Apr 15, 2020

Health Canada (HC) has issued a series of announcements of emergency measures and guidance documents since COVID-19 was declared to be a global pandemic. The agency’s actions that will most directly impact medical device manufacturers (and manufacturers outside the industry who are temporarily producing medical supplies) are detailed below. HC has also published an online COVID-19 resource center, one section of which gathers information for manufacturers and distributors of PPE, medical devices, and IVDs.

Mandatory reporting requirements remain in place during the COVID-19 pandemic

HC issued a notice clarifying expectations regarding mandatory reporting of adverse reactions and incidents during the pandemic. This stated that requirements are still applicable and that the timeline for reporting should be maintained as closely as possible, but that the government body recognizes the potential for unavoidable delays. If such delays occur, medical device manufacturers and responsible parties should report events as soon as possible and document what has been delayed. Incidents associated with COVID-19 should be reported according to the first Interim Order listed below.

Interim Order establishes expedited route for COVID-19 medical devices

On March 18, HC published Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which provides an expedited route for imported COVID-19 related medical devises so as to ensure timely access to novel therapies against COVID-19 without compromising the safety, efficacy, and quality of products. This process exempts medical devices from the provisions of Part 1 of the Canadian Medical Devices Regulations and removes other obstacles such as application fees and the requirement of an MDSAP certificate. 

This Interim Order was supplemented with a guidance document explaining its scope; its requirements for authorization, labelling, and incident reporting; and the expanded use and recall provisions that it contains.

Learn how other device markets are responding to COVID-19.

New guidance documents address supply of medical gloves, gowns, face masks, and respirators

HC published one guidance document on regulatory considerations for the supply of disposable medical gloves during the COVID-19 pandemic, and another for the supply of medical gowns. The documents cover topics such as: fast-track approval, labelling considerations, information to current MDEL holders seeking to import/distribute medical gloves or gowns with non-compliant labelling, HC and WHO standards, and risk prevention.

A third guidance document comments on the use and supply of face masks and respirators during the pandemic. It discusses a new fast-track approval route created to import non-compliant masks in order to boost their supply. The document also covers best practices for using masks and respirators, especially those that have gone beyond their shelf life.

Use of US FDA guidance for importation and sale of ventilators

HC issued a notice encouraging manufacturers and distributors to reference a US FDA guidance dealing with enforcement policy for ventilators during the COVID-19 pandemic, in addition to HC’s required review elements, when compiling submissions. This document states that the US FDA will temporarily permit limited modifications to the indications, claims, and functionality of ventilators, as well as modifications to the hardware, software, or materials of FDA-cleared devices, without prior submission of a premarket notification. It is hoped that this will allow for more flexibility for manufacturers making device modifications to address current manufacturing limitations or supply shortages.

Second Interim Order Targets Device Shortages

On March 30, HC published Interim Order Respecting Drugs, Medical Devices, and Foods for Special Dietary Purpose in Relation to COVID-19. This requires manufacturers and importers of essential COVID-19 related devices to report any shortages of such devices within five of becoming aware of or anticipating the shortage. Additionally, the manufacturer or importer must notify the Minister within two days once they are able to meet the demand for the medical device. The Interim Order provides a list of all the information that must be submitted when reporting a shortage.

To accompany this Interim Order, HC created a Medical Device Shortages overview page which summarizes reporting timelines and the general process for reporting shortages, along with other information.

Other documents explain N95 respirator reprocessing and Private Label license applications

HC issued a notice highlighting two separate reprocessing strategies for single-use N95 respirators. The first strategy applies to sterilization devices that are manufactured and sold to reprocess N95 respirators. The second strategy applies to companies that reprocess and distribute N95 respirators to healthcare facilities.

HC also published a new revision of the guidance document, How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device. The updates reflect the new guidance document, Fees for the Review of Medical Device License Applications. Private Label medical devices are exempt from review fees associated with license applications and license amendment applications.

Related Health Canada medical device regulatory information from Emergo by UL:

  • Health Canada Medical Device License (MDL) registration consulting
  • Canadian medical device classification consulting
  • CMDCAS, MDSAP, and Health Canada ISO 13485 quality compliance support
  • Regulatory process chart: Health Canada approval for medical devices

 

Author

  • Timothy Herr

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