The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products. The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The second new order extends and updates the Minister’s authority to permit the import and sale of foreign drugs, medical devices, and foods for a special dietary purpose to alleviate domestic shortages of those products.
The new IOs will expire on March 1, 2022, unless they are repealed or superseded by regulations.
A complete list of the interim orders issued pursuant to s. 30.1(1) of the Food and Drugs Act since the start of the pandemic, with links to our posts on them, are found at the bottom of this post.
Summary of changes: Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
This IO (IO #7 in the list below) repeals and replaces IO No. 1 of the same name (IO #1 in the list below), which provided a streamlined process to authorize the importation or sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19, as of March 1, 2021. The new IO allows COVID-19 devices authorized under IO #1 to continue to be imported and sold without further action from the manufacturer.
Authorizations granted under IO #1 are considered as authorizations under the IO #7 and any terms and conditions attached to the initial authorization continue to apply. Any applications underway under IO #1 will continue to be processed as an application under the IO #7 without further action from the manufacturer.
IO #7 also introduces a requirement that importers and distributors of medical devices hold a medical device establishment licence in accordance with the Medical Device Regulations, as well as a requirement that manufacturers, importers, and distributors comply with bilingual labelling requirements. Both changes are subject to a six-month transition period for authorizations granted under IO #1.
Health Canada anticipates that transition regulations, which we previously reported on, will be introduced in fall of 2021 to convert authorizations granted under the new IO into an active medical device licence for Class II, III and IV devices. Health Canada plans to continue authorizations for Class I devices for an additional 18 months after the coming into effect of the transition regulations. After that, the standard requirements of selling through a medical device establishment licence holder will apply.
More information on IO #7 can be found in Health Canada’s notice and in the Canada Gazette publication. More information on the anticipated transition regulations can be found here.
Summary of changes: Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19
This IO (IO #8 in the list below) repeals and replaces IO No. 1 of the same name (IO #2 in the list below), which was issued to alleviate shortages of certain medical devices, drugs and foods that arose in the early days of the pandemic by permitting importation of foreign health products that may not have fully met Canadian regulatory requirements but were otherwise manufactured to comparable standards. As of February 17, 2021, 56 drugs, 265 medical devices and 2 foods for a special dietary purpose were permitted for exceptional importation and sale under IO #2.
IO #2 also introduced the mandatory reporting of medical devices, which is not currently required under the standard regulatory regime.
IO #8 extends and updates these authorities, including the following changes:
Updates regarding the import and sale of foreign health products
IO #8 formally incorporates the Minister’s ability to authorize disinfectants and drug-based hand sanitizers for exceptional importation. These products had previously been handled through an internal policy, which exempted foreign products from certain requirements under the Food and Drug Regulations, rather than a formal interim order.
The import and sale of drug-based hand sanitizers (e.g., antibacterial wipes) will now require a drug establishment licence, which was not required under the previous policy, subject to a six-month grace period for existing exemptions.
IO #8 also formalizes certain labeling requirements for these products, including the requirement that product information be available to consumers in both English and French, subject to a six-month grace period for existing exemptions.
New Ministerial authority to compel information for medical device shortages
IO #8 clarifies that a manufacturer is only required to report its own shortages, and only where those shortages are expected to last greater than 30 days. These changes are more closely aligned with shortage reporting requirements of the U.S. Food and Drug Administration.
IO #8 also introduces an expanded authority for the Minister to request information on existing and potential medical device shortages that have not been reported or that are not subject to an obligation to report. The Minister can request this information from any manufacturer, importer or distributor of a medical device if she has reasonable grounds to believe that there is a shortage or risk of shortage of the medical device (e.g., media reports, provincial government reports), the information is necessary to prevent or alleviate the shortage, and the person would not have provided the information unless legally compelled to do so.
More information on IO #8 can be found in the Canada Gazette publication.
List of interim orders issued during COVID-19
Here is a list of the interim orders issued by the Minister of Health since the beginning of the pandemic. All interim orders are set to expire 1 year after the date they were initially signed.
- Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020; repealed and replaced by IO #7) (IO #1)
- Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (signed March 30, 2020; repealed and replaced by IO #8) (IO #2)
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (signed May 23, 2020)
- Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (signed September 16, 2020)
- Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 (signed October 16, 2020)
- Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (signed November 27, 2020)
- Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 1, 2021) (IO #7)
- Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (signed March 1, 2021) (IO #8)