Health Canada, the country’s regulating authority in the sphere of medical devices, has published guidelines on special framework for importation and sale of medical device devices intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.”
The document is intended to provide additional clarifications with regard to the regulatory requirements introduced by virtue of the appropriate Interim Order to ensure and expand the availability of vitally important medical devices during the pandemic. It is important to mention that in comparison to similar temporary frameworks introduced in other countries, certain regulatory flexibilities announced by Health Canada will remain applicable even when the public health emergency will cease to exist.
Key Points of the New Framework
- New rules are intended to streamline and simplify the process of placing new COVID-related medical devices on the market in order to ensure their uninterrupted availability;
- Special transitional regime to be introduced before the new framework will take effect;
- The particular rules to be applied would depend on the class of the medical device in question under the risk-based classification;
- For importing and distributing medical devices associated with the lowest risk, a medical device establishment license would be sufficient, while the medical device license for the particular product is not required;
- For importing and distributing higher-risk medical devices, a transitional medical device license is required. Later it should be replaced with an ordinary medical device license;
- The transitional period is two years.
Regulatory Background
The present Interim Order introduces special rules intended to simplify the process of placing new medical devices on the Canadian market, provided such devices are to be used to diagnose, treat, mitigate or prevent COVID-19. As mentioned before, the authority intends to keep the measures introduced by the Interim Order applicable after the pandemic. The initial period the measures will remain in force is two years, which could be used by the medical device manufacturers to achieve compliance with the general rules for medical devices, under which each product requires a medical device license.
The authority has also carried out a 3-weeks consultation intended to collect feedback from industry representatives with regard to the new framework. The suggestions received have been taken into consideration for further development of rules and regulations. The authority continues its ongoing oversight with regard to medical devices used in the context of the COVID-19 outbreak in order to ensure their safety and effectiveness.
Amended Framework for COVID-related Medical Devices
The present Health Canada guidance describes the rules implemented under the second interim order that remain valid from March 2021 until fall 2021. According to the document, the key points of the new interim order are the following:
- The parties involved in operations with medical devices will have six months to apply for a medical device establishment license (MDEL) required to carry out certain types of licensed activities,
- The labeling of medical devices should be bilingual (the same transitional period applies).
Further, the document describes the regulatory requirements to be applied depending on the class of the medical device in question under the risk-based classification.
1. Class I medical devices. At the moment, it is allowed to import and distribute medical devices assigned to the lowest risk class under a temporary Class I license. Upon expiration of 18 months after the new framework takes effect, a medical device establishment license will be required for entities interested in carrying out operations with such devices. Application for a license of this type will be subject to the appropriate fees payable by the applicant. If the interested party has already applied for such a license, the application will be reviewed by the regulating authority in accordance with the usual procedure, and the license will be granted. Later, upon expiration of the aforementioned term, the holder of such a license will still have to apply for a medical device establishment license.
2. Higher-risk medical devices (Classes II, III, and IV). The regulatory regime applicable to higher-risk medical devices is a bit different. As stated by Health Canada, current authorizations will be deemed equal to the medical device licenses issued under the Medical Devices Regulations and remain valid for two years. In order to obtain a general medical device license, the manufacturer would have to submit a complete set of documents demonstrating the product in question complies with any and all applicable regulatory requirements. Upon expiration of the aforementioned two-year period, the license holder will have to (a) obtain a Medical Device Single Audit Program Quality Management System certificate and (b) provide evidence of the measures taken in order to comply with the requirements for authorization under the Interim Order. In the case of medical devices associated with the highest risk (Class III and IV), the manufacture would also have to provide additional evidence in the form of data or reports.
Irrespectively of the class of the medical device in question under the risk-based classification, the responsible entity would have to sustain compliance with the regulatory requirements related to post-market monitoring and adverse events reporting.
Once the medical device license issued under the Medical Devices Regulation has been granted, an interested party shall pay the applicable fees. An additional fee applies in case of changes made to a medical device, provided such changes require amendments to the dossier of the product. As in the case with Class I medical devices, the regulating authority will continue the review of the applications submitted, as well as grating transitional medical device license, which will remain valid during the transitional period (two years). In order to be allowed to market their products upon expiration of this term, the medical device manufacturers would have to achieve and sustain compliance with any and all applicable regulatory requirements.
In summary, the present Health Canada guidance describes special measures implemented in order to ensure the availability of vitally important medical devices during the pandemic. The document describes the regulatory requirements to be fulfilled by the manufacturer in order to be allowed to market its products on the Canadian market. The document outlines the particular rules to be applied depending on the class of the medical device subject to review under the risk-based classification. In particular, it provides additional clarifications with regard to the way the transitional regime rules should be applied, and also on the authorisations and permissions needed in order to be allowed to market COVID-related medical devices.
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