Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is showing the understanding from Health Canada that stakeholders require predictability for applicable regulatory aspects in respect to the interim orders.
The notice will be updated with links to notices regarding any consultations, and any related measures, as they are occurring/released.
The following outlines key information and updates that were delivered through this notice.
- The flexibilities and regulatory oversight that has been provided through the use of these IOs will be maintained until at least the fall of 2021.
- After the fall of 2021, regulatory amendments will be introduced that will allow for many of these temporary flexibilities to continue.
- In the coming months, interested industry stakeholders, health system partners and other government departments will be consulted by Health Canada on the proposed regulations.
Interim Orders (IOs)
An IO is one of the fastest options for change available to the federal government to help make health products available to address larger-scale public health emergencies.
The objective of the Interim Orders is to expedite any necessary authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs.
It allows for Medical Device Establishment Licences to be issued in relation to COVID-19 drugs in a manner that ensures pandemic related medical supplies remain accessible to all Canadians.
These Interim Orders further provide the Chief Public Health Officer of PHAC the ability to notify the Minister of a need to pre-position a promising COVID-19 drug in Canada. In order for a drug to be pre-positioned, the Government of Canada must have entered into a contract for its procurement and the manufacturer must have filed an application for the drug’s authorization in Canada, or abroad with a foreign reference regulator. Together, these measures help ensure Canadians have timely access to COVID-19 drugs.
A total of 5 interim orders have been issued in response to the COVID-19 pandemic since March 2020. These IOs have focused on making changes necessary to ensure that necessary Medical Device Licenses can be issued quicker in response to the current pandemic while also ensuring that the products and licenses continue to have sufficient oversight.
The following will summarize some important information from the currently issued IOs.
Importation and Sale of Medical Devices
Part 1 of the Regulations, with the exception of sections 52 to 56 and 63 to 65.1, no longer apply to the importation or sale of a COVID-19 medical device if the following conditions are met:
- the Minister determines that there is an urgent public health need for the importation or sale of the device;
- the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
- the Minister has issued the authorization; and
- the authorization has not been cancelled.
All shipments of COVID-19 medical devices that are imported in Canada must be accompanied by a copy of the proper authorization for importation.
Permitting Exceptional Importation of Key Products
If a shortage of a specified medical device — or of its components, accessories, parts or consumable materials — has been reported or is likely to occur, the manufacturer and the importer of the device must each submit the following information to the Minister in both English and French in the form and manner determined by the Minister:
(a) the name and contact information of the manufacturer and of the importer;
(b) in the case of a Class II, III or IV device, the medical device licence number;
(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d) the name of the device and of any component or accessory of the device, including, if applicable, the model name;
(e) a description of the device;
(f) the date when the shortage began or is anticipated to begin; and
(g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated.
This information must be submitted within 5 days after the manufacturer or importer becomes aware of a shortage. This also applies to any anticipated shortages
If any information previously submitted by the manufacturer or importer changes, the new information must be submitted to the Minister within 2 days after the change is made or 2 days after becoming aware of the change.
Once the shortage has been resolved and the manufacturer is once again able to meet the full demand for the medical device – or for its components, accessories, consumable material or parts – the manufacturer or importer will have 2 days to notify the Minister in writing to that effect.
Specified medical devices involved in the COVID-19 interim measures can be located on the Health Canada website within the COVID-19 Health Product Industry page. (https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html)
Prevention and Alleviation of Drug Shortages
As previously noted, the COVID-19 pandemic has caused an unprecedented demand for certain drugs and medical devices. As such, an interim order was issued in order to properly manage the subsequent drug shortages.
Under certain conditions;
- Anyone who sells a drug may now be required to provide information that is relevant to a (potential) shortage of that drug relating to COVID-19.
- The Minister of Health may also impose or amend terms and conditions placed on authorizations for selling drugs.
This Interim Order will assist with trending the usage of certain drugs in order to ensure all Canadians have uninterrupted access to the necessary COVID-19 related drugs.
How we can help
Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Cannabis, Pharmaceutical, Natural Health Product, Food and Medical Device industries