We have been hearing from many companies regarding the importing of personal protective equipment as well as sanitizers to meet the need during the current COVID-19 pandemic.
There has been a response by the Canadian and US governments to expedite the process in order to ensure that these much-needed items are being received as quickly as possible.
Health Canada is expediting applications for Medical Device Establishment Licences (MDELs) in order to address the demand and need for Personal Protective Equipment (PPE) including N95 face piece respirators, gowns, masks, face shields, isolation units, pods or rooms intended for transporting infected and contaminated patients and nasal pharyngeal swabs. The turnaround for the issuance of an MDELs was previously 120 days, however, due to the pressing need for these supplies, this has been expedited to 24 hours for COVID-19 Class 1 requests. Additionally, Health Canada is temporarily allowing certain products to be sold in Canada that do not meet the labelling, licensing and packaging requirements in order to meet the demand. Please see the Government of Canada link below for more details.
In the United States, the process to import products related to COVID-19 has also been temporarily expedited in order to meet public health needs. Personal protective equipment is categorized into three different groups:
- Non-FDA regulated general-purpose PPE (masks, respirators, gloves etc)
- PPE for general purpose use or industrial use (not intended for use to prevent illness or disease) is not regulated by the FDA.
- Products authorized for emergency use under Emergency Use Authorization (EUA)
- Entry information should be submitted to FDA, reduced FDA information required.
- Medical device products and regulated as such with NO EUA but where an enforcement discretion policy has been published in guidance
- Entry information should be submitted to FDA and transmit with intended use code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code.
Helpful Links:
- World Customs Association:
HS classification reference for COVID-19 medical supplies - Government of Canada: Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing
- MDEL Application Form (FRM-0292)
- US CBP CSMS #42124872: Information for Filing Personal Protective Equipment and Medical Devices During COVID-19
- Detroit Field Office Pipeline Pandemic Materials – notice to provide advanced notification for pandemic relief materials
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Buckland will continue to support our clients and employees as we together navigate through these unchartered times and thank you for your ongoing partnership.