Archive for March, 2020

Importing masks, respirators and other goods in response to COVID-19

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We’re receiving a lot of requests for more information on how to import masks and other medical equipment in response to the COVID-19 emergency. Canada Customs has issued an order relieving duty and tax on these products where they are being imported on behalf of emergency workers and government agencies.*

Please find below our best answers:

What items are considered as being for ’emergency use’ and qualify for duty relief?

Anything being imported by or the behalf of emergency health workers and government agencies in response to the COVID-19 crisis. There is no specific list, although additional documentation proving the goods qualify may be requested.

As of May 6th, most goods providing protection from contagion can now be imported duty-free, regardless of who the end user will be. A complete list is available on the CBSA website.

Do I need a special permit to import emergency goods?

For non-regulated articles only a valid business number will be required in order to import. For most medical devices (including N95 masks), an MDEL (Medical Device Establishment License) is required. Note that while Health Canada is expediting MDEL applications, you may need to pay a substantial fee to apply.

For other articles, please find a list below:

  • Denatured alcohol: only importers with a federal spirits license are able to import this product (this may change, but we’ve yet to see a notification).
  • medical devices/machines: an MDEL will likely be required. Check here to see if your business is licensed.
  • hand sanitizer: considered a Natural Health Product.
    • if for re-distribution: Usually importers will require a Drug Establishment Licence or Site Licence in order to redistribute (if the sanitizer will be re-sold to consumers, contact Health Canada first to ensure the product is eligible and you may act as the importer of record).
    • personal use or exclusively for use within your organization: If the sanitizer is meant only for use within an organization or for personal use, it can typically be imported without needing consent from Health Canada.
  • face masks (not surgical or N95): not all face masks are regulated as surgical or N95 masks and therefore not subject to additional regulation, although we have no guidance on what determines this — we recommend contacting Health Canada when in doubt (see below).
  • surgical masks: see below
  • N95 masks and respirators for redistribution
    • Rule of thumb: If you are importing Class I medical equipment (i.e. masks and gowns) for your own use or for use exclusively by your business and its employees during work  activities (i.e. not to be re-sold and redistributed), you may be considered to be the ‘ultimate consumer’ and likely exempt from requirements to obtain an MDEL. (see GUI-0016 Explanatory Notes).

 

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

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 hc.mdel.questions.leim.sc@canada.ca

Fast-tracking approval of masks in Canada
Health Canada is fast-tracking the MDEL application process for companies that want to manufacture, import or distribute Class I masks. Our goal is to complete the process within 24 hours from the time we receive a completed application.Companies that need an MDEL application fast-tracked should:

-contact hc.mdel.application.leim.sc@canada.ca to obtain the MDEL Application Form (FRM-0292)

-complete the form
-indicate in the subject line of the email: URGENT COVID-19 MDEL application for “-name of company”
-email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca

What if I am not importing on behalf of the gov’t or health workers?

You may still import these articles even if the consumers will not be government or health affiliated, but duty and tax may apply.

How do I Customs clear the goods and take advantage of CN20-08?

If you do not already have an account with a customs broker, you may use the autoclear wizard on our home page. Your customs broker will apply the special authorization for duty relief if you are eligible.

 

Sources:

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/masks-respirators-covid19.html#a5

https://www.cbsa-asfc.gc.ca/publications/cn-ad/cn20-08-eng.html

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php#

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/licences/directives/gui-0016-eng.pdf

https://www.cbsa-asfc.gc.ca/publications/cn-ad/cn20-12-eng.html

https://www.cbsa-asfc.gc.ca/publications/cn-ad/cn20-19-eng.html

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Ecommerce, Customs and You provides answers to your questions on importing goods, written by the Border Bee staff.

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