Health Canada on Medical Device Establishment Licensing

Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In particular, the authority describes the way the interested party shall apply for a medical device establishment license (MDEL) and also the regulatory requirements associated thereto.

The document is intended to provide additional clarifications and recommendations to be considered by importers and distributors of medical devices, as well as domestic manufacturers of Class I medical devices. Due to the legal nature of the guidance, it should be used for general informational purposes only. In the case of any discrepancies with the provisions of the applicable legislation, the latter shall prevail
The authority also mentions that due to additional restrictions imposed in the context of the outbreak of Coronavirus Disease 2019 (COVID-19), all applications should be submitted in electronic format.

Regulatory Background

As mentioned, the present Health Canada guidance provides additional clarifications regarding the regulatory requirements related to medical device establishment licenses. The scope of the document covers the following aspects:

The initial application for an establishment license,
Annual license review,
Changes and amendments to an existing license,
License withdrawal,
Restoring establishment license after being suspended.

First, the document provides an overview of the most important concepts used in the context of medical devices. In particular, the authority states that under the applicable risk-based classification, all medical devices are divided into classes from I to IV depending on the risks arising when using them. Consequently, the regulatory requirements for high-risk medical devices are much more strict and detailed than the ones applied to low-risk products. In certain cases, a product could consist of a medical device and another therapeutic product – for instance, a medical substance, while each of the components constitutes a regulated product itself. The term “combination products” is used for healthcare products consisting of two or more healthcare products. The provisions of the present guidance will be applicable for combination products classified as medical devices due to the primary mode of action.

As described above, an establishment license is required for the manufacturers of Class I medical devices and also for importers and distributors of medical devices of all classes. At the same time, the manufacturers of Class II to IV medical devices are obliged to apply for a medical device license (MDL) in order to be allowed to market their products in Canada. Any and all entities engaged in the importation or distribution of medical devices in Canada should hold a valid medical device establishment license.

The authority also outlines two main obligations of the license holder, namely:

Submit an annual license review application before April 1 of each year, and
Notify Health Canada within 15 calendar days if there is a change to information under paragraphs 45(a) and (b) of the Medical Devices Regulations.

It is important to mention that for the purpose of the guidance, the term “distribution” covers all actions performed to make a medical device available for healthcare professionals and patients, including lease or rent.

Medical Device Establishment License Requirements

The particular MDEL requirements to be applied will depend on the type of activity an entity intends to conduct. According to the document, a medical device establishment license is required in case of:

Importing medical devices produced by the foreign manufacturer to Canada for further selling;
Purchasing medical devices in Canada for the purpose of further reselling them;
Selling medical devices by foreign entities to healthcare facilities;
Selling medical devices by foreign manufacturers to Canadian importers;
Direct shipments of Class I medical devices to Canada by a foreign manufacturer.

At the same time, the license will not be required in the following cases:

Selling Class I medical devices by the foreign manufacturer to Canadian entity holding MDEL;
Selling Class I medical devices by a domestic manufacturer.

Foreign medical device manufacturers intended to market Class II-IV medical devices are obliged to have a medical device license (MDL) in order to be allowed to conduct such activity in Canada.

The medical device establishment license confirms that the medical device placed on the market, as well as all the procedures associated thereto, are compliant with the applicable regulatory requirements set forth by the national legislation.

The authority also mentions that the application for an MDEL shall contain an indication of the class of a medical device in question under the risk-based classification. It is the sole responsibility of the manufacturer to determine and indicate the appropriate class. In the case of imported medical devices, a responsible entity shall contact the manufacturer in order to get additional clarifications. Under the general rule, a medical device that meets the requirements of several classes should be assigned to the highest class.

According to the guidance, a license holder shall be able to demonstrate conformity with any and all requirements to be applied. The authority is entitled to carry out the appropriate inspections intended to assess compliance.

MDEL Exemptions

The present Health Canada guidance also describes exemptions under which the requirement to obtain an MDEL license could be waived. According to the document, a medical device establishment license is not required in case of:

Importing medical device for personal use without the intent to make available to third parties,
Retail (selling products directly to the users, conducted by resellers or manufacturers of Class 1 medical devices),
Healthcare facilities using medical devices for their internal purposes, including providing care and treatment,
Manufacturers of higher-risk medical devices provided that they hold the appropriate medical device license,
Manufacturers of Class I medical devices, provided that they make their products available only to the license holders,
Importing or selling medical devices intended for veterinary use only (the appropriate indication should be placed on the labeling of the device),
Importing or selling medical devices intended for special purposes (e.g., investigations) or custom-made products,
Storing medical devices without alienation of any kind.

The document further provides examples of various situations in which an establishment license should or should not be required. For instance, in case of subcontracting the manufacturing of Class I medical device, the entity which would be indicated as a manufacturer should have an establishment license. In the case of importing medical devices into Canada for the purposes of further exporting them to other countries, an establishment license would still be required. Selling medical devices to healthcare facilities also requires a valid MDEL, since healthcare facilities are not end-users for the purpose of the guidance. At the same time, healthcare facilities are allowed to purchase medical devices for their own needs without obtaining an establishment license. However, it will be required for the party from whom they are going to purchase medical devices.

In summary, the guidance document published by Health Canada provides an overview of the most important regulatory requirements related to medical device establishment license. In particular, the guidance describes the cases in which a valid MDEL would be required, as well as the cases when operations with medical devices could be conducted without it.

Sources:

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/pub-eng.pdf

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