Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order

Date Published: March 25, 2020
Updated: April 21, 2020

On this page

• Background
• Use of US FDA guidance
• Interim order submission pathway information
• Ventilator review elements
• Feedback

Background

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 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.

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.

Use of US FDA guidance

The United States Food and Drug Administration (US FDA) released a guidance document in March 2020 to help expand the availability of ventilators and other respiratory devices and their accessories during the pandemic. As per Health Canada’s position on the use of US FDA guidance, stakeholders are encouraged to reference the US FDA’s guidance in addition to Health Canada’s required review elements when compiling their submission to Health Canada.

Interim order submission pathway information

The Interim Order allows for the expedited review of COVID-19 medical devices. Manufacturers wishing to submit an application for authorization for importation or sale should submit their application form and supporting evidence, in the case of Class III or IV devices, to devicelicensing-homologationinstruments@hc-sc.gc.ca. Applications will undergo a screening process to ensure all information is included before being reviewed. Applicants should note that Health Canada may impose or amend terms and conditions at any time during the authorization period.

Applicants must complete the application form. They are also encouraged to consult the Health Canada guidance on COVID-19 medical devices here. Applicants are encouraged to use the Table of Contents format to structure their supporting evidence, however Health Canada will accept submissions in any format the applicant chooses to use.

Ventilator review elements

Health Canada's requirements are in line with the US FDA's March 27, 2020, update announcing their issuance of an Emergency Use Authorization for ventilators and their accessories such as connectors and splitters.

Health Canada will conduct an expedited review for Class III or IV COVID-19 medical devices filed under the Interim Order. In the case of mechanical ventilators, the following specific evidence and technical considerations should be provided, in accordance with section 4 of the Interim Order:

1. A device description should be provided in accordance with section 4(1)(a), and should include critical ventilator parameters, specifications, and ranges. 

2. A design philosophy should be provided in accordance with section 4(1)(a), and should include a tabular comparative chart illustrating the similarities and differences between the subject ventilator and any other similar licenced ventilators in Canada or other countries.
3. Labelling documents including packaging/product labels, package inserts, Instructions for Use (IFU), and user manuals (physician, patient) should be provided in accordance with section 4(1)(j), and should specify the patient population (i.e. adults, children) in the indications/intended use statement in accordance with section 4(1)(f).  The directions/instructions for use of the device are required in accordance with section 4(1)(h). Manufacturers can also provide extra levels of labelling or statements regarding COVID-19 reprocessing procedures (i.e. cleaning and disinfection instructions), including the filters utilized in their IFU and/or Owner’s Manuals.
4. A marketing history in accordance with section 4(2)(b), for the proposed ventilator and/or similar licensed comparator device, including the number of units sold, and any reported complaints/adverse events or recalls and implemented corrective measures, by country.

5. A Declaration of Conformity (DOC) to Health Canada recognized standards, or a list of standards used in the design, manufacture, and evaluation of the device in accordance with section 4(1)(g). Health Canada recognized standards applicable to ventilators that may be referenced include:

   • IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
   • IEC 60601-1-2: 2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
   • IEC 60601-1-6: 2013-Ed.3.1: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
   • IEC 62366-1: 2014: Medical devices – Application of usability engineering to medical devices       
   • IEC 60601-1-8: 2006+A1:2012: Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
   • CAN/CSA-C22.2: 2005+A1:2012:  No. 60601-1:08 is included as a part of the CB certificate and test report.               
   • IEC 62304: 2006 +A1:2015: Medical device software – Software life-cycle processes
   • ISO 10993-1: 2009: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
   • ISO 80601-2-12:2011: Medical electrical equipment – Part 2-12 Particular requirements for the safety of lung ventilators – Critical care ventilators.
   • ISO 80601-2-55:2011: Medical electrical equipment – Part 2-55 Particular requirements for the safety – Respiratory gas monitors
   • ISO 80601-2-61:2011: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
   • ISO 80601-2-72: 2015: Medical electrical equipment – Part 2-72 Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients.
   • EN 13544-1: 2007+ A1:2009: Respiratory therapy equipment – Part 1: Nebulizing Systems and their components     
   • ISO 17664: 2004: Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
   • ISO 14971: 2007: Medical devices – Application of risk management to medical devices  
   • ISO 13485: 2016: Medical devices – Quality management systems - Requirements for regulatory purposes               
   • EN 1041: 2008 + A1:2013: Information supplied by the manufacturer of medical devices
   • ISO 15223-1:2016: Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements

   This list of standards is not exclusive. Additional standards not included in this list may be used to support safety and effectiveness the device, including:

   • ISO 18562-1 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 1: Evaluation and Testing Within a Risk Management Process
   • ISO 10651-5 First Edition 2006-02-01: Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
   • ISO 80601-2-74 First Edition 2017-05: Medical Electrical Equipment - Part 2-74: Particular Requirements for Basic Safety and Essential Performance of Respiratory Humidifying Equipment

   Test summaries including the description of the test method, test articles, acceptance criteria, results and discussion must be provided to justify the relevancy of the standards.

6. A summary of bench testing used to support the electrical/electromechanical specifications and functionality of the device in accordance with section 4(1)(g), particularly if the ventilator does not utilize a software program. The following bench/electrical/mechanical testing is required to demonstrate performance:

   1. Electrical Safety & Electromagnetic Compatibility
   2. Environmental Verification
   3. Ventilator Performance
   4. Gas Monitor Performance
   5. Design Verification and Validation
   6. Usability

   This list of testing is not exclusive. Additional comprehensive testing can be provided to support the functionality, safety, and effectiveness of the medical device. Test summaries provided must include description of the test methods, test articles, acceptance criteria, results, and discussion.

7. A summary of software verification and validation for the release version in accordance with section 4(1)(g).  The following evidence is required to verify the software functionality: 

   1. Software Name
   2. Release Version
   3. Software Description
   4. Device Hazard Analysis
   5. Traceability Analysis
   6. Software Development Environment
   7. Summary of  Software Functionality Verification and Validation Testing with Case Studies
   8. Cybersecurity (if applicable)
   9. Revision Level History
   10. Unresolved Anomalies

   Test summaries provided must include description of the test method, test articles, acceptance criteria, results and discussion.

8. A summary of clinical evidence, including clinical study results and/or literature review, in accordance with section 4(1)(g) if and only if the ventilator includes novel features and concepts. Otherwise, the ventilator is an established technology and clinical study data is not required.

9. Ventilators are provided non-sterile, however reprocessing procedures (i.e. cleaning, disinfection) for the ventilators utilized on COVID-19 patients and adequate validation of these instructions should be provided in accordance with section 4(1)(g).  The type of inspiratory/expiratory filters used including validation of the filters to demonstrate the prevention of COVID-19 transmission through contamination of the internal components of the ventilator is required. If a ventilator becomes contaminated, the mitigation steps and instructions required to reprocess the internal components of the vent. This information should be included in the labelling in accordance with section 4(1)(h).

   This list highlights the specific technical and scientific information required for a ventilator medical device. Applicants should ensure that they comply with the requirements of the Interim Order and guidance document on COVID-19 medical devices for additional pertinent evidence to be provided.

Feedback

Please direct any questions or comments regarding this notice to the following:

Medical Devices Directorate
meddevices-instrumentsmed@hc-sc.gc.ca