Names of medical device establishments’ senior officials to be posted
MDEL Bulletin, July 28, 2021, from the Medical Devices Compliance Program
On this page
- MDEL holder responsibilities
- What's changing
- Why it's changing
- Action required by MDEL holders
- Contact us
MDEL holder responsibilities
Holders of a medical device establishment licence (MDEL) must have procedures (for example, recall, complaint handling, distribution records) in place to protect individuals, should a problem arise. As part of the MDEL application process, the senior official of the establishment is required to attest to this. This requirement is outlined in paragraphs 45(g), (h) and (i) of the Medical Devices Regulations.
MDEL holders must also:
- keep their licence information up to date
- inform Health Canada of any changes related to their activities or contact
What's changing
In September 2021, Health Canada will be posting senior officials' names on the public medical devices establishment licence listing. This webpage already includes information about the licensed establishment, such as the:
- company ID
- licence number
- company name
- address
- authorized activities
- associated class of device
Why it's changing
Health Canada is posting senior officials' names in an effort to raise the accountability of MDEL holders in complying with the regulatory requirements.
The senior official attestation is the basis for which Health Canada issues a MDEL, permitting holders to manufacture, import and distribute medical devices in Canada.
The attestation gives assurance that establishments have procedures in place to enable an effective medical device recall and protect people if there is a post-market safety problem. Not having the required procedures in place is a critical risk, for which Health Canada can suspend, and has suspended, MDELs.
Licence holders are reminded of their regulatory responsibility for including accurate and compliant information in their MDEL applications and annual licence reviews.
Action required by MDEL holders
Senior officials must ensure that the relevant procedures are in place before they provide an attestation in their MDEL application.
Establishments are responsible for confirming that the senior official's name identified in their MDEL is correct.
To change the name of the senior official on your MDEL, you must submit an amendment application to Health Canada. You may:
- email us at hc.mdel.application.leim.sc@canada.ca
- fill out the annual licence review (ALR) application between December and March of each year or
- use FRM-0292 any other time during the year
Note: Since an establishment licence contact and senior official are not always the same individual, it is important to ensure both contacts are up to date on the licence. Changes to the licence contact information must be submitted to Health Canada within 15 calendar days of the change through a notification application as per section 48 of the Medical Devices Regulations.
For more details, please refer to Guidance on medical device establishment licensing (GUI-0016).
Contact us
For questions about MDELs, please email us at hc.mdel.questions.leim.sc@canada.ca.