Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the interpretation of significant changes to a medical device. In particular, the guidance describes the approach to be applied by the medical device manufacturer in order to determine whether the changes made to a Class III or IV medical device should be deemed significant and thus should trigger the requirement to apply for an amended medical device license before placing a modified medical device on the market.
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The document provides additional clarifications on the interpretation of the concept of a “significant change” introduced by the Medical Devices Regulations. The authority also states that the present guidance supersedes the one issued earlier in 2003.
It is important to mention that guidance documents issued by Health Canada describe the recommended approach parties involved may use to ensure compliance with the applicable regulatory requirements. They do not introduce new rules and requirements themselves. Moreover, the authority reserves the right to introduce new rules, impose new obligations, and request additional information beyond the scope of the present guidance, should it be reasonably necessary to ensure the safety and effectiveness of medical devices intended to be marketed and used in the country.
Regulatory Background
As mentioned, the present Health Canada guidance explains in detail the concept of a “significant change” in the context of requirements related to the submission of an application for an amended medical device license for Class III or IV medical devices under the Canadian risk-based medical device classification.
Under the general rule, a medical device license is required for Class II, III, and IV medical devices. At the same time, the requirement related to applying for an amendment medical device license applies only for Class III and IV medical devices.
As stated by Health Canada, the document provides a three-phase assessment tool that includes: general principles in identifying a significant change; a series of flow charts to aid in decision making; and a list of significant and non-significant change examples.
In general, the regulatory measures addressed in the guidance are intended to ensure the continuous safety and effectiveness of Class III and IV medical devices subject to modifications.
Policy for Significant Changes
According to the guidance, a medical device manufacturer is obliged to apply for an amended medical device license with regard to the modified device. The latter should be placed on the market only after obtaining an amended license from the regulating authority. At the same time, there are certain exclusions to be considered. For instance, a labeling change that adds a contradiction, warning or precaution vital to public health and safety should be implemented immediately, with a simultaneous license amendment application being sent to Health Canada. In such a case, a manufacturer should also provide a sufficient justification for immediate change. Health Canada’s guidance states that the review timeframe will depend on the nature of changes introduced, as well as potential patient safety concerns.
Should the change to a medical device be determined as not sufficient to trigger the requirement to apply for an amended medical device license, such change should be duly documented in the Quality Management System and later reported to the regulating authority in the course of annual license renewal. The information about all the changes made during the reporting period should be provided in a structured way and contain a brief description of changes themselves as well as the indication of dates.
It is important to mention that the scope of the present Health Canada guidance covers only the approach to be applied by a medical device manufacturer when determining whether the changes made to a medical device qualify as “significant.” All aspects related to the submission of an application for an amended medical device license, including its structure, content, as well as regulatory procedures associated thereto fall outside of its scope. The document also provides recommendations on assessing the impact of several changes to a medical device in terms of the impact caused by each change separately as well as their collective impact. Irrespective of the nature of changes made, a side-by-side comparison to a medical device already placed on the market could be applied in order to assess the impact of such changes and their significance.
Another important aspect relates to changes made to a medical device system, test kit, group, family, or group family. The authority states that changes to any of the components thereof should be subject to separate assessment plus the assessment of an overall impact on safety and performance. The authority mentions that, in certain cases, an application for a new medical device license could be required instead of an application for an amended medical device license.
The scope of the present guidance covers possible changes to the design, functionality, manufacturing, packaging, finishing, and labeling of a medical device. However, the cases explained in the guidance are not exhaustive, and in case of any concerns regarding the way the regulatory requirements should be interpreted, a medical device manufacturer shall contact the regulating authority to get additional clarifications.
Definitions
In order to assist medical device manufacturers in applying the provisions related to change control requirements, the guidance also provides the definitions of the most important terms and concepts used in the context of the matter.
The definitions provided in the document include the following:
- Cautions and precautions – information which alerts the user to exercise special care necessary for the safe and effective use of the device;
- Contradictions describe situations where the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits;
- Control mechanisms should be interpreted as means of verifying or checking that the specifications or outputs of the device meet a standard or predetermined result;
- Warning describes serious adverse reactions and potential safety hazards that can occur in the proper use, or misuse, of a device, along with the consequent limitations in use and mitigating steps to take if they occur.
Apart from those listed above, the document also provides definitions of such terms as “facility,” “indications for use,” “operating principles,” “recall,” “significant change,” and “surgically invasive device.”
In summary, the present Health Canada guidance on change control requirements addresses the aspects related to the interpretation of a “significant change” concept in terms of the obligation of a medical device manufacturer to apply for an amended medical device license, should the changes made to a medical device impact significantly on its safety and/or performance. The document highlights the most important issues to be considered when determining whether the particular changes made are significant enough to trigger the aforementioned requirement.
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