Health Canada is conducting consultations with industry that import COVID-19 Medical Devices, your submission deadline is January 15, 2021. Health Canada wish to inform you about a proposed new interim order that Health Canada is developing and to seek your feedback on proposed transition regulations.
The Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19 (the IO) is set to expire in March 2021. With the COVID-19 pandemic still ongoing, Health Canada is proposing a second interim order to maintain the flexibilities and regulatory oversight provided by the current IO until at least fall 2021.
Health Canada is also developing transition regulations that are anticipated to take effect after the expiry or repeal of the second interim order. The proposed transition regulations would permit the continued importation and sale of authorized devices during the transition period while the manufacturer is seeking a regular medical device licence or Medical Device Establishment Licence (MDEL). The regular medical device licence or MDEL would enable these devices to stay on the market after the expiry of the proposed transition regulations.
Attached is a questionnaire on costs and benefits as well as a policy document (Annex A) that describes in detail the proposed second interim order provisions and transition regulations. Your responses will be carefully considered and will help to inform our approach. They can also help us to adjust our policies to minimize costs. While we welcome qualitative description in your responses, quantitative data would be most helpful in supporting our analysis.
Also attached is a letter for small-to medium-sized medical device manufacturers that provides a high-level overview of the proposed changes.
We ask that you please submit your responses to the consultation questions, as well as any other comments and questions that you may have about the transition regulations, to: hc.lrm.consultations-mlr.sc@canada.ca no later than January 15, 2021.
Please note that, in the coming weeks, a webinar is being hosted by Health Canada in your official language of choice. During the webinar, we will discuss the proposed second interim order and proposed transition regulations in further detail, and you will have an opportunity to ask questions.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada | hc.lrm.consultations-mlr.sc@canada.ca
Learn more on the New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19):