Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to inspections of medical device establishments. The document outlines the main principles of inspections to be carried out by the authority and describes how the authority will assess compliance with the particular regulatory requirements set forth under the existing legislation.
Compliance With the Food and Drug Act
According to the guidance, the entities involved in manufacturing, promoting, or marketing medical devices should achieve and sustain compliance with the appropriate requirements set forth under the Food and Drugs Act. The present guidance provides additional recommendations to assist the parties involved in complying with these requirements and clarifies how such requirements should be applied in specific cases. In particular, it is stated that in the course of an inspection carried out by representatives of the regulating authority, the latter would pay special attention to checking whether the establishment subject to inspection conducts any prohibited activities and whether it complies with other applicable provisions of the Act.
The main aspects to be considered in this regard are the following:
- The entity should neither advertise nor offer to the general public the medical devices intended to be used in the context of certain diseases and conditions listed in Schedule A of the Act.
- Neither entity should make available medical devices exposing patients to additional hazards when used for the intended purpose in a way described by the manufacturer.
- The information accompanying the device placed on the market, including that which is contained in its labeling and packaging, or communicated in any other way, should not be incorrect, misleading, or misrepresent the device, its functions and features, or the safety-related issues associated thereto. In this regard, the authority additionally emphasizes that granting a medical device or a medical device establishment license should not be construed as an approval of any kind granted to the medical device or its manufacturer. The scope of such licenses is limited solely to placing a medical device on the market in accordance with the applicable legislation or performing other activities covered by the scope of the license. It is explicitly prohibited to indicate that the device has been “approved by Health Canada” or use similar wording. It is also prohibited to include the logo of the regulating authority on the labeling or on any other materials accompanying the device, as this would be treated as misleading. Moreover, it is stated the one is prohibited from labeling and packaging devices unless they meet the requirements of the Regulations.
- It is also prohibited to market any article as a medical device unless it meets the applicable regulatory requirements.
Thus, the requirements set forth by the Food and Drugs Act are mostly general in their nature and establish the main principles in terms of activities to be carried out by establishments.
Compliance With the Medical Devices Regulations
Another section describes factors to be considered by inspectors when assessing the compliance of a medical device establishment with the regulatory requirements set forth under the Medical Devices Regulations. It also provides additional clarifications for the parties involved on how these requirements should be interpreted.
Key points covered by this section include:
- A medical device manufacturer is solely responsible for determining the proper classification of a medical device in question in accordance with the applicable Canadian risk-based classification of medical devices. The particular rules to be applied are prescribed in Schedule 1 of the Regulations. Should a manufacturer fail to determine the class of a medical device subject to review correctly, this could potentially result in further failures to comply with the applicable regulatory requirements.
- A medical device manufacturer is also responsible for demonstrating compliance with the applicable requirements in terms of safety and effectiveness. In this regard, the spheres to be covered by an inspection will include design, manufacturing of a medical device, proper identification of risks associated thereto, as well as ensuring the device will not cause harm to patients when being used for the intended purpose and in accordance with the instructions to be provided by the manufacturer. The device should be suitable for its intended purpose, and the clinical benefits it provides should outweigh identified and potential risks associated thereto. Another requirement states that the device should not be harmed in the course of transportation or storage, provided that the appropriate recommendations provided by the manufacturer are met. The scope of an evaluation will also cover the materials used to manufacture medical devices in terms of compatibility. Special requirements will be applied for medical devices claimed as sterile – the inspector will evaluate the effectiveness of the sterilization method used and the controls used to ensure sterility. Should the device be intended to be used together with other devices, the evaluation will also cover various aspects related to compatibility. In the case of software, additional validation will be performed to evaluate its performance. It is also stated that the inspector is entitled to request additional information and supporting documentation reasonably necessary to assess the actual safety and performance of a medical device.
- As in the case with the Food and Drugs Act, the Medical Devices Regulations also prohibit making available devices that could cause harm to patients when being used properly for their intended purpose.
- Upon completion of the evaluation, the inspector is entitled to issue observations. According to the guidance, in most cases, such observations are related to the effectiveness for the intended use (in case the manufacturer fails to support the claims made with regard to the performance of the product) and transport and storage (in case of reasonable concerns regarding compliance with the requirements related to properly storing and transporting medical devices to ensure their continued safety and effectiveness).
- Additionally, the scope of an inspection will cover the assessment of compliance with the labeling requirements, especially for Class I and II medical devices since they are currently allowed to be placed on the market under a simplified procedure that does not require a mandatory review of labeling. For the purpose of this provision, the concept of “labeling” covers not only the label itself but also any information supplied with the device, including operating manuals, brochures, and leaflets. These elements should also comply with the language requirements – in the case of devices intended to be offered to the general public, all important information should be provided in English and French. In the course of an assessment, the inspector will consider all the product lines offered by the manufacturer, as well as inspection and compliance history in terms of labeling.
In summary, the present Health Canada guidance describes the way the inspector will assess compliance with the specific regulatory requirements set for by the applicable legislation. In particular, the scope of the guidance covers the requirements related to the manufacturing processes and also labeling and adverting medical devices.
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