Health Canada Notice of 18 March 2020: Free Expedited Review for COVID-19 Health Product Submissions

Summary

On 18 March 2020, Health Canada issued a notice announcing that submissions for medical devices and related health products intended for the diagnosis, treatment, mitigation or prevention of COVID-19 would be subject to a free, expedited review, in order to accelerate access to the Canadian market. The notice also sets out the treatment of clinical trials, the Special Access Program and the contact channels for reviews. For Chinese medical device manufacturers planning to export to Canada, the notice has direct implications for registration strategy, technical documentation and post-market surveillance.

Source and Scope

Source: Health Canada Medical Devices Announcements. Reference: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-expediated-review-health-products-covid-19.html. This article is a translated and adapted summary of publicly available information from Health Canada Medical Devices Announcements. Specific requirements remain subject to the regulator's latest official publications.

Full Translation of the Original Notice

On 22 February 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These regulations accelerated access to COVID-19 medical devices for which there is an urgent public health need in Canada, and allowed COVID-19 medical devices authorized under the Interim Order to continue to be imported and sold. For further information, refer to the notice on amending the Medical Devices Regulations to continue the importation and sale of COVID-19 medical devices, and to the guidance on COVID-19-related medical devices.

Date: 18 March 2020
Document number: 20-104980-839

On 18 March 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 facilitate a free, expedited review of medical devices intended for the diagnosis, treatment, mitigation or prevention of COVID-19.

COVID-19 is a new disease that had not previously been identified in humans. There are currently no authorized COVID-19 vaccines or therapeutic products for the treatment or prevention of the disease. The COVID-19 outbreak has prompted a global review of therapies that may be used to treat or prevent the infection.

Before a product enters the Canadian market, Health Canada reviews the product information to confirm that it complies with the requirements of the Food and Drugs Act and its associated regulations. On the basis of the information provided, the Department assesses the risks and benefits of the product to help ensure that Canadians have access to safe, effective and high-quality products.

To facilitate earlier access to COVID-19 vaccines or therapeutic products, the Department will expedite the review of any health product submission or application related to COVID-19. This will help ensure timely access to new therapies without compromising product safety, efficacy and quality.

Because there are currently no existing therapies or vaccines that effectively treat or prevent COVID-19, there is an urgent need to bring new therapies into clinical trials. This will allow Canada to conduct research on these new therapies and to offer Canadians new investigational therapies intended to prevent or treat COVID-19. Clinical trials make it possible to collect information supporting a product's safety and efficacy while providing access to drugs under controlled conditions. Once such trials generate sufficient evidence to support full market authorization, Health Canada will work with sponsors to expedite the development and authorization of these products. While expediting the review of submissions and applications to enable timely access to vaccines and therapeutic products, Health Canada will continue to ensure that products are supported by sufficient evidence of safety, efficacy and quality to warrant their availability to Canadians.

Before a vaccine or therapeutic product is available on the Canadian market, Health Canada's Special Access Program for drugs and medical devices remains available to practitioners or health care professionals who need access to supportive therapeutic drugs or to diagnostic devices to identify COVID-19 in patients.

Sponsors wishing to file a submission or application should contact the relevant review bureau.

Review bureau contact information

• Biologics and Radiopharmaceuticals Directorate, Regulatory Affairs Office: Tel 613-957-1722; Fax 613-946-9520; Email hc.brdd.ora.sc@canada.ca
• Therapeutic Products Directorate, Gastrointestinal, Infection and Viral Diseases Bureau: Tel 613-941-2566; Fax 613-941-1183; Email hc.bgivd.enquiries.sc@canada.ca
• Office of Clinical Trials, Submission Management Division: Fax 613-946-7996; Email hc.oct_bec_enquiries.sc@canada.ca
• Special Access Program for Drugs: Tel 613-941-2108; Fax 613-941-3194; Email hc.sapd-pasm.sc@canada.ca
• Natural and Non-prescription Health Products Directorate (NNHPD), Non-prescription Drug Evaluation Division, Regulatory Project Management Unit: Fax 613-946-9614; Tel 613-946-9315; Regulatory Project Management Unit Tel 613-957-6801; Email nnhpd.consultation-dpsnso@hc-sc.gc.ca
• Medical Devices Bureau, Device Licensing Services Division: Email devicelicensing-homologationinstruments@hc-sc.gc.ca
• Investigational Testing: Tel 613-941-4308; Email it-ee@hc-sc.gc.ca
• Medical Devices Special Access Program: Tel 613-946-8711; Fax 613-957-1596; Email sap.devices.mdb@hc-sc.gc.ca

AIMEILI Regulatory Interpretation and Business Impact

What this information means for medical device companies

When an update such as this is published under Health Canada Medical Devices Announcements, companies should first determine whether it concerns regulatory policy, guidance or standards, recalls and safety, product performance, quality systems, or post-market oversight. Each category affects the registration pathway, technical file, labels and instructions for use, risk management and market maintenance differently, and it should not be treated merely as general industry news.

For Chinese medical device manufacturers, the key task is to convert the news into executable compliance actions: confirm whether comparable products, comparable technology routes or comparable risk points are involved; verify that existing documentation still supports the requirements of the target market; and where necessary, update risk management, performance verification, clinical evaluation, labels and instructions for use, distributor communications and post-market surveillance records.

Which documents should be reviewed first?

Priority should be given to the intended use of the product, the basis for classification, ISO 13485 quality system evidence, the risk management file, performance verification data, clinical evaluation or clinical evidence, labels and instructions for use, authorization documents and existing registration certificates.

Common risks

Common risks include unclear classification decisions, an incomplete evidence chain, labels and instructions for use that have not been localized, unclear responsibilities of the authorized representative, and inadequate post-market maintenance arrangements.

AIMEILI perspective on the registration pathway

Although the notice published by Health Canada was a temporary measure introduced during the 2020 pandemic, the page was still being updated in 2023, which shows that the expedited review channel for COVID-19-related medical devices has continued to evolve. For Chinese medical device manufacturers intending to enter the Canadian market, three key points should be noted. First, Canada does have an accelerated review mechanism for situations of urgent public health need, but that mechanism is not static, and companies must verify the regulations and orders currently in force. Second, even under expedited review, the requirements for safety, efficacy and quality are not lowered, and a complete technical file is still required. Third, establishing effective communication with a Canadian local agent and with the regulator is essential.

From a registration pathway perspective, the 2020 Interim Order established the free expedited review, while the amending Regulations introduced on 22 February 2023 carried the Interim Order forward. This means companies can no longer simply rely on the earlier policy and must re-map the registration pathway against the amended regulations. For pandemic-related products such as diagnostic devices, ventilators and protective equipment, sponsors should assess whether the standard pre-market review applies or whether the fast-track channel continued after the Interim Order applies, and should confirm the applicable conditions directly with Health Canada.

Classification and technical documentation

The Interim Order did not relax classification principles or technical review requirements. Companies must continue to classify their products correctly under the Canadian Medical Devices Regulations and prepare a complete technical dossier covering the risk management file, performance verification reports, clinical evaluation data, labels and instructions for use. For in vitro diagnostic devices, clinical performance evaluation is particularly important, and sufficient sample data must be collected in accordance with ethical requirements to support the intended use.

Clinical evaluation and post-market surveillance

From a clinical evaluation and post-market surveillance perspective, the notice places particular emphasis on bringing new therapies into clinical trials, which indicates that for high-risk or novel products, conducting clinical trials in Canada may be a prerequisite for obtaining market authorization. Companies should plan their clinical evaluation strategy in advance and use routes such as the Canadian Special Access Program to accumulate real-world data. After approval, companies must also fulfil post-market surveillance, adverse event reporting and recall obligations, and adjust technical files and labels in a timely manner as regulations are updated, so as to maintain continuous compliance.

Implications for Chinese manufacturers

For Chinese companies, the lesson from this notice is that entering the North American medical device market cannot rely on compressed timelines alone; it requires standing capabilities covering regulatory intelligence, technical documentation and quality management systems. Companies are advised to engage consultants familiar with Canadian regulations at the project initiation stage, to determine product classification and the submission pathway accurately, and to embed ISO 13485 requirements into design and development so that a first-time pass can still be achieved under expedited review, while also laying the foundation for subsequent post-market oversight.

FAQ

Can the Health Canada notice of 18 March 2020 on expedited review of COVID-19 health product submissions be used directly as a basis for filing?

No. This article is intended for preliminary understanding and project assessment. A formal submission must still be based on the latest requirements of the target country's regulator, the concluded product classification and the company's actual documentation.

What should companies do first after seeing an update of this kind?

Companies should first carry out a documentation gap assessment to confirm whether the update affects the registration pathway, technical file, labels, quality system or post-market maintenance. The assessment should identify whether comparable products or technology routes are affected and whether any corrective action is required before the next submission or market maintenance cycle.

Review and Applicability Notes

Content author: AIMEILI Regulatory Editorial Team
Professional review: AIMEILI International Medical Device Registration Project Team
Source principle: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.
Scope of application: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulator, testing conclusions or legal advice.