Guidance on medical device establishment licensing (GUI-0016): What to do if we suspend or cancel your MDEL

On This Page

• Overview
• If your licence is suspended
• If your licence is cancelled
• Dispute process

Overview

Health Canada may suspend or cancel an MDEL in accordance with the Medical Devices Regulations (MDR).

If your medical device establishment licence (MDEL) is suspended or cancelled, you must immediately stop importing or selling medical devices. If you fail to do so, we may take compliance and enforcement actions. The actions we may take are outlined in the following policy:

• Compliance and enforcement policy for health products (POL-0001)

If your licence is suspended

Health Canada may suspend an MDEL when we have reasonable grounds to believe that:

• you (as the MDEL holder) have contravened the MDR or any provisions of the Food and Drugs Act (act) related to medical devices
• you have made a false or misleading statement when applying for your licence
• not suspending your MDEL would constitute a risk to the health or safety of patients, users, or other persons

When making a decision to suspend (under section 49 or 50 of the MDR), we consider the MDEL holder’s compliance history. We also consider the risk to the health or safety of patients, users, or other persons if we were not to suspend.

Before suspending your establishment licence under section 49 of the MDR, we will notify you in writing and outline:

• the reason(s) for the suspension
• the action(s)/corrective measure you failed to take within a prescribed timeline following an inspection
• the process giving you the opportunity to be heard

If we decide to suspend your licence under section 50, you will not be given an opportunity to be heard before the suspension takes effect. This is to prevent injury to the health or safety of patients, users, or other persons. We will notify you in writing and outline:

• the reason(s) for the suspension
• the instructions on how to be heard if you disagree with the suspension

Reinstating a suspended MDEL

You may submit an application to reinstate your licence if you want to resume selling or importing medical devices after we suspend your MDEL.

To reinstate an MDEL after suspension, you must correct the problems that caused the suspension.

To be considered for reinstatement, your establishment will need to submit documentation with the application to demonstrate that the situation(s) that gave rise to the suspension has been corrected. The documentation can include an adequate corrective action plan (CAP) or corrective and preventive actions (CAPA).

Once you have corrected the problems, you must submit:

• an MDEL application form (FRM-0292)
  • follow the same steps described in the section on applying for a licence
• payment within 30 calendar days from the date of invoice
  • refer to the section “After you submit your application” for information on fees and invoicing

If the MDEL fees have not been paid, Health Canada has the authority to withhold services, approvals, rights, or privileges.

For more information about fees related to MDELs, consult:

• Fees for the review of medical device establishment licence applications
• How to pay your establishment licence fees

We will reinstate your MDEL if:

• your application meets all the requirements under section 45 of the MDR
• we have verified that you have corrected the problems that caused the suspension

Once the suspended MDEL has been reinstated, you may resume licensable activities.

If your licence is cancelled

The Minister or delegated authority must cancel an MDEL when:

• your licence has been suspended for a period of more than 12 months
• you do not submit an annual licence review application before April 1 of each year

Applying for a licence after it’s been cancelled

Health Canada's authority to reinstate an MDEL is limited to suspended MDELs. If an MDEL is cancelled and the establishment wishes to resume activities, you must apply for a new MDEL and meet the requirements set out in section 45 of the Medical Devices Regulations, as applicable.

If cancelled following a suspension, you must first correct the problems that caused the suspension and cancellation. To do so, you must:

• submit documentation with the application to demonstrate that the situation that gave rise to the suspension and cancellation has been corrected
  • documentation may include adequate corrective and preventive actions (CAPA) or a corrective action plan (CAP)
• submit an MDEL application form (FRM-0292)
  • follow the same steps described in the section on applying for a licence

Payment is due within 30 calendar days from the date the invoice was issued. If the fee is not paid in full within 30 days of this date, Health Canada will place the application on cost-recovery hold. All work associated with the application will stop. When an application is placed on cost-recovery hold, the countdown against the 120-day service standard is halted.

If the fees are not paid when they are due, we have the authority to withhold services, approvals, rights, or privileges. If we use this authority to stop the review of an application, the period of time where services are withheld does not count toward our 120-day service standard.

For more information about fees related to MDELs, consult:

• Fees for the review of medical device establishment licence applications
• How to pay your establishment licence fees

You will be issued a new MDEL:

• if your application meets all the requirements under section 45 of the MDR
• we have verified that you have corrected the problems that caused the suspension and cancellation

Once a new MDEL number has been issued, you may resume licensable activities.

Disputes process

To begin a dispute process or to have the opportunity to be heard about a licence suspension and/or refusal, you should contact the Medical Devices Establishment Licence Unit.