Health Canada – Importation of Masks, Medical Gowns, Gloves and Hand Sanitizers

Updated May 7, 2020 – This document provides information on the importation of Personal Protective Equipment (PPE) and sanitizer products into Canada.

Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, there has been an increase in the importation of protective masks, medical gloves, medical gowns and sanitizing products.

Health Canada has issued a notice to industry on interim measures for manufacturers, and importers on disinfectants, hand sanitizers, personal protective equipment (such as masks and gowns) and swabs in relation to the COVID-19 pandemic. The notice outlines Health Canada’s measures to facilitate and expedited access to licensing and registration requirements for disinfectants, hand sanitizers, disinfectants and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing.

The Canada Border Services Agency (CBSA) has issued three relevant Customs Notices to assist importers of medical supplies.

  1. Customs Notice 20-19 provides importers with information on the Certain Goods Remission Order (COVID-19), which allows for the relief of customs duty for eligible goods which were imported on or after May 5, 2020.
  2. Customs Notice 20-12 provides importers with helpful information concerning the tariff classification and other potentially useful information for the importation of certain medical supplies. an HS Classification Reference for COVID-19 Medical Supplies that can be referenced for any tariff classifications related to high demand medical supplies.
  3. Customs Notice 20-08 provides importers with information on the use of the Goods for Emergency Use Remission Order (“the Order”), (C.R.C., c. 768), (the “Order”) and application of Tariff Item No. 9993.00.00 of the Customs Tariff in response to the COVID-19 pandemic.

The Order in conjunction with Tariff Item No. 9993.00.00 allows for the relief of duty and tax for goods required for an emergency and are imported by or on behalf of federal, provincial or municipal entities involved such as centres for health care as well as by or on behalf of members of first response organizations such as police, fire and local civil defence groups, including medical response teams. As of April 6 2020, these goods may also be imported by or on behalf of public or private care residences, such as seniors’ residences, retirement homes, nursing homes and shelters.

Note: Other persons than those listed in the paragraph above are not eligible for this relief.

Health Canada Licences

The term “medical device” covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices. Medical devices are categorized into four classes based on the level of risk associated with their use. Class I devices present the lowest potential risk (e.g. thermometers) and Class IV devices present the greatest potential risk (e.g. pacemakers).

There are two types of licences issued by Health Canada for medical devices sold in Canada. The first is a licence for the actual device itself and the second is a licence for the establishment (company). The device licence is called a Medical Device Licence (MDL) while the establishment licence is called a Medical Device Establishment Licence (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

A Medical Device Establishment Licence is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada. An MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance.

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence.

The following entities are exempt from holding an MDEL:

  • a retailer;
  • a healthcare facility;
  • a manufacturer of Class II, III or IV medical devices that only sells:
  • medical devices for which they hold a valid licence, or
  • medical devices subject to Parts 2 and 3 of the Medical Devices Regulations
  • a manufacturer of a Class I medical device that imports or distributes solely through a licenced establishment;
  • a person solely selling medical devices subject to Parts 2 and 3 of the Regulations; and
  • a dispenser.

Masks

  1. Products such as masks/respirators to protect against pathogens or prevent exposure to disease, surgical masks or N95 respirators intended to reduce exposure to pathogens or any product intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals is considered a medical device regulated by Health Canada.
  2. If it is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids – it is therefore regulated as a medical device by Health Canada.
  3. Surgical, procedure or medical Masks and N95 Masks are Class 1 medical devices and importers are required to hold a Medical Device Establishment License (MDEL). A MDEL is issued for the activities of importing and selling medical devices for human therapeutic use in Canada.

Imports of Class II Medical Devices (i.e. Oxygen Masks, Gas Masks, Aerosol Administration Masks) require a MDL for the actual device and a MDEL for the importer’s establishment.

  1. If the Importer requires a license: Medical Device Establishment Licence (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 mdel.application.leim.sc@canada.ca. Authorization will be granted based on an attestation to the requirements.
  2. General Purpose Masks (e.g. hygiene, at-home cleaning masks, for use in a nail salon, for use in food service, etc.) in other words, those NOT for use in healthcare settings (i.e. surgical or procedure masks). These masks do not act as a barrier to prevent droplets from an infected source from contaminating the skin and mucous membranes of the nose and mouth of the wearer, or to trap droplets expelled by the wearer. General purpose masks that do not meet the definition of a medical device, are not typically regulated.
  3. Masks for Company’s Own Use A company who buys medical devices for use in their own company can be considered the ultimate consumer and would therefore be exempt from MDEL requirements if they meet the definition as per the Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016):

Ultimate Consumer: for the purposes of this guidance document, the “ultimate consumer” is the individual who purchases or receives a medical device for their own personal use (including use within their household) or receives treatment or diagnosis with a medical device from a health care facility or provider. Businesses that purchase medical devices solely for use by their employees during work activities (e.g. first aid kits, disposable gloves) or for incidental emergency use are also considered ultimate consumers as long as they are not in the business of offering healthcare services to employees or other individuals.

Medical Gowns

In Canada, all medical gowns (Isolation and Surgical) are classified as Class I medical devices and are subject to the Medical Devices Regulations.

Companies with a medical device establishment licence (MDEL) can import and distribute medical gowns.

To meet the demand for medical gowns, Health Canada is:

  • easing approvals of medical devices through an Interim Order,
    • under the IO, manufacturers can apply to import or sell their medical device
  • allowing medical gowns that haven’t been approved or don’t meet labelling requirements to be imported and sold
  • fast-tracking the MDEL application process for companies that want to manufacture, import or distribute medical gowns

Guidelines outline how manufacturers, importers and distributors that hold an MDEL can import medical gowns with non-compliant labelling or that aren’t approved for use in Canada.

Under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, manufacturers and importers are to report medical gown shortages.

Gloves

In Canada, all medical gloves are classified as Class II medical devices. This means they meet design, testing and manufacturing standards set by Health Canada. Non-medical gloves are not subject to the Medical Device Regulations and should not be mistaken for medical gloves.

To import and distribute licensed medical gloves in Canada, companies need a medical device establishment licence (MDEL). There are exemptions for:

  • retailers
  • health care facilities (as defined in the Regulations)
  • manufacturers that have a medical device licence (MDL)
  • manufacturers that have interim order (IO) authorization

To meet the demand, Health Canada is allowing the importation and sale of medical gloves that don’t meet labelling requirements. Guidelines outline how manufacturers, importers and distributors that hold an MDEL can import medical gloves with non-compliant labelling into Canada.

Hand Sanitizers and Disinfectants

In Canada, disinfectants are classified as non-prescription drugs and hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients.

Information for manufacturers and importers

  • Importers who currently have a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants that are covered by this measure are required to notify Health Canada in advance that they will be importing products and maintain records that will facilitate product recalls, if needed.
  • Domestic companies that do not currently have a DEL or SL to conduct activities related to hand sanitizers and disinfectants covered by this measure may submit an application for expedited review to Health Canada. Authorization will be granted based on an attestation to the requirements.
  • Domestic companies that do not currently have a DIN or NPN for a disinfectant or hand sanitizer may submit an application for expedited review to Health Canada.
  • Medical Device Establishment Licence (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 hc.mdel.application.leim.sc@canada.ca. Authorization will be granted based on an attestation to the requirements.
  • Requests to import or manufacture medical devices that may not fully meet current regulatory requirements can be submitted to: hc.mdel.application.leim.sc@canada.ca.

FREQUENTLY ASKED COVID-19 RELATED-QUESTIONS

  1. How can I get my hand sanitizer application expedited?

In order to sell a topical hand antiseptic in Canada, market authorization from Health Canada is required. The NNHPD Antiseptic Skin Cleansers (Personal Domestic Use) monograph (2018) describes the requirements necessary to receive market authorization for topical antiseptic hand cleansers intended for domestic personal use only (i.e. not commercial use).

If the product contains the ingredients isopropanol or ethanol as per the monograph, you may apply for a class I application, where the antiseptic skin cleanser monograph can be used to support the conditions of use of your product. If you wish to apply for a Class I application, please note that these applications must comply with all of the parameters of the monograph (exactly as worded in the monograph). The Natural Health Products Management of Applications Policy (NHP MAP) outlines the process applied by NNHPD to manage Product Licence Applications (PLA) for NHPs

As Health Canada is prioritizing COVID-19 related applications (for both product and site), companies will need to email the Natural and Non-prescription Health Products Directorate (NNHPD) at hc.nnhpd-dpsnso.sc@canada.ca, clearly indicating that they want to avail themselves of the Class I expedited process for hand sanitizers.  NNHPD will then initiate an ePost conversation through a special COVID-19 account and the company will need to submit an application to that account which includes:

  • A duly completed web-based Product Licence Application form
    • Please note in order to complete the form, a company code (a unique five-digit code) will be required. On the Applicant/Licensee page, the company code must be the one assigned to the applicant/licensee by the NNHPD. In order to obtain a company code, please provide the following:
      • Company Name
      • Address
      • Name of the Senior Official (The senior official is the principal contact person for the applicant or licensee, at the address given)
      • Senior Official’s telephone number
      • Senior Official’s email address

Please ensure that you completely meet our product licence application requirements prior to submitting, in order to facilitate an expedited review. Please note that the expedited performance standard for these submissions will be provided shortly (e.g. for Class I, 10 days).

  1. How long will it take to get a Product Licence?

For NHP Class I (monograph submissions) applications, an NPN will be issued to applicants by 10 calendar days.

  1. What are the current interim measures for Site Licences?

As an interim measure, domestic companies that do not currently have a site licence (SL), but with a capacity to produce antiseptic skin cleansers (i.e. hand sanitizers) will be issued a site licence under an interim process.

The company will need to email the Natural and Non-prescription Health Products Directorate (NNHPD) at hc.nnhpd-dpsnso.sc@canada.ca, clearly indicating that they want to avail themselves of the interim SL process.  NNHPD will then initiate an ePost conversation through a special COVID-19 account and the company will need to submit an application to that account which includes:

The company will not need to submit a Quality Assurance Report or other forms of evidence.  The licensing will be based on the attestation included as part of the application form.  For the purposes of this interim approach, the attestation will cover the following acceptable Good Manufacturing Practices (GMP) standards:

A site licence will be issued to the company in an expedited manner (24-48 hours) for the sole purpose of manufacturing antiseptic skin cleansers (i.e. hand sanitizers) as an interim measure and valid only for the duration of the COVID-19 emergency response.  Of note, the manufacturer will need to have a way to accept and submit, as needed, adverse events reports to Health Canada. 

  1. What are the current interim measure put in place regarding importation?

Currently, Health Canada is permitting the importation of some supplies that may not fully meet Canadian regulatory requirements under the Food and Drugs Act and its Regulations.

In Canada, disinfectant products are classified as non-prescription drugs and hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Typically, these products require authorization from Health Canada before they are sold in Canada and importers require a Drug Establishment Licence or Site Licence for NHPs.

As an interim measure, to help manage the spread of COVID-19, Health Canada will facilitate the importation of the following:

  • Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling; Hand sanitizers that meet the NNHPD’s Antiseptic skin cleansers monograph requirements and have a DIN or NPN for personal commercial use or for a different dosage form).
  • Products that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA

Importers of products that fall under these categories are required to notify and submit information to Health Canada prior to importation (please ask for this form) at hc.covid19healthproducts-produitsdesante.sc@canada.ca. This will enable the Department to work with the Canada Border Services Agency to facilitate importation and take action if a risk to health is identified. Companies are required to maintain records to facilitate product recalls if needed.

Notified products will be added to a public communication posted on the Health Canada website. As an added measure, Health Canada is also expediting the review of applications for market authorization related to disinfectants or hand sanitizers. Any COVID-19 related product licence applications will be reviewed using adjusted service standards.

Most chemical products represented for use in Canada as disinfectants on environmental surfaces and inanimate objects or represented for use to reprocess non-critical medical devices are regulated by Health Canada as drugs under the Food and Drugs Act. Disinfectant drugs require a pre-market assessment and assignment of a drug identification number (DIN) prior to be sold in Canada.

Examples of disinfecting products which require a DIN include:

  • Clorox Disinfecting Wipes
  • Clorox Kitchen Cleaner and Disinfectant
  • Clorox Regular Bleach2 with CLOROMAX®
  • PURELL® Hand Sanitizing Wipes
  1. What are the requirements to import hand sanitizers for a company’s own internal use? (not for resale).

If the product is registered in a PIC/S or MRA country (e.g. NDC number), you would be eligible to a level 2 Notification process if the medicinal ingredients are captured by the HC’ monograph for antiseptics.

Thus, if you don’t have a SL or DEL and wish to import products for internal company use only, Health Canada requires companies attest to the following:

  • The importation of the unauthorized products are for use in the company’s facilities and not for further distribution and sale in Canada;
  • The importation of the unauthorized product is essential to ensure the continuity of business and to protect the health and safety of workers in company’s facilities in Canada;
  • The company will utilize adequate measures to facilitate the safe use of these unauthorized products within their facilities in Canada;
  • All records pertaining to the importation of the unauthorized products will be made available to Health Canada upon request.

Importers of hand sanitizers within this category are required to notify and submit a completed level 2 Notification form to Health Canada prior to importation (please ask for this form) at hc.covid19healthproducts-produitsdesante.sc@canada.ca. the Notification form must include the product label and the proof of registration in a PIC/S or MRA country.

In addition, please confirm on the Notification form that the grade of alcohol used in the product is pharmacopoeial or food grade. Consult Health Canada’s “Interim guide on the production of ethanol for use in alcohol based hand sanitizers“.

However, if the product is not registered in a PIC/S or MRA country, importer’s will be required to obtain an expedited COVID Site Licence (for alcohol based hand sanitizers only) and also a product licence (NPN for alcohol based hand sanitizers and DIN for non-prescription drug ingredients).