Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is in accordance with proposed amendments under section 36 of the Medical Devices Regulations (MDR). These proposed regulations will allow Health Canada to expand the scope of use of T&Cs and impose and amend T&Cs at any time during the medical device’s life cycle.
This guidance document applies to T&Cs imposed on Class II to IV medical device licences under subsection 36(2) of the MDR.
This guidance document does not address the following T&Cs:
The objective of this change is to ensure that T&Cs are imposed and amended fairly and consistently and that regulated parties are given an opportunity to voice their concerns or submit suggested modifications to the T&Cs before they are imposed.
The purpose of T&Cs is explained in the document, outlining the process that will be applied when T&Cs are imposed on Class II to IV medical device licences or when they are amended (which includes the removal of T&Cs).
The proposed regulations will give the Minister power to impose and amend T&Cs on Class II to IV medical device licences at any time during the device’s life cycle. This will encourage medical device manufacturers to take steps to address the safety, effectiveness, risks, and benefits of their products.
Health Canada’s ability to oversee and asses devices will be enhanced under this proposal. This will allow Health Canada to identify issues sooner and address them faster through the oversight provided by T&Cs.
It is important to note that Health Canada is not changing the issuance requirements for medical device licences.
At the moment, the Minister may impose T&Cs on a medical device licence requiring that manufacturers:
The Minister may also amend T&Cs imposed on a medical device licence to capture any new developments with that device.
With the proposed amendments T&Cs may be imposed on Class II to IV medical device licences at the time of licensing or any time after. T&Cs may also be amended at any time.
The goal of imposing or amending T&Cs is to meet the following objectives:
The Minister will consider the following before imposing or amending a T&C:
Medical device licences may be issued with or without T&Cs. These T&Cs may be imposed or amended at any time post-market. Each T&C may also have a different timeline in which it must be fulfilled and there is no limit on the number of T&Cs or amendments that may be imposed on a licence.
Here are a few examples of circumstances that may require a T&C to be imposed or amended:
Here are some examples of what medical device manufacturers may be required to provide through T&Cs:
These examples may be applied upon licensing, after licensing, or both.
Amending a T&C involved either modifying or removing a T&C. Here are a few examples of when Health Canada may modify a T&C:
Both Health Canada and the manufacturer may request an amendment to a T&C, although in general Health Canada will initiate the amendments. Should a manufacturer wish to have a T&C amended, they have to provide Health Canada with the following for the Minister’s consideration:
When imposing a new T&C or amending an existing one on a medical device, Health Canda will inform the manufacturer in writing with the following, as applicable:
The manufacturer will have up to 10 calendar days to submit a response before the T&C comes into effect. Manufacturers may voice their concerns or submit modifications to the proposed T&C during this 10-day period. The Minister will consider any submission and issue a decision along with a rationale with the final T&Cs.
Section 21.7 of the Food and Drugs Act (FDA) requires medical device licence holders to comply with T&Cs with all T&Cs being enforceable under the MDR and the FDA. Health Canada may consider pursuing compliance and enforcement measures against manufacturers that fail to comply. Non-compliance with T&Cs can lead to:
A licence holder may be liable to fines or imprisonment.
Health Canada will begin to publish all information about all T&Cs imported on medical device licences, including new and amended T&Cs. This will be done to increase transparency and communicate risks to people in Canada. These summaries will look to be published regularly and will not include the following
This article provides a supplemental review of Health Canada’s draft guidance document, “Draft guidance document: Terms and conditions for medical devices“, and is not a substitute for reading the full draft guidance.
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