Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to medical device license applications for ultrasound diagnostic systems and transducers.
The document provides additional recommendations regarding the content of license applications and other important aspects associated thereto. The clarifications provided in the document are based on the regulatory requirements set forth by the Medical Device Regulations, which are mandatory for any and all medical devices intended to be marketed and used in Canada.
The present guidance has been updated several times in order to ensure it reflects all the modifications necessary due to amendments to the relevant legislation since Health Canada published the initial version of the guidance. The changes are mostly related to the information and documentation to be provided by an applicant in order to demonstrate that the medical device in question meets the applicable requirements in terms of safety and performance. However, the scope of the guidance does not cover cases when the party responsible for a medical device applies for amendments to a device license already issued by the authority. In this regard, the authority refers to the appropriate Guidance for the Interpretation of Significant Change. Should the applicable regulatory requirements change, the authority reserves the right to amend the guidance and recommendations provided therein.
In general, guidance documents developed and published by Health Canada are intended to provide additional clarifications regarding how the provisions of current legislation should be interpreted and to assist medical device manufacturers and other parties involved in applying them. Health Canada staff should also consider these guidelines to ensure transparency, consistency, and predictability of the regulatory procedures.
At the same time, the recommendations provided in guidance documents are not mandatory. In the event of any discrepancies with the corresponding provisions of current legislation, the latter should prevail. Consequently, an alternative approach could be applied, provided it complies with the regulatory requirements and has been approved by the authority in advance. However, Health Canada also reserves the right to request additional information and documentation beyond the scope outlined in this guidance, should it be reasonably necessary to assess the safety and effectiveness of medical devices intended to be placed on the market.
The present guidance addresses the regulatory matters related to the device license applications for Class III or IV ultrasonic diagnostic systems and transducers.
The basic regulatory requirements for Class III and IV medical devices are prescribed by the aforementioned Regulations. In particular, Sections 32(3) and 32(4) describe the scope of evidence to be provided by the applicant in order to demonstrate compliance with the requirements on safety and performance. Due to the relatively high risks the persons using the devices of such classes are exposed to, the authority requires the evidence of conformity to be rigorously assessed before the device is allowed for marketing and use. The particular scope of documentation a new application for a device license shall contain depends on the class of the medical device in question under the current Canadian risk-based classification. The license could be granted only under the condition that the device complies with all applicable requirements and all documentation necessary to demonstrate this is in place and has been provided to the authority in the course of a premarket review.
In particular, the present Health Canada guidance describes device-specific regulatory requirements to be applied in the case of Class III and Class IV ultrasonic diagnostic systems and transducers instead of general requirements that are applicable to all medical devices. The authority states that in the event of any contradictions with the general requirements, device-specific requirements shall prevail. As mentioned, any amendments made to a device license after it is initially issued fall outside the scope of the present guidance.
Requirements for an Application
The guidance further describes in detail the regulatory requirements related to the content of an application for a device license related to Class III medical devices. According to the document, any license application should be structured in accordance with the recommendations provided by the authority in order to facilitate its review. It is stated that a device license application should have the following structure:
- Background Information
- Device Description,
- Design Philosophy,
- Marketing History.
- Summary of Safety and Effectiveness Studies
- List of Standards,
- Methods of Sterilization,
- Summary of Studies,
- Quality System Requirements.
In the case of any deviations from the recommended structure described above, the applicant will have to provide detailed enough justifications for such deviations. This approach should be applied if the applicant deems some sections to be not applicable in its particular case.
The authority also mentions that the information provided in a format required by a foreign regulating authority (e.g., the US Food and Drug Administration or FDA) would also be admissible. However, it should be structured in a way as described above.
In most cases, under the current Canadian risk-based classification for medical devices, ultrasonic diagnostic systems and transducers are Class III medical devices. However, those intended to be in direct contact with the central nervous system or the central cardiovascular system are subject to a special exception. In such cases, another classification rule should be applied. Hence, such products should be classified as Class IV medical devices, so the regulatory requirements they will be subject to should change accordingly. Therefore, the scope of information and documentation the regulating authority will require with regard to such devices will be slightly different. In particular, an applicant will also have to provide:
- Details about the risk assessment, including risk analysis and evaluation, as well as the information about the special measures implemented by the manufacturer in order to mitigate such risks;
- A quality plan describing in detail the activities related to the product;
- Detailed information regarding the materials used for the device itself and its packaging;
- Description of the medical device manufacturing process;
- Additional details on the studies the applicant refers to when demonstrating compliance with the applicable requirements, including pre-clinical (not required if previously licensed), process validation studies, software validation studies (not required for transducers), literature studies (not required for established technology).
In summary, the present guidance describes in detail the regulatory requirements Class III and Class IV ultrasonic diagnostic systems and transducers should comply with in order to be allowed for marketing and use in Canada. The regulating authority highlights the most important points related to the content of a new device application and provides recommendations regarding its structure.
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