941-2566 Fax: 613-941-1183 E-mail: hc.bgivd.enquiries.sc@canada.ca Submission Management Division, Office of Clinical Trials Fax: 613-946-7996 E-mail: hc.oct_bec_enquiries.sc@canada.ca Special Access Programme - drugs Telephone: 613-941-2108 Fax: 613-941-3194 E-mail: hc.sapd-pasm.sc@canada.ca

Natural and Non-prescription Health Products Directorate (NNHPD)

Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division Fax: 613-946-9614 Telephone: 613-946-9315 Telephone: 613-957-6801 for the Regulatory Project Management Unit Email: hc.nnhpd-dpsnso.sc@canada.ca

Medical Device Directorate:

Bureau of Device Licensing Services Email: hc.devicelicensing-homologationinstruments.sc@canada.ca. Investigational Testing Telephone: 613-941-4308 E-mail: hc.it-ee.sc@canada.ca Special Access Program - Medical Devices Tel: 613-946-8711 Fax: 613-957-1596 E-mail: hc.sap.devices.mdb.sc@canada.ca

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Importance: High

Re: MDEL/LEIM bulletin 2020, no. 2 – COVID-19 and your MDEL application

Dear stakeholder:

Health Canada has been working with the Public Health Agency of Canada, as well as with provincial/territorial partners, and international partners to monitor and respond to the evolving situation in support of the COVID-19 pandemic planning efforts.

The purpose of this bulletin is to inform Medical Device Establishment Licence (MDEL) holders of:

1. Steps Health Canada is taking to support the COVID-19 pandemic

2. MDEL applications (New, Amendment and Annual Licence Review)

3. Impact on your operations & medical device shortages

4. Domestic & Foreign Onsite Inspections

1. Steps Health Canada is taking to support the COVID-19 pandemic

In light of the unprecedented demand and immediate need for Personal Protective Equipment (PPE) regarding the COVID-19 pandemic, Health Canada is expediting applications for Medical Device Establishment Licences (MDELs). Health Canada is also exercising enforcement discretion to facilitate expedited and broad access to supplies of medical devices.

In Canada, examples of Class I PPEs can be found, below:

· N95 facepiece respirators

· Gowns

· Masks

· Face shields

· Isolation units, pods or rooms intended for transporting infected and contaminated patients

· Nasal pharyngeal swabs

Class I Products

Health Canada will expedite the review and issuance of MDELs for companies requesting to manufacture, import or distribute Class I PPEs. Health Canada’s goal is to review and issue MDELs within 24 hours from the time a completed application is received.

Companies who need an MDEL application expedited, should do the following:

a) Complete the MDEL Application Form (FRM-0292) available on Health Canada’s website.

b) Email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca.

Please indicate the following in the subject line of your email: *URGENT – COVID-19 – MDEL application for name of company *

Health Canada’s service standard for issuing an MDEL is 120 days, however, it will be expedited to within a 24 hour service standard for this purpose only.

Current MDEL holders importing or distributing non-compliant PPE’s

Whether manufacturing or importing and distributing Class I PPE’s , current MDEL holders seeking to import non-compliant products (e.g., non-bilingual labels) should take the following steps:

a) Complete the attached notification form (“HC Personal Protective Equipment (PPE) – Notification form”)

b) Send the completed form to: hc.mdel.questions.leim.sc@canada.ca

Please include, “COVID – notification NC label” in the subject line of your email to help us prioritize and expedite your request.

2. MDEL applications (New, Amendment and Annual Licence Review)

Health Canada is focusing its efforts on the management of the COVID-19 pandemic, including the processing of MDEL applications for Personal Protective Equipment (PPE) that are medically necessary or that have been deemed as ‘important’ to mitigate the risks associated with the COVID-19 pandemic.

Although this may affect our ability to respond to inquiries regarding your annual licence review or regular MDEL application/amendment, it will not affect Health Canada’s 120-day performance standard to issue all other MDEL application types (new, annual licence review, etc.).

We appreciate your patience as we adjust our operations to manage this situation.

3. Impact on your operations & medical device shortages

In the event that your operations are experiencing challenges that have the potential to affect the supply of critical medical devices as a result of COVID-19 related events, we ask that you:

a) Complete the attached form (“MD Shortage Reporting Form”) for each medical device shortage;

b) Scan the completed form and send it to Health Canada, via hc.meddev-matmed.sc@canada.ca ; and

c) Include “Medical Device Shortage” in the email subject line to ensure it gets adequately prioritized.

4. Domestic & Foreign Onsite Inspections

Effective immediately, Health Canada is postponing all onsite foreign and domestic inspections, indefinitely.

Health Canada’s decision is based on a number of factors, including the Government of Canada’s travel advice and advisories, the Government of Canada’s COVID-19 travel advice, travel restrictions being imposed on foreign visitors by certain countries, as well as the health and safety of our employees.

Health Canada will resume onsite domestic and foreign MDEL inspections, as soon as possible. Health Canada is assessing the possibility of conducting MDEL inspections by means of virtual technologies.

Health Canada remains confident in our ability to maintain oversight over the medical device supply chain and to the MDEL holders. We will continue to ensure the quality of the products and the compliance of MDEL holders, as per the Medical Devices Regulations.

As the situation continues to evolve, Health Canada will consider conducting domestic and foreign inspections on a case-by-case basis. Health Canada will continue to monitor the situation, remain flexible and adapt our approach, as needed, to ensure the health and safety of all Canadians.

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