Health Canada has published a notice summarizing the most important aspects related to the Interim Orders (IOs) in the context of the outbreak of COVID-19 and special regulatory measures associated thereto. The document is intended to provide medical device manufacturers and other parties involved with additional information and clarifications regarding certain flexibilities by the mean of the IOs, and also to highlight the expected changes to the regulatory framework.
Interim Order: Basics
According to the official notice, starting from March 2020, Health Canada has already issued 5 IOs dedicated to the most important matters in the context of the COVID-19 outbreak. In particular, the document refers to the following interim orders:
- Interim order – importation and sale of medical devices,
- Interim order – permitting exceptional importation of key products,
- Interim order – clinical trials for medical devices and drugs,
- Interim order – importation, sale, and advertising of drugs,
- Interim order – prevention and alleviation of drug shortages.
Health Canada states that such a legal instrument as an interim order provides the possibility of implementation of certain regulatory flexibilities or special temporary and extraordinary measures within a relatively short period of time, which becomes vitally important during the pandemic. The authority also mentions that the COVID-related regulatory flexibilities are expected to be in force at least for one additional year. Later Health Canada intends to implement the changes to the current regulation in order to expand the validity of the aforementioned flexibilities further.
The regulating authority also mentions that it intends to collaborate with all industry representatives in order to develop an optimal approach towards the amendments to the country’s legislation on medical devices. In particular, Health Canada is going to carry out public consultations regarding the most important regulatory matters.
Interim Order on Clinical Trials for Medical Devices and Drugs
One of the most important interim orders issued by Health Canada addresses the issues related to the clinical trials for medical devices and drugs related to the COVID-19 outbreak. The document describes certain extraordinary measures to be implemented in order to address the issues related to the pandemic. The document was initially published on May 23, 2020.
With regard to medical devices, the scope of the interim order covers the ones intended to be used in the context of the Coronavirus Disease, except Class I medical devices.
According to the interim order, the Medical Devices Regulation do not apply to the importation and sale of a COVID-19 medical device that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device if those activities are authorized by a COVID-19 medical device authorization and the authorization has not been revoked. This rule has been introduced in order to reduce the regulatory burden for the parties interested in placing COVID-related medical devices on the market in the course of special measures intended to ensure and expand the availability of vitally important medical devices during the pandemic. In order to benefit from the aforementioned exclusion, an interested party shall submit the appropriate application for medical device authorization. Such an application should be provided in the form set forth by the Minister and contain the information necessary for Health Canada to access the case including, inter alia, the following:
- The name of the interested party applying for authorization and its contact details (and the same for the importer, if applicable),
- The name of a medical device in question and its class under the risk-based classification,
- The general description of the medical device subject to review, including necessary information about the materials the device is composed of, as well as about its packaging,
- The indication of the intended purpose of a medical device, and also the description of its functions and features,
- The identifier of the medical device,
- The information about the medical device manufacturer, including its name and contact details,
- The indication of a location of manufacturing facilities,
- The indications regarding the intended use, including the appropriate references to the diagnosis, treatment, mitigation, or prevention,
- The information about sales history of a medical device, covering such aspects as the countries the device is currently available, sales volume, and also any incidents associated with the device,
- All important safety-related data,
- All necessary directions for the use of the device, except cases when the way the device should be used in a safe and efficient manner is obvious, and thus such directions are not needed,
- The declaration from the interested party with regard to the procedures related to record-keeping and post-market activities, such as complaints handling or incident reporting,
- Sample of the labeling,
- The information about the qualified investigator(s), including names and qualifications, training and experience,
- The information about the institution intended to participate in clinical trials,
- Clinical trials protocol, which should cover such aspects as the objectives, planned duration, and other important matters,
- A written undertaking from the qualified investigator regarding sustaining compliance with any and all applicable rules and requirements,
- The information about the research ethics board (only for Class III and Class IV medical devices).
It is also important to mention that in the case of Class II medical devices certain points from this list provided here above could be waived.
Issuance of the COVID-19 Medical Device Authorization
The interim order on clinical trials for COVID-related medical devices also describes the requirements and conditions related to the issuance of a COVID-19 medical device authorization by the Minister. According to the document, the aforementioned authorization could be granted by the Minister providing that:
- The appropriate application has been submitted by the interested party, and such an application meets any and all applicable requirements,
- The interested party has also provided the regulating authority with all necessary information requested in the course of application review,
- As determined by the Minister, the medical device in question would not cause a negative effect on the health of patients participating in a clinical trial, the goals and objectives of the trial are clear and achievable, and such trial does not contradict the interests of its participants.
It is also important to mention that the interested party intended to import and market COVID-related medical devices should also obtain the approval of a research ethics board for each clinical trial site.
The regulating authority also emphasizes that additional requirements or preconditions could be implemented if it would be reasonably necessary to ensure the safety of patients participating in clinical trials.
In case of significant changes to the medical device covered by the scope of the application, the responsible entity shall duly submit the amendments to the authorization.
Summarizing the information provided here above, Health Canada issues the interim orders in order to implement additional flexibilities or special extraordinary measures of temporary nature intended to ensure and expand the availability of medical devices during the pandemic. One of the most important interim orders issued by the regulating authority addresses the matters related to the clinical trials for medical devices intended to be used in the COVID-related context.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
