As a result of the COVID-19 public health emergency, there is an increase in the importation of disinfectants, sanitizers and personal protective equipment (PPE) such as protective masks, hand sanitizer, and medical gowns.
Health Canada has enacted emergency measures to facilitate and expedite access to licensing and registration requirements for disinfectants, hand sanitizers and personal protective equipment intended to help limit the spread of COVID-19.
Canada Border Services Agency (CBSA) has issued a notice for using the Imported Goods for Emergency Use in Response order related to the COVID-19 health emergency. This notice provides guidelines concerning the use of the order and application of Tariff Item No. 9993.00.00 in response to the emergency. In conjunction with the order, tariff no. 9993.00.00 allows for the relief of duty and tax on medical devices required by and imported on behalf of federal, provincial or municipal healthcare and emergency response teams or facilities.
Canadian importers should note medical devices are categorized into four classes (Class I, II, III IV) by Health Canada based on the level of risk associated with their use.
There are two primary types of licenses issued by Health Canada for medical devices sold in Canada. The first is a license for the actual device itself and the second is a license for the applicable company or establishment. The device license is called a Medical Device License (MDL) while the establishment license is called a Medical Device Establishment License (MDEL).
An MDL is issued to the manufacturer of class II, III, or IV devices by the Medical Devices Bureau (MDB) of the Therapeutics Products Directorate based on review of scientific evidence for quality, safety and efficacy
The MDEL is issued for the activities of importing and selling medical devices for human use in Canada. With few exceptions, generally any party importing or selling medical devices for human use require an establishment license.
MDEL applications for Class I medical devices related to COVID-19 can be submitted for expedited review using the MDEL Application Form (FRM-0292) available on Health Canada’s website. The completed MDEL application form should be sent to firstname.lastname@example.org.
Masks or respirators to protect against pathogens or prevent exposure to disease, such as surgical masks or N95 respirators are considered medical devices and regulated by Health Canada. Surgical Masks and N95 Masks are Class 1 medical devices. Importers are required to hold a MDEL.
Isolation and surgical medical gowns used by medical facilities are also regulated by Health Canada as a medical device. Medical gowns are considered Class I devices and importers, other than healthcare facilities, are required to hold a MDEL.
Gloves used for patient examinations or surgical purposes are again regulated by Health Canada and considered a Class II medical device. These types of devices require both a valid MDL and that the importer, other than healthcare facilities, hold an MDEL for human therapeutic use in Canada.
In Canada, for import purposes, disinfectants are generally considered non-prescription drugs, while hand sanitizers are considered natural health products (NHPs) or non-prescription drugs based on the product’s ingredients. In order to sell a topical hand antiseptic in Canada, market authorization from Health Canada is required.
Delmar continues to closely monitor all trade developments including those related to COVID-19. For additional information and assistance, please contact your local Delmar Representative or our Canadian Customs Advisory Services team at email@example.com.