Health Canada, the department of the Government of Canada responsible for national health policy, last 21st November issued a reminder for Medical Devices manufacturers to remind them of the need to comply with the regulatory requirements set out in the Summary Reports regulations in the Food and Drugs Act effective from 23rd December 2021.
For Class II Medical Devices, it is necessary for manufacturers to prepare the Summary Report for each Medical Device Licence (MDL) obtained by 23rd December 2023, while for Class III and IV Medical Devices, the deadline is 23rd December 2022.
The guidance document Guidance on summary reports and issue-related analyses for Medical Devices has been purposely published to better understand and prepare documentation in accordance with Sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations.
The requirements on Summary Reports do not apply to Class I devices.
Timelines
After the initial submission, Summary Reports must be submitted to Health Canada at periodic intervals, including a critical and concise analysis of the information received on the use of authorised devices and an indication of whether there have been any changes in the associated device’s risks/benefits. In the latter case, Health Canada must be informed in writing within 72 hours.
Periodic submission intervals are:
- for Class II MDLs: every 2 years with information collected in the previous 24 months;
- for Class III and IV MDLs: every year with information collected in the previous 12 months.
Licence holders are obliged to comply with the submission rules for as long as the device is authorised in Canada and may choose the date on which they submit the reports as long as it falls within the required timeframe: the date of submission of Summary Reports is not linked to the date of licensing of a Medical Device.
It is important to emphasise that non-compliance with Summary Reports, being part of the regulatory requirements applicable in the territory and necessary for the marketing of devices, affects the maintenance of compliance and could lead to reporting under the Medical Device Single Audit Programme (MDSAP).
Do you need support in preparing Summary Reports required to market MDs and IVDs in Canada?
Thema’s experts are available with strategic-regulatory consulting services to prepare and submit the required documentation, to act as your Canadian Regulatory Correspondent as well as to help with the registration of Medical Devices on the Canadian territory.
Contact us for more information.
