Health Canada responds quickly to potential medical device shortages during COVID-19
Medical Devices Compliance Program Bulletin March 26, 2021
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About Interim Order (IO) No. 2
On March 1, 2021, the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (IO No. 2). This interim order repeals and replaces the previous interim order.
IO No. 2 permits the continued exceptional importation and sale of health products that may not fully meet Canadian regulatory requirements under the Food and Drugs Act and its Regulations, but are manufactured to comparable standards. Mandatory shortage reporting of critical medical devices is also required under IO No.2.
Exceptional importation and sale
IO No. 2 modifies Health Canada’s approach to official languages for products that arrive in Canada through exceptional importation.
Under the first interim order, importers were expected to make information on the safe use of the product available in French and English. IO No. 2 makes that regulatory requirement explicit.
Importers with products currently for sale in Canada have 6 months to comply.
COVID-19-related medical devices that are permitted for exceptional importation and sale are identified in our list of designated medical devices. Devices approved under the first interim order will continue to be listed here as well. Health Canada updates the list regularly.
How to import and sell designated medical devices
Medical devices governed by the exceptional importation and sale IO may be imported or sold in Canada, provided the importer or Class I manufacturer has a medical device establishment licence (MDEL). To import or sell designated devices, companies must follow a 2-step process.
First, an establishment must submit a request to add a medical device to the list by completing our request form. Health Canada may add a product to the list without receiving a proposal.
The form, French and/or English copies of the labels and applicable certification or testing requirements must be submitted to Health Canada for all of the devices. Submit the completed application form and labels by email to: mailto:email@example.com.
We review all proposals and may contact a company for additional clarification or product-specific information. The type and nature of review depends on a number of factors, such as the type of product and availability of supply.
Second, once a product is on the list, companies must notify us if they wish to import a designated device. They must do so at least 5 business days before the day on which the device is imported.
To notify us, complete the notification form and email it to us at: mailto:firstname.lastname@example.org.
For more information on how to request that a medical device be added to the list for exceptional import and sale, please consult the importation and sale of medical devices for COVID-19 guidance.
Regulatory requirements for selling designated medical devices
During the application of IO No. 2, Canadian establishments may bring designated medical devices into the country without applying all the requirements of the Medical Devices Regulations, except for sections 44 to 65.1. These sections remain in effect even when a medical device is designated on the list.
For more information on MDEL requirements, please consult the guidance on medical device establishment licensing and MDEL fees (GUI-0016).
Reporting medical device shortages
IO No. 2 continues to make it mandatory for manufacturers and importers to report shortages of specified medical devices (or their components, accessories or parts) to Health Canada. The requirements are outlined in IO No. 2.
Specific changes in IO No. 2 from the previous interim order, which was signed by the Minister of Health on March 30, 2020, are as follows:
- clarification that mandatory shortage reporting requirements for substitute devices, components, accessories or parts should be based only on the manufacturer’s own capacity, supply and orders
- clarification that a back-order of less than 30 days does not need to be reported
- update of the timing of reports from calendar to business days
- expanded authority to compel information on medical device shortages
For more information on how to report a medical device shortage, please consult the COVID-19 guidance for reporting medical device shortages (GUI-0137).
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 or parts. It does not include a situation in which the manufacturer is also the manufacturer of a substitute device, component, accessory or part and is able to meet demand for it in Canada.
There are 2 types of shortages:
- actual, when the current supply can’t meet current demand
- anticipated, when the future supply can’t meet projected demand
Who must report a medical device shortage
Manufacturers and importers must report shortages that are on the list of medical devices – notification of shortages by completing our reporting form. Health Canada maintains and updates this list regularly. It’s the responsibility of manufacturers and importers to check it for updates.
Manufacturers and importers are also encouraged to voluntarily report shortages of medical devices not included on the list of specified medical devices when:
- the shortage may cause a patient or user safety issue in Canada
- a compatible substitute medical device, component, accessory or part isn’t available in Canada or can’t be easily replaced
- for example, capital equipment costs, regulatory requirements to validate procedures, lack of compatibility of surgical instruments or with other devices, extensive training
- the shortage is national in scope
To avoid duplicate reporting, a manufacturer may permit a designated importer of a medical device to prepare and submit a shortage report on the manufacturer’s behalf. This is permitted only when the information that would have been reported to us by the manufacturer and importer is identical. Under these circumstances, the importer must submit an authorization form by sending an email to email@example.com.
When a medical device shortage must be reported
Information about a shortage of a medical device listed on the list of medical devices – notification of shortages must be reported to us when a manufacturer or importer:
- first becomes aware of shortage (within 5 business days)
- anticipates a shortage (within 5 business days)
- has updated information about a particular shortage (within 2 business days)
- has determined that the shortage has ended, as they are able to meet demand (within 2 business days)
Posting medical device shortages
Reported shortages that meet the criteria outlined in IO No. 2 are posted on our list of shortages. For more information on medical device shortages and reporting, see our medical device shortages webpage or send an email with your inquiry to firstname.lastname@example.org.
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