New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021
Medical Devices Compliance Program Bulletin July 29, 2021
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About IO No. 2
On March 1, 2021, the Minister of Health signed Interim Order No. 2 respecting the importation and sale of medical devices for use in relation to COVID-19 (IO No. 2). This interim order repeals and replaces Interim Order No. 1 (IO No. 1).
IO No. 2 permits Health Canada to continue to issue expedited authorizations for the sale or import of medical devices in order to accelerate access to certain devices during the COVID-19 pandemic.
New requirements under IO No. 2
Regulatory requirements for bilingual labelling
Sections 10 and 11(1-3) of IO No. 2 outline labelling requirements. Labels of IO-authorized devices must be, at a minimum, in either English or French. There are also several additional requirements (for example, bilingual labelling) depending on whether the device is to be sold to the general public. This change takes effect on September 1, 2021.
Further details can be found in the guidance document Applications for medical devices under the interim order for use in relation to COVID-19.
Regulatory requirements for importers and distributors
Under IO No. 1, there was no requirement for importers or distributors of IO-authorized devices to hold a medical device establishment licence (MDEL).
Section 2(2) of IO No. 2 aligns the requirements for importers and distributors of IO-authorized devices to those in the Medical Devices Regulations.
Effective September 1, 2021, importers and distributors of IO-authorized devices must comply with the following sections of the Regulations:
- establishment licence (44 to 51.1)
- distribution records (52 to 56)
- complaint handling (57 to 58)
- incident reporting (59 to 61.1)
- recall (63 to 65.1)
For more information on MDEL requirements, please consult the guidance on medical device establishment licensing and MDEL fees (GUI-0016).
How to submit an MDEL application
Note the service standard to issue a decision is 120 calendar days from the day a complete MDEL application is received.
For questions on the MDEL process, please email us at firstname.lastname@example.org.
For questions on invoicing and fees, please contact the Cost Recovery Invoicing Unit by email at email@example.com.
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