During the COVID-19 pandemic, the demand for Personal Protective Equipment (PPE) has resulted in increased global sourcing for the much needed items, while emergency domestic manufacturing is getting underway, in order to protect healthcare workers and front line responders.
Imports of PPE into Canada must fulfill regulations of both the Canada Border Services Agency (CBSA) and Health Canada. The demand for PPE has also resulted in certain countries, e.g. China and the U.S., implementing export controls which may delay or negate exports and corresponding imports into Canada.
Following is a rundown of the latest information from CBSA, Health Canada and on China and USA export delays:
The CBSA issued Customs Notice 20-12 “COVID-19: Tariff Classification and Other Information to Import Medical Supplies”, to provide useful information relating to the commercial import of medical supplies, as defined by the World Customs Organization (WCO).
This notice provides a detailed list of COVID-19 medical supplies along with available duty and tax relief, in certain circumstances, and how to assess the value for duty of donated supplies:
- Customs Notice 20-08: Imported Goods for Emergency Use in Response to COVID-19
- Memorandum D10-15-26: Goods to be employed in a Noxious Atmosphere
- Customs Valuation Handbook: How To Establish The Value For Duty of Imported Goods
Due to the unprecedented demand and urgent need for PPE, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This Interim Order outlines how to import and sell designated medical devices and the corresponding regulatory requirements for the List of Medical Devices for Exceptional Importation and Sale.
- Importing or distributing masks and respirators that aren’t approved in Canada
- Manufacturers and importers may wish to import masks and respirators that haven’t been approved. Non-compliance means the product:
- is past its expiry date
- is a non-medical grade
- may not have a bilingual label
- Health Canada is fast-tracking the MDEL application process to manufacture, import or distribute Class I masks from the previous 120 days to within 24 hours
- To import non-compliant masks, manufacturers and importers should:
- complete the HC Personal Protective Equipment (PPE) – Notification form
- include “COVID – Notification” in the subject line of the email to help Health Canada fast-track requests
- email the completed form along with a copy of the product label to email@example.com
- Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing
- In Canada, disinfectants are classified as non-prescription drugs. Hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Class I personal protective equipment (such as masks and gowns) and swabs are regulated as medical devices in Canada.
- While these products are typically subject to regulatory requirements, such as licensing and bilingual labelling, Health Canada will allow certain products to be sold in Canada under this interim measure, including:
- products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling, different packaging from what was authorized); and
- products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.
- The Government of Canada’s Buy and Sell web page covers Specifications for COVID-19 Products by category of item.
Following widespread complaints of defective PPE, the Chinese authorities are enforcing stringent new export requirements encompassing quality control and customs inspections. Due to these measures, costs have significantly increased for export clearance due to extra requirements and increased processing time.
Specifically, exports of the following products require certification from authorized testing laboratories, copies of the manufacturer’s business license and the manufacturer’s certificate from China’s National Medical Products Administration:
- COVID-19 test kits
- medical protective clothing
- medical protective masks
- medical surgical masks
- one-time use medical masks
- infrared thermometers
On April 10th, 2020, the Federal Emergency Management Agency (FEMA) issued a notice in the Federal Registry to prohibit the export of PPE outside of the USA as it threatened domestic supplies. This notice includes country specific exceptions for PPE destined for use in Canada and Mexico.
In order to export PPE from the USA, export declarations must also contain a letter of attestation confirming the use and ultimate destination of the goods. FEMA will require the letter of attestation to be submitted to them via U.S. Customs and Border Protection (CBP) document imaging system and placed on file with CBP. The letter must identify the purpose of the shipment of covered materials and that the items being shipped are for use in and not for transshipment through Canada or Mexico. CBP issued a corresponding notice to outline this information.
As exports from the USA to Canada do not require an export declaration, it is recommended to provide a copy of the letter of attestation to the carrier with shipment documentation in the event it is requested.