Updates to the guidance on medical device establishment licensing (GUI-0016)
MDEL Bulletin September 6, 2023, from the Medical Devices Compliance Program
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On September 6, 2023, Health Canada's Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL).
- incorporated the applicable sections of paragraphs 45 (h) and 45 (h.1) in the amended Medical Device Regulations (MDR)
- introduced sections 62.21 to 62.26
- aligned an MDEL requirement with the MDR
- clarified various sections of the document including submitting MDEL amendments
View the revised guide:
Key changes in the guide
We made the following key changes :
- updated common examples in Table 1 for when an MDEL is required under the Food and Drugs Act and the MDR
- including a reminder that an MDEL is issued to Class I manufacturers to permit them to import or distribute a medical device in Canada
- including that distributors outside Canada need an MDEL to sell a medical device in Canada
- updated examples in Table 2 for MDEL and medical devices licence (MDL) requirements and exemptions based on activity type
- added information for fees related to small business status
- updated diagram 1 to include rejection of the application for fee non-payment
- revised the timeline to submit amendments outside annual licence review period and clarified that establishments can make changes before the licence is updated
- added the definition for 'shortage for a medical device'
- revised the definition for 'site(s)' related to a medical device establishment licence as per paragraph 45 (j) of the MDR
- updated section outlining the key responsibilities of an MDEL holder for incident reporting, foreign risk notification for medical devices, and reporting medical device shortages and discontinuations
- changed the email addresses for the Medical Devices Establishment Licence Unit and Cost Recovery Invoicing Unit
For questions about medical device establishment licences and the application process, email the Medical Device Establishment Licence Unit: email@example.com.
For questions about invoicing and fees for an MDEL, email the Cost Recovery Invoicing Unit: firstname.lastname@example.org.
For information about methods for payment of fees and questions about your account, email our accounts receivable staff: email@example.com.
For questions about medical device shortage and discontinuation reporting, email the Medical Device Shortages Unit: MD.shortages.penurie.de.IM@hc-sc.gc.ca.
For questions about medical devices (including classification, labelling, clinical trials and obtaining a medical device licence), email the Medical Devices Directorate: firstname.lastname@example.org.
- Medical Devices Regulations
- Medical device establishment licence (MDEL) application: Instructions (FRM-0292)
- Small business mitigation for drugs and medical devices: How to apply for small business status
- Incident reporting for medical devices: Guidance document
- Foreign risk notification for medical devices guidance document: Background
- How Health Canada inspects medical device establishments (GUI-0064)
- Guide to reporting medical device shortages and discontinuations (GUI-0137)
- Date modified: